EMPOWER: Empowered With Movement to Prevent Obesity and Weight Regain

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02923674
• Collaborator: Wake Forest University (Other), National Institute on Aging (NIA) (NIH)
• Enrollment: 183
• Location: 1
• Arms: 3
• Actual Duration (Months): 45.8
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

This study will help determine the appropriate type, amount and intensity of physical activity most beneficial for preventing weight regain after weight loss in older adults.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Weight Loss; Sedentary Lifestyle	Behavioral: Weight loss; Behavioral: Exercise; Behavioral: Sitless	N/A

Detailed Description

The investigators will use a 3-group design in 180 older (65-85 years), obese (BMI=30-45 kg/m2), sedentary men and women, all of whom will undergo a 9-month Weight Loss (WL) intervention (6-mo intensive phase and 3-mo reduced contact phase), followed by a 9-month self-managed follow-up phase with minimal contact, to test our overall hypothesis that intervening on Sedentary Behavior (SitLess) will enhance long-term Weight Loss in this age group. The diet element of the intervention is identical across groups, but groups differ by activity intervention: 1) structured, moderate-intensity, aerobic exercise (EX) (WL+EX); 2) intervening on SB throughout the day (WL+SitLess); or 3) (WL+EX+SitLess).

Study Design

• Study Type: Interventional
• Actual Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Empowered With Movement to Prevent Obesity and Weight Regain
• Actual Study Start Date: Dec 6, 2016
• Actual Primary Completion Date: Oct 1, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Weight loss + sitless All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. Participants will be encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).	Behavioral: Weight loss; All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.; Other Names: WL ; Behavioral: Sitless; Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).; Other Names: SL
Other: Weight loss + exercise All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. Participants will be asked to perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week.	Behavioral: Weight loss; All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.; Other Names: WL ; Behavioral: Exercise; Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.; Other Names: EX
Other: Weight loss + exercise + sitless All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. Participants will be encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3). Participants will be asked to perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week.	Behavioral: Weight loss; All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.; Other Names: WL ; Behavioral: Exercise; Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.; Other Names: EX ; Behavioral: Sitless; Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).; Other Names: SL

Outcome Measures

Primary Outcome Measures

1. Body Weight [Baseline]

   Measured in clinic on the same scale

2. Body Weight [6 months]

   Measured in clinic on the same scale

3. Body Weight [18 months]

   Measured in clinic on the same scale

Other Outcome Measures

1. Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale [Baseline (0mo), 6mo, 18mo]

   13 item scale used to measure fatigue over the past week with a 4-point Likert scale. The score range is 0-52 with a score of less than 30 indicating severe fatigue, and higher score denoting a better quality of life.

2. Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 8a [Baseline, 6mo, 18mo]

   DAn 8 item questionnaire that assess fatigue over the past 7 days. All items are summed with the lowest possible score equaling 8 and the highest, a 40. A higher score indicates more fatigue.

3. Pittsburg Fatigability Questionnaire [Baseline, 6mo, 18mo]

   10 item scale that assesses fatigability (fatigue in the context of a standardized task). A higher score indicates a higher performance fatigability, slower gait speed, worsening physical function. A 10 item scale that assesses fatigability (fatigue in the context of a standardized task). Score range is 0-50 with a higher score = a higher performance fatigability, slower gait speed, worsening physical function.

4. Short Form 36 Item (SF-36) Health Survey [Baseline, 6mo, 18mo]

   A 36 item survey of overall health broken into 8 scaled scores of vitality, physical function, pain, general health, mental health, social, physical, and emotional role functioning. Ranging from 0 to 100, the lower a person scores, the more disability.

5. Self-Efficacy for Walking Scale [Baseline, 6mo, 18mo]

   Self-reported measure used to determine a person's belief in their physical capability to successfully complete incremental walking distances (5-40 minutes) at a moderate pace. The total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.

6. Satisfaction With Physical Function Questionnaire [Baseline, 6mo, 18mo]

   A scale testing how satisfied an individual is with their physical fitness and abilities. Levels of satisfaction are rated on a 7 point scale from very dissatisfied to very satisfied. All items are then averaged to create a score ranging from -3 to 3.

7. Self-Efficacy for Managing Eating Questionnaire [Baseline, 6mo, 18mo]

   Used to measure self-efficacy for appropriate eating using 5 subscales (Negative Emotions, Availability, Social Pressure, Physical Discomfort, Positive Activities) of 4 items each (e.g., "I can resist eating even when high-calorie foods are available"). Item responses range from 0 (not confident) to 9 (very confident). An average score is created for each subscale and then a total score by averaging across all items. On a scale from 10 to 40, higher scores represent greater confidence in being able to restrain oneself from eating under difference contexts.

8. Experiences in Close Relationships Questionnaire [Baseline, 6mo, 18mo]

   Scale used to evaluate the construct of adult attachment by examining avoidance and anxiety. A person rates each statement about connection using a 7-point Likert scale which ranges from 1 (strongly disagree) to 7 (strongly agree). To obtain score, average responses from all 36 items. A score will range from 7 to 42 with a higher score representing insecure attachment.

9. Mindful Attention Awareness Scale (MAAS) [Baseline, 6mo, 18mo]

   15-item questionnaire used to assess the core characteristic of mindfulness, or an awareness of and attention to what is taking place in the present. The 15 items are collected in a Likert scale, totaled, and averaged for a final score ranging from 1-7. A higher score reflects higher levels of mindfulness and a lower score is indicative of a negative emotional state.

