PRS: The Pitt Retiree Study: A Diabetes Prevention Program for Medicare Eligible Older Adults
Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT03192475
Collaborator
(none)
322
2
51.9
Study Details
Study Description
Brief Summary
The Pitt Retiree Study (PRS) disseminates a novel, yet practical, diabetes prevention program among Medicare eligible adults in Western Pennsylvania. This study will provide 4, and 12 month outcome data (with a no treatment follow-up assessment at 24 months) to help determine whether a continued contact group telephone intervention is feasible and effective in enhancing health outcomes and physical functional ability in high risk adults (aged 65-80) with obesity and cardiometabolic risk factors .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
There is substantial evidence that overweight and obesity during late life (≥ 65 years of age) confers significant risk for type 2 diabetes and co-morbid conditions. Thus, there is growing concern about the public health consequences of increased incidence of type 2 diabetes in an aging United States population. Studies with high risk samples have shown that lifestyle interventions significantly reduce diabetes risk and that elders are particularly responsive, showing better weight loss and lower rates of diabetes development in comparison to younger individuals. However, although there have been program dissemination studies with mixed-age adult cohorts, few studies have focused specifically on persons ≥ 65 years of age or addressed