Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes

Sponsor

University of Colorado, Denver (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03840733

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

59.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed as an observational trial. The objective of this study is to follow-up with participants 3 years after completion of an 18-month comprehensive behavioral weight loss intervention. Outcomes of interest include change in body weight, body composition, physical activity, energy intake, and sleep. In addition, investigators will explore the associations between current physical activity, sleep, and energy intake patterns and body weight regulation.

Condition or Disease	Intervention/Treatment	Phase
Obesity Weight Change, Body

Detailed Description

A total of 170 participants were initially enrolled in the comprehensive behavioral weight loss intervention.In this study, investigators will conduct a follow-up visit 3 years after the completion of the intervention. Only participants who completed the behavioral weight loss intervention will be enrolled in this study. Participants will undergo testing of body weight, body composition, physical activity patterns, energy intake patterns, sleep patterns, resting metabolic rate, and total daily energy expenditure.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes

Actual Study Start Date :

Jan 7, 2019

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Participants from NCT01985568 All subjects who previously enrolled in the Parent Study's behavioral weight loss intervention (NCT01985568).

Outcome Measures

Primary Outcome Measures

Weight Change [Baseline to 54 months]
Change in body weight (kg)
Weight Maintenance [18 months to 54 months]
Change in body weight (kg)
Fat Mass Change [Baseline to 54 months]
Change in Fat Mass (kg)
Fat Free Mass Change [Baseline to 54 months]
Change in Fat Free Mass (kg)
Fat Mass Maintenance [18 months to 54 months]
Change in Fat Mass (kg)
Fat Free Mass Maintenance [18 months to 54 months]
Change in Fat Free Mass (kg)

Secondary Outcome Measures

Change in Physical Activity Patterns [0, 6, 12, 18, 24, 54 month]
Physical activity patterns as measured by SenseWear armband (min/day)
Physical Activity Patterns [54 month]
Physical activity patterns as measured by ActivPAL, Actigraph (min/day)
Change in Sleep [0, 6, 12, 18, 24, 54 month]
Sleep patterns as measured by SenseWear armband (h/day)
Sleep Patterns [54 month]
Sleep patterns as measured by Actiwatch-2, ActivPAL, Actigraph (h/day)
Change in Energy Intake [0, 6, 12, 18, 54 month]
Energy Intake patterns as measured by 3 day food record (kcal/day
Energy Intake Patterns [54 month]
Energy Intake patterns as measured by 24 hour food recall and meallogger smartphone application (kcal/day)
Resting Metabolic Rate [54 month]
Resting metabolic rate as measured using indirect calorimetry (kcal/day)
Total Daily Energy Expenditure [54 month]
Total Daily Energy Expenditure as measured by doubly labeled water (kcal/day)
Physical Activity Energy Expenditure [54 month]
Physical Activity Energy Expenditure as measured by doubly labeled water (kcal/day)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Previous enrollment in standard behavioral weight loss intervention (NCT01985568)
Age 20-60 (This age range has been selected based upon the participants enrolled in the Parent Trial)
Capable and willing to give informed consent
Possess a smartphone to install and utilize the meal timing application
Capable and willing to wear the Actigraph, ActivPAL and Actiwatch-2 for 24 hours/day for 28 consecutive days
Willing to complete the Total Daily Energy Expenditure (TDEE) assessment which includes multiple urine collections and drinking stable water isotopes

Exclusion Criteria:

Being considered unsafe to participate as determined by the study physician (Dr. Catennaci)
New diagnosis of a medical condition (not observed in the Parent Trial) which may affect weight or energy metabolism (e.g. depression, CVD, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases)
Women who became pregnant after completing the Parent Trial
Current use or use within the last 6 months of prescription or over-the-counter medications known to affect appetite, weight, and sleep