10. Power of Food Questionnaire [Baseline, 6mo, 18mo]

    Scale assessing the psychological impact of living in food-abundant environments. It measures appetite for, rather than consumption of, palatable foods, at three levels of food proximity (food available, food present, and food tasted).

11. Perceived Stress Scale [Baseline, 6mo, 18mo]

    A questionnaire used to measure the perception of stress and how often a person felt that way in the last month. Individual scores range from 0 to 40 with higher scores indicating a person perceives higher levels of stress which could lead to or correlate with negative behaviors such as stress eating or decreases in physical activity

12. Food Cravings Questionnaire [Baseline, 6mo, 18mo]

    15-item measure of short-term changes in food cravings. Responses are made on a five-point Likert scale with response categories ranging from 1 (strongly disagree) to 5 (strongly agree). The scale yields a sum total from the five subscale scores, including, 1) an intense desire to eat; 2) anticipation of positive reinforcement that may result from eating; 3) anticipation of relief from negative states and feelings as a result of eating; 4) obsessive preoccupation with food or lack of control over eating; and 5) craving as a physiological state. Sum scores range from 15 to 90 with higher scores representing more frequent and intense experiences of craving food.

13. Technology Survey [6mo, 18mo]

    Administered during assessment visits to gain insight on the participants' opinion of the technology (i.e., Empower application and web-based questionnaires, any tests/emails received from the Empower team) used in the study. Examples of these open-ended questions include: 1) How useful did you find the Empower smartphone app?; 2) To what extent was the Empower app a burden to use?; 3) How difficult or easy was the app to use?; 4) How important did you feel the app was to your experience in the Empower study?; 5) What were one or two of your favorite and least favorite features of the Empower app? Questions were not scored or used in data analysis, but provided staff with an overall user opinion as well as constructive criticism in order to improve similar technologies in future studies.

14. Intervention Survey [6 mo, 18 mo]

    Administered at assessment visits to gain inside on the participants' opinion on the group dynamic used in the first 6 months of the study. Examples of the dichotomous questions include: 1) Did you enjoy working with the staff and participants?; 2) Did you feel pressured by staff and or participants to do well in the study?; 3) Did you get along with the staff and participants in Empower?; 4) Did you feel comfortable expressing your ideas and opinions to staff members and fellow participants?; 5) Do you feel people a part of the Empower study care about you? Questions were not scored or used in data analysis, but provided staff with an overall opinion of participant experience as well as constructive criticism in order to improve similar group settings in future studies.

15. Anthropometric Measures [Baseline, 6mo, 18mo]

    Three anthropometric measures at three anatomical locations are taken using a handheld measuring table with tension and recorded in centimeters. The waist measurement is taken at the narrowest part of the torso below the ribcage and above the umbilicus. The hip measurement is measured at the maximal circumference of the buttocks. The mid-thigh is taken with the knee bent to 90°, midway between the inguinal crease and the proximal border of the patella. The measurements taken at each site are averaged. A waist/hip ratio is calculated.

16. Expanded Short Physical Performance Battery (eSPPB) [Baseline, 6mo, 18mo]

    Consists of a test of balance, gait speed test, and chair stand, performed in this order. The following equipment is required for the expanded SPPB: digital stopwatch, masking tape, measuring tape, script, and a straight-backed armless chair with a hard seat. To eliminate the effect of different footwear on test performance, tests are performed in tennis shoes or comfortable walking shoes with minimal or no heels. Tests are individually scored 0-4 and then totaled for a maximal score of 12. The higher a score, the better an individual's mobility and functional ability.

17. Treadmill Fatigability [Baseline, 6mo, 18mo]

    Test is done on a treadmill to assess perceived fatigability at a given workload. Participants are asked to rate their RPE (rating of perceived exertion) just as they start walking (0 min, 2.0 mph), half way through (2.5 min, 2.0 mph), and at the end of the test (5 min, 2.0 mph). Heart rate via a heart rate monitoring watch will be recorded at these same intervals.

18. Peak Aerobic Capacity (VO2) Peak [Baseline, 6mo, 18mo]

    Measured during a maximal graded exercise test (GXT) to exhaustion on a treadmill using a Raise, Activate, Mobilise, Potentiate (RAMP) protocol. The GXT is used to rule out any latent coronary artery disease and to measure cardiovascular functional capacity and peak oxygen uptake. The respiratory rate, minute ventilation, breathing reserve, VO2, Validation of Carbon Dioxide Production (VCO2), respiratory exchange ratio, one metabolic equivalent (MET) level, heart rate (HR), VO2/HR, kilocalorie/minutes (Kcal/min), Rating of Perceived Exertion (RPE) and Blood pressure (BP) at test conclusion are recorded.

19. Grip Strength [Baseline, 6mo, 18mo]

    The Jaymar Handheld Dynamometer is used to measure grip strength in both hands. To the nearest and highest kilogram achieved, hand grip strength is a commonly used measure of upper body skeletal muscle function and has been widely used as a general indicator of frailty with predictive validity for both mortality and functional limitation.

20. Resting Metabolic Rate (RMR) [Baseline, 6mo, 18mo]

    A facemask will be placed on the participant while he/she is lying on the exam table. Measures of oxygen consumption and carbon dioxide production will be collected continuously for 30 minutes and the RMR will be calculated using the Weir equation.

21. Activity Monitor [Baseline, 6mo, 18mo]

    Used to evaluate time spent in sedentary behavior, light, and moderate to vigorous physical activity (MVPA). An activPAL™ accelerometer (PAL Technologies, Glasgow, Scotland) is worn for 7-days at each of the three assessment visits: baseline, 6-months and 18-months. The monitor uses accelerometer-derived information about thigh position to estimate time spent in different body positions: lying or sitting = sedentary; standing still; and stepping = light and MVPA. Data is downloaded at the end of each 7-day period and cleaned and summarized for statistical analyses. The proprietary algorithm in the activPAL software is used to generate estimates of (a) Total Daily Energy Expenditure (TDEE); (b) sedentary time during the day, (c) number of breaks in sedentary time, (d) minutes spent in light activity, and (e) number of minutes spent in MVPA.

22. Ecological Momentary Assessment (EMA) [Baseline, 6mo]

    Used to determine the relationship between dynamic food variables, physical activity variables, and long-term weight loss. Prior to the start of the intervention and following the initial intervention period, participants complete week-long daily assessments. The following are the different scales and questions asked of participants: 1) Affective Valence from the Feelings Scale (scored 0 - 10 where 0 = very bad and 10 = very good). 2) Six items from the exercise-induced feelings inventory, each on a 0 ="do not feel" to 10="feel very strongly" score. Calm, peaceful, and relaxed are then averaged for a "tranquility" subscale; "fatigued, "tired" and "worn-out" are averaged for a physical exhaustion subscale. 3) Hunger was queried by "How hungry are you right now?" where 0 = not at all hungry, and 10 = very hungry. 4) An individual's craving for food was queried by "How much do you crave eating your favorite food or snack right now?" where 0 = "do not feel" and 10 = "feel very strongly".

23. 400 Meter Walk Test [Baseline, 6mo, 18mo]

    Test is completed at a quick pace (without running) that the participant can maintain over the flat, 400 meter course. Timing begins when the participant takes his/her first step. Timing ends when the participant's whole foot crosses the line at the end of the 10th lap or the participant requests to stop. Recorded is the distance completed and time walked in minutes and seconds.

24. Walking Efficiency [Baseline, 6mo, 18mo]

    Used to determine the number of calories burned while walking at 2.0 mph on a treadmill with zero grade. Heart rate (HR) is measured continuously using a heart rate monitoring watch and will be recorded every minute. Blood pressure (BP) is monitored and recorded every minute. The test is terminated when the (HR) remains at a steady state (is within 5 beats per minute of the HR from the previous minute). The time to achieve steady state heart rate, the respiratory rate, minute ventilation, breathing reserve, VO2, VCO2, respiratory exchange ratio, MET level, HR, VO2/HR, Kcal/min, and the BP at steady state are recorded.

25. Visceral Fat [Baseline, 6mo, 18mo]

    A visceral fat measurement is obtained through a dual-energy X-ray absorptiometry (DEXA) whole body scan in a 5-cm wide region across the entire abdomen just above the iliac crest at a level approximate with the 4th lumbar vertebrae. Mass visceral fat is measured to the nearest gram and volume to the nearest centimeter.

26. Bone Mineral Density (BMD) [Baseline, 6mo, 18mo]

    Hip and spine BMD is measured using specific scans of the anterior-posterior spine Lumbar vertebrae 1-Lumbar vertebrae 4 (L1-L4) and proximal femur by dual-energy X-ray absorptiometry. BMD is recorded as a t-score with a lower score indicative of less bone density and increased risk for osteoporosis.

27. Cardiometabolic Risk Factors--Lab Work [Baseline, 6mo, 18mo]

    An 8-hour fasting venous blood sample is collected to measure cardiometabolic changes lipoprotein lipids, C-reactive protein, HbA1c, glucose and insulin.

28. Satisfaction With Physical Function [Baseline, 6mo, 18mo]

    Scale used to test how satisfied participants are with their physical fitness, functional ability, and physical appearance. Participants rate their level of satisfaction on a 7-point scale from very dissatisfied to very satisfied. Average all items to create a score ranging from -3 to 3. Higher values represent greater satisfaction with physical function and importance.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 65-85 years

• BMI=30-45 kg/m2

• Weight stable-no loss or gain (±5%) in past 6 mo

• Sedentary

• No contraindication for safe and optimal participation in exercise training

• Approved for participation by Medical Director

• Willing to provide informed consent

• Agree to all study procedures and assessments

• Able to provide own transportation to study visits and intervention

Exclusion Criteria:

• Dependent on cane or walker

• Reported unintentional or intentional weight loss or gain of >5% in past 6 mo Participation in regular resistance training and/or > 20 mins/day of aerobic exercise in past 6 months

• Cognitive impairment (MoCA score <22)

• Low bone density (T-score < -2.3 on hip or spine scan)

• Severe arthritis, or other musculoskeletal disorder

• Joint replacement or other orthopedic surgery in past 6 mos

• Joint replacement or other orthopedic surgery planned in next 2 years

• Uncontrolled resting hypertension (>160/90 mmHg);

• Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease other than asthma or COPD, any disease requiring oxygen use, neurological or hematological disease; cancer requiring treatment in past year, except non-melanoma skin cancers

• Serious conduction disorder, new Q waves or ST-segment depression (>3 mm), or uncontrolled arrhythmia

• Room air SpO2 (oxygen saturation) at rest or with exercise qualifying for supplementary oxygen (SpO2≤88%)

• Abnormal kidney or liver function (2x upper limit of normal);

• eGFR <45 mL/min/1.73m2

• Anemia (Hb<13 g/dL in men/ <12 g/dL in women);

• Uncontrolled diabetes (fasting glucose >140 mg/dl);

• Deficient levels of vitamin D (25 hydroxyvitamin D level < 20 ng/mL) in those not taking a vitamin D supplement;

• Smoker (No nicotine in past yr)

• No heavy alcohol use (>14 drinks/week)

• Unstable severe depression

• Regular use of: growth hormones, oral steroids, weight loss medications or prescription osteoporosis meds

• Current participation in other research study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest Baptist Health Sticht Center on Aging	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

• Wake Forest University Health Sciences
• Wake Forest University
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Barbara Nicklas, PhD, Wake Forest University Health Sciences
• Principal Investigator: W. Jack Rejeski, PhD, Wake Forest University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 3, 2020
• Informed Consent Form - Aug 3, 2020

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02923674
• Other Study ID Numbers: IRB00035300; R01AG051624; R01AG051624-02S1; R01AG051624-02S2
• First Posted: Oct 4, 2016
• Last Update Posted: Mar 23, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Body Weight; Weight Loss

Study Results

Participant Flow

Arm/Group Title	Weight Loss + Exercise + Sitless	Weight Loss + Exercise	Weight Loss + Sitless
Arm/Group Description	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).
Period Title: Overall Study
STARTED	60	60	63
COMPLETED	32	32	38
NOT COMPLETED	28	28	25

Baseline Characteristics

Arm/Group Title	Weight Loss + Exercise + Sitless	Weight Loss + Sitless	Weight Loss + Exercise	Total
Arm/Group Description	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.	Total of all reporting groups
Overall Participants	60	63	60	183
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.6 (4.0)	69.6 (4.6)	70.7 (4.1)	70.2 (4.2)
Sex: Female, Male (Count of Participants)
Female	46 76.7%	47 74.6%	48 80%	141 77%
Male	14 23.3%	16 25.4%	12 20%	42 23%
Race/Ethnicity, Customized (Count of Participants)
White	42 70%	49 77.8%	45 75%	136 74.3%
Black	18 30%	14 22.2%	15 25%	47 25.7%
Region of Enrollment (participants) [Number]
United States	60 100%	63 100%	60 100%	183 100%
Education (>High School) (Count of Participants)
Count of Participants [Participants]	57 95%	49 77.8%	52 86.7%	158 86.3%
Cognitive Status (MoCA) Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	26.2 (2.3)	26.1 (2.2)	25.3 (2.2)	25.86 (2.27)
Depression (CES-D) Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.4 (5.1)	6.0 (5.2)	6.48 (6.4)	6.31 (5.57)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	165.0 (7.5)	165.4 (9.3)	162.2 (8.9)	164.3 (8.6)
Body Mass (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	96.8 (12.8)	97.2 (14.3)	94.3 (14.0)	95.8 (13.9)
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	35.4 (3.7)	35.4 (3.8)	35.5 (3.8)	35.4 (3.8)
Waist to Hip Ratio (ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ratio]	0.88 (0.10)	0.90 (0.09)	0.88 (0.10)	0.9 (0.3)
Gait Speed (m/sec) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [m/sec]	1.00 (0.17)	1.03 (0.19)	1.00 (0.16)	1.0 (0.2)
Short Physical Performance Battery (SPPB) Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	10.8 (1.1)	10.5 (1.4)	10.7 (1.4)	10.7 (1.3)
Expanded Short Physical Performance Battery (eSPPB) Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.2 (0.3)	2.2 (0.4)	2.3 (0.3)	2.2 (0.3)
Aerobic fitness (VO2peak; ml/kg/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [VO2peak; ml/kg/min]	22.2 (4.8)	20.3 (5.0)	21.2 (3.9)	20.6 (4.1)
Resting Seated Blood Pressure--Systolic (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	132 (13)	135 (12)	135 (13)	134.8 (14.2)
Resting Seated Blood Pressure Diastolic (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	82 (8)	81 (8)	82 (7)	82 (8.9)
Self-reported comorbidity Hypertension (Count of Participants)
Count of Participants [Participants]	40 66.7%	36 57.1%	43 71.7%	119 65%
Self-reported comorbidity Diabetes (Count of Participants)
Count of Participants [Participants]	7 11.7%	11 17.5%	5 8.3%	23 12.6%
Self-reported comorbidity Sleep Apnea (Count of Participants)
Count of Participants [Participants]	24 40%	19 30.2%	19 31.7%	62 33.9%
Self-reported comorbidity Osteoarthritis (Count of Participants)
Count of Participants [Participants]	42 70%	43 68.3%	43 71.7%	128 69.9%
Self-reported comorbidity Osteopenia (Count of Participants)
Count of Participants [Participants]	14 23.3%	9 14.3%	15 25%	38 20.8%
Anti-hypertensive Medication use (Count of Participants)
Count of Participants [Participants]	42 70%	41 65.1%	44 73.3%	127 69.4%
Cholesterol-lowering Medication use (Count of Participants)
Count of Participants [Participants]	32 53.3%	30 47.6%	33 55%	95 51.9%
Glucose control Medication use (Count of Participants)
Count of Participants [Participants]	6 10%	11 17.5%	4 6.7%	21 11.5%
Anti-depressant/mood Medication use (Count of Participants)
Count of Participants [Participants]	16 26.7%	16 25.4%	20 33.3%	52 28.4%

Outcome Measures

1. Primary Outcome

Title	Body Weight
Description	Measured in clinic on the same scale
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The CONSORT represents all 6 waves while our results only include data for Waves 1-4 due to COVID restrictions impacting the 18mo visit data for Waves 5 and 6.

Arm/Group Title	Weight Loss + Exercise + Sitless	Weight Loss + Exercise	Weight Loss + Sitless
Arm/Group Description	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).
Measure Participants	26	31	31
Mean (Standard Deviation) [kg]	94.7 (10.2)	91.6 (14.3)	95.1 (14.3)

2. Primary Outcome

Title	Body Weight
Description	Measured in clinic on the same scale
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

The CONSORT represents all 6 waves while our results only include data for Waves 1-4 due to COVID restrictions impacting the 18mo visit data for Waves 5 and 6.

Arm/Group Title	Weight Loss + Exercise + Sitless	Weight Loss + Exercise	Weight Loss + Sitless
Arm/Group Description	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).
Measure Participants	26	31	33
Mean (Standard Deviation) [kg]	86.9 (12.4)	82.8 (11.4)	87.0 (13.3)

3. Primary Outcome

Title	Body Weight
Description	Measured in clinic on the same scale
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

The CONSORT represents all 6 waves while our results only include data for Waves 1-4 due to COVID restrictions impacting the 18mo visit data for Waves 5 and 6.

Arm/Group Title	Weight Loss + Exercise + Sitless	Weight Loss + Exercise	Weight Loss + Sitless
Arm/Group Description	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).
Measure Participants	26	31	33
Mean (Standard Deviation) [kg]	89.8 (14.3)	87.2 (13.1)	88.7 (14.3)

4. Other Pre-specified Outcome

Title	Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Description	13 item scale used to measure fatigue over the past week with a 4-point Likert scale. The score range is 0-52 with a score of less than 30 indicating severe fatigue, and higher score denoting a better quality of life.
Time Frame	Baseline (0mo), 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Other Pre-specified Outcome

Title	Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 8a
Description	DAn 8 item questionnaire that assess fatigue over the past 7 days. All items are summed with the lowest possible score equaling 8 and the highest, a 40. A higher score indicates more fatigue.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Other Pre-specified Outcome

Title	Pittsburg Fatigability Questionnaire
Description	10 item scale that assesses fatigability (fatigue in the context of a standardized task). A higher score indicates a higher performance fatigability, slower gait speed, worsening physical function. A 10 item scale that assesses fatigability (fatigue in the context of a standardized task). Score range is 0-50 with a higher score = a higher performance fatigability, slower gait speed, worsening physical function.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

Title	Short Form 36 Item (SF-36) Health Survey
Description	A 36 item survey of overall health broken into 8 scaled scores of vitality, physical function, pain, general health, mental health, social, physical, and emotional role functioning. Ranging from 0 to 100, the lower a person scores, the more disability.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Other Pre-specified Outcome

Title	Self-Efficacy for Walking Scale
Description	Self-reported measure used to determine a person's belief in their physical capability to successfully complete incremental walking distances (5-40 minutes) at a moderate pace. The total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Other Pre-specified Outcome

Title	Satisfaction With Physical Function Questionnaire
Description	A scale testing how satisfied an individual is with their physical fitness and abilities. Levels of satisfaction are rated on a 7 point scale from very dissatisfied to very satisfied. All items are then averaged to create a score ranging from -3 to 3.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Other Pre-specified Outcome

Title	Self-Efficacy for Managing Eating Questionnaire
Description	Used to measure self-efficacy for appropriate eating using 5 subscales (Negative Emotions, Availability, Social Pressure, Physical Discomfort, Positive Activities) of 4 items each (e.g., "I can resist eating even when high-calorie foods are available"). Item responses range from 0 (not confident) to 9 (very confident). An average score is created for each subscale and then a total score by averaging across all items. On a scale from 10 to 40, higher scores represent greater confidence in being able to restrain oneself from eating under difference contexts.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Other Pre-specified Outcome

Title	Experiences in Close Relationships Questionnaire
Description	Scale used to evaluate the construct of adult attachment by examining avoidance and anxiety. A person rates each statement about connection using a 7-point Likert scale which ranges from 1 (strongly disagree) to 7 (strongly agree). To obtain score, average responses from all 36 items. A score will range from 7 to 42 with a higher score representing insecure attachment.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Other Pre-specified Outcome

Title	Mindful Attention Awareness Scale (MAAS)
Description	15-item questionnaire used to assess the core characteristic of mindfulness, or an awareness of and attention to what is taking place in the present. The 15 items are collected in a Likert scale, totaled, and averaged for a final score ranging from 1-7. A higher score reflects higher levels of mindfulness and a lower score is indicative of a negative emotional state.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Other Pre-specified Outcome

Title	Power of Food Questionnaire
Description	Scale assessing the psychological impact of living in food-abundant environments. It measures appetite for, rather than consumption of, palatable foods, at three levels of food proximity (food available, food present, and food tasted).
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

14. Other Pre-specified Outcome

Title	Perceived Stress Scale
Description	A questionnaire used to measure the perception of stress and how often a person felt that way in the last month. Individual scores range from 0 to 40 with higher scores indicating a person perceives higher levels of stress which could lead to or correlate with negative behaviors such as stress eating or decreases in physical activity
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

15. Other Pre-specified Outcome

Title	Food Cravings Questionnaire
Description	15-item measure of short-term changes in food cravings. Responses are made on a five-point Likert scale with response categories ranging from 1 (strongly disagree) to 5 (strongly agree). The scale yields a sum total from the five subscale scores, including, 1) an intense desire to eat; 2) anticipation of positive reinforcement that may result from eating; 3) anticipation of relief from negative states and feelings as a result of eating; 4) obsessive preoccupation with food or lack of control over eating; and 5) craving as a physiological state. Sum scores range from 15 to 90 with higher scores representing more frequent and intense experiences of craving food.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Other Pre-specified Outcome

Title	Technology Survey
Description	Administered during assessment visits to gain insight on the participants' opinion of the technology (i.e., Empower application and web-based questionnaires, any tests/emails received from the Empower team) used in the study. Examples of these open-ended questions include: 1) How useful did you find the Empower smartphone app?; 2) To what extent was the Empower app a burden to use?; 3) How difficult or easy was the app to use?; 4) How important did you feel the app was to your experience in the Empower study?; 5) What were one or two of your favorite and least favorite features of the Empower app? Questions were not scored or used in data analysis, but provided staff with an overall user opinion as well as constructive criticism in order to improve similar technologies in future studies.
Time Frame	6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

17. Other Pre-specified Outcome

Title	Intervention Survey
Description	Administered at assessment visits to gain inside on the participants' opinion on the group dynamic used in the first 6 months of the study. Examples of the dichotomous questions include: 1) Did you enjoy working with the staff and participants?; 2) Did you feel pressured by staff and or participants to do well in the study?; 3) Did you get along with the staff and participants in Empower?; 4) Did you feel comfortable expressing your ideas and opinions to staff members and fellow participants?; 5) Do you feel people a part of the Empower study care about you? Questions were not scored or used in data analysis, but provided staff with an overall opinion of participant experience as well as constructive criticism in order to improve similar group settings in future studies.
Time Frame	6 mo, 18 mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

18. Other Pre-specified Outcome

Title	Anthropometric Measures
Description	Three anthropometric measures at three anatomical locations are taken using a handheld measuring table with tension and recorded in centimeters. The waist measurement is taken at the narrowest part of the torso below the ribcage and above the umbilicus. The hip measurement is measured at the maximal circumference of the buttocks. The mid-thigh is taken with the knee bent to 90°, midway between the inguinal crease and the proximal border of the patella. The measurements taken at each site are averaged. A waist/hip ratio is calculated.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

19. Other Pre-specified Outcome

Title	Expanded Short Physical Performance Battery (eSPPB)
Description	Consists of a test of balance, gait speed test, and chair stand, performed in this order. The following equipment is required for the expanded SPPB: digital stopwatch, masking tape, measuring tape, script, and a straight-backed armless chair with a hard seat. To eliminate the effect of different footwear on test performance, tests are performed in tennis shoes or comfortable walking shoes with minimal or no heels. Tests are individually scored 0-4 and then totaled for a maximal score of 12. The higher a score, the better an individual's mobility and functional ability.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

20. Other Pre-specified Outcome

Title	Treadmill Fatigability
Description	Test is done on a treadmill to assess perceived fatigability at a given workload. Participants are asked to rate their RPE (rating of perceived exertion) just as they start walking (0 min, 2.0 mph), half way through (2.5 min, 2.0 mph), and at the end of the test (5 min, 2.0 mph). Heart rate via a heart rate monitoring watch will be recorded at these same intervals.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

21. Other Pre-specified Outcome

Title	Peak Aerobic Capacity (VO2) Peak
Description	Measured during a maximal graded exercise test (GXT) to exhaustion on a treadmill using a Raise, Activate, Mobilise, Potentiate (RAMP) protocol. The GXT is used to rule out any latent coronary artery disease and to measure cardiovascular functional capacity and peak oxygen uptake. The respiratory rate, minute ventilation, breathing reserve, VO2, Validation of Carbon Dioxide Production (VCO2), respiratory exchange ratio, one metabolic equivalent (MET) level, heart rate (HR), VO2/HR, kilocalorie/minutes (Kcal/min), Rating of Perceived Exertion (RPE) and Blood pressure (BP) at test conclusion are recorded.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

22. Other Pre-specified Outcome

Title	Grip Strength
Description	The Jaymar Handheld Dynamometer is used to measure grip strength in both hands. To the nearest and highest kilogram achieved, hand grip strength is a commonly used measure of upper body skeletal muscle function and has been widely used as a general indicator of frailty with predictive validity for both mortality and functional limitation.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

23. Other Pre-specified Outcome

Title	Resting Metabolic Rate (RMR)
Description	A facemask will be placed on the participant while he/she is lying on the exam table. Measures of oxygen consumption and carbon dioxide production will be collected continuously for 30 minutes and the RMR will be calculated using the Weir equation.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

24. Other Pre-specified Outcome

Title	Activity Monitor
Description	Used to evaluate time spent in sedentary behavior, light, and moderate to vigorous physical activity (MVPA). An activPAL™ accelerometer (PAL Technologies, Glasgow, Scotland) is worn for 7-days at each of the three assessment visits: baseline, 6-months and 18-months. The monitor uses accelerometer-derived information about thigh position to estimate time spent in different body positions: lying or sitting = sedentary; standing still; and stepping = light and MVPA. Data is downloaded at the end of each 7-day period and cleaned and summarized for statistical analyses. The proprietary algorithm in the activPAL software is used to generate estimates of (a) Total Daily Energy Expenditure (TDEE); (b) sedentary time during the day, (c) number of breaks in sedentary time, (d) minutes spent in light activity, and (e) number of minutes spent in MVPA.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

25. Other Pre-specified Outcome

Title	Ecological Momentary Assessment (EMA)
Description	Used to determine the relationship between dynamic food variables, physical activity variables, and long-term weight loss. Prior to the start of the intervention and following the initial intervention period, participants complete week-long daily assessments. The following are the different scales and questions asked of participants: 1) Affective Valence from the Feelings Scale (scored 0 - 10 where 0 = very bad and 10 = very good). 2) Six items from the exercise-induced feelings inventory, each on a 0 ="do not feel" to 10="feel very strongly" score. Calm, peaceful, and relaxed are then averaged for a "tranquility" subscale; "fatigued, "tired" and "worn-out" are averaged for a physical exhaustion subscale. 3) Hunger was queried by "How hungry are you right now?" where 0 = not at all hungry, and 10 = very hungry. 4) An individual's craving for food was queried by "How much do you crave eating your favorite food or snack right now?" where 0 = "do not feel" and 10 = "feel very strongly".
Time Frame	Baseline, 6mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

26. Other Pre-specified Outcome

Title	400 Meter Walk Test
Description	Test is completed at a quick pace (without running) that the participant can maintain over the flat, 400 meter course. Timing begins when the participant takes his/her first step. Timing ends when the participant's whole foot crosses the line at the end of the 10th lap or the participant requests to stop. Recorded is the distance completed and time walked in minutes and seconds.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

27. Other Pre-specified Outcome

Title	Walking Efficiency
Description	Used to determine the number of calories burned while walking at 2.0 mph on a treadmill with zero grade. Heart rate (HR) is measured continuously using a heart rate monitoring watch and will be recorded every minute. Blood pressure (BP) is monitored and recorded every minute. The test is terminated when the (HR) remains at a steady state (is within 5 beats per minute of the HR from the previous minute). The time to achieve steady state heart rate, the respiratory rate, minute ventilation, breathing reserve, VO2, VCO2, respiratory exchange ratio, MET level, HR, VO2/HR, Kcal/min, and the BP at steady state are recorded.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

28. Other Pre-specified Outcome

Title	Visceral Fat
Description	A visceral fat measurement is obtained through a dual-energy X-ray absorptiometry (DEXA) whole body scan in a 5-cm wide region across the entire abdomen just above the iliac crest at a level approximate with the 4th lumbar vertebrae. Mass visceral fat is measured to the nearest gram and volume to the nearest centimeter.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

29. Other Pre-specified Outcome

Title	Bone Mineral Density (BMD)
Description	Hip and spine BMD is measured using specific scans of the anterior-posterior spine Lumbar vertebrae 1-Lumbar vertebrae 4 (L1-L4) and proximal femur by dual-energy X-ray absorptiometry. BMD is recorded as a t-score with a lower score indicative of less bone density and increased risk for osteoporosis.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

30. Other Pre-specified Outcome

Title	Cardiometabolic Risk Factors--Lab Work
Description	An 8-hour fasting venous blood sample is collected to measure cardiometabolic changes lipoprotein lipids, C-reactive protein, HbA1c, glucose and insulin.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

31. Other Pre-specified Outcome

Title	Satisfaction With Physical Function
Description	Scale used to test how satisfied participants are with their physical fitness, functional ability, and physical appearance. Participants rate their level of satisfaction on a 7-point scale from very dissatisfied to very satisfied. Average all items to create a score ranging from -3 to 3. Higher values represent greater satisfaction with physical function and importance.
Time Frame	Baseline, 6mo, 18mo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Baseline through month 18
Arm/Group Title	Weight Loss + Exercise + Sitless		Weight Loss + Sitless		Weight Loss + Exercise
Arm/Group Description	Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).		Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).		Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
All Cause Mortality
	Weight Loss + Exercise + Sitless		Weight Loss + Sitless		Weight Loss + Exercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/63 (0%)		0/60 (0%)
Serious Adverse Events
	Weight Loss + Exercise + Sitless		Weight Loss + Sitless		Weight Loss + Exercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/60 (13.3%)		7/63 (11.1%)		4/60 (6.7%)
Cardiac disorders
Atrial Fibrillation	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Chest Pain	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Myocardial Infarction	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Pericarditis	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Takatsubu cardiomyopathy	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Chest Pain	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Gastrointestinal disorders
Gastritis	2/60 (3.3%)	2	0/63 (0%)	0	0/60 (0%)	0
Injury, poisoning and procedural complications
fall	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Complication of laparoscopic banding	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
fall	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Adrenal benign mass	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Nervous system disorders
Post Viral Neuropathy	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Brain aneurysm	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Surgical and medical procedures
Coronary artery bypass graft	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Gastric sleeve procedure	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Knee replacement	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Hysterectomy	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Other (Not Including Serious) Adverse Events
	Weight Loss + Exercise + Sitless		Weight Loss + Sitless		Weight Loss + Exercise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	39/60 (65%)		26/63 (41.3%)		25/60 (41.7%)
Cardiac disorders
Atrial Fibrillation	2/60 (3.3%)	2	0/63 (0%)	0	0/60 (0%)	0
Chest Pain	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Myocardial Infarction	0/60 (0%)	0	1/63 (1.6%)	1	1/60 (1.7%)	1
hypertension	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Aneurysm	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Pericarditis	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Pericardial effusion	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Takatsubu cardiomyopathy	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Cardiac Arrest	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Chest Pain	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Ear and labyrinth disorders
Vertigo	2/60 (3.3%)	2	2/63 (3.2%)	2	2/60 (3.3%)	2
Middle ear inflammation	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Eustachian tube infection	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Hearing impaired	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
retinal vascular disorder	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Eye disorders
cataracts	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Conjunctivitis	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Gastrointestinal disorders
Nausea	4/60 (6.7%)	4	0/63 (0%)	0	0/60 (0%)	0
Abdominal Pain	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Esophageal Pain	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Irritable Bowel Syndrome	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Ulcerative colitis	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Gastritis	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Small intestinal obstruction	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Hemorrhoids	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Gastroenteritis	0/60 (0%)	0	2/63 (3.2%)	2	0/60 (0%)	0
Gallbladder pain	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
General disorders
Dehydration	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Fatigue	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Fever	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Immune system disorders
allergic reaction	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Infections and infestations
Upper respiratory infection	2/60 (3.3%)	3	2/63 (3.2%)	2	1/60 (1.7%)	1
Bronchial infection	5/60 (8.3%)	6	2/63 (3.2%)	2	2/60 (3.3%)	2
Influenza	4/60 (6.7%)	4	1/63 (1.6%)	1	3/60 (5%)	3
Sinusitis	2/60 (3.3%)	2	0/63 (0%)	0	2/60 (3.3%)	3
Lung infection	2/60 (3.3%)	2	0/63 (0%)	0	0/60 (0%)	0
Nail infection	1/60 (1.7%)	1	1/63 (1.6%)	1	0/60 (0%)	0
Bacterial gastroenteritis	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Herpes zoster	2/60 (3.3%)	2	0/63 (0%)	0	0/60 (0%)	0
Skin infection	1/60 (1.7%)	1	1/63 (1.6%)	1	0/60 (0%)	0
Tooth infection	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Vaginal infection (fungal)	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Viral infection	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Prostate infection	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Lyme disease	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Injury, poisoning and procedural complications
Fall	2/60 (3.3%)	2	4/63 (6.3%)	5	2/60 (3.3%)	2
Fall	2/60 (3.3%)	2	3/63 (4.8%)	5	0/60 (0%)	0
Fracture	1/60 (1.7%)	1	1/63 (1.6%)	1	1/60 (1.7%)	1
fracture	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Ankle sprain	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Foot injury	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Complication of laparoscopic banding	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Car/Motor vehicle accident	1/60 (1.7%)	2	0/63 (0%)	0	0/60 (0%)	0
Car/Motor vehicle accident	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Vaccine reaction	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Medication Side Effect	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Concussion	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Musculoskeletal and connective tissue disorders
Back Pain	5/60 (8.3%)	5	2/63 (3.2%)	3	3/60 (5%)	3
Arthralgia	4/60 (6.7%)	5	3/63 (4.8%)	3	3/60 (5%)	5
Pain in extremity	2/60 (3.3%)	2	0/63 (0%)	0	1/60 (1.7%)	2
Arthritis	2/60 (3.3%)	2	1/63 (1.6%)	1	0/60 (0%)	0
Bone Pain	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Muscle weakness lower limb	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Myalgia	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Capsulitis	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Muscle Strain	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Achilles tendonitis	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Knee sprain	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Plantar Fasciitis	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Ankle Sprain	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Hip Pain	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Back Pain	1/60 (1.7%)	1	0/63 (0%)	0	1/60 (1.7%)	1
Arthralgia	0/60 (0%)	0	1/63 (1.6%)	1	4/60 (6.7%)	4
Gout	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
TMJ pain	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Dental Crown Replacement	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Lung cancer	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Retro-peritoneal mass	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Uterine cancer	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Basal cell skin cancer	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Adrenal benign mass	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Nervous system disorders
Headache	1/60 (1.7%)	1	0/63 (0%)	0	1/60 (1.7%)	1
Presyncope	1/60 (1.7%)	2	0/63 (0%)	0	0/60 (0%)	0
Dizziness	0/60 (0%)	0	0/63 (0%)	0	2/60 (3.3%)	2
Neuralgia	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Paresthesia	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Radiculitis	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Vasovagal reaction	1/60 (1.7%)	2	0/63 (0%)	0	0/60 (0%)	0
Multiple sclerosis	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Stenosis of branch of left middle cerebral	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Parkinson's disease	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Light headed	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Post viral neuropathy	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Brain aneurysm	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Renal and urinary disorders
Hematuria	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Renal calculi	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction	1/60 (1.7%)	1	1/63 (1.6%)	1	0/60 (0%)	0
Cough	1/60 (1.7%)	1	0/63 (0%)	0	1/60 (1.7%)	1
Allergic rhinitis	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Dyspnea	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Dyspnea	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Pulmonary embolism	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Skin and subcutaneous tissue disorders
Erythroderma	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Contact dermatitis	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Cyst	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Surgical and medical procedures
Hip replacement	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Bilateral blepharoplasty	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Carpal tunnel surgery	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Carpal tunnel surgery	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Cataract surgery	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Cataract surgery	0/60 (0%)	0	1/63 (1.6%)	2	0/60 (0%)	0
Coronary artery bypass graft	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0
Epidural injection	1/60 (1.7%)	1	0/63 (0%)	0	1/60 (1.7%)	1
Excision of skin cancers	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Gastric sleeve procedure	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Joint injection	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Saphenous vein ablation	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Phlebotomy	0/60 (0%)	0	0/63 (0%)	0	1/60 (1.7%)	1
Knee replacement	0/60 (0%)	0	2/63 (3.2%)	2	0/60 (0%)	0
Hernia repair	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Achilles tendon repair	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Removal of ingrown toe nail	1/60 (1.7%)	1	0/63 (0%)	0	0/60 (0%)	0
Hysterectomy	0/60 (0%)	0	1/63 (1.6%)	1	0/60 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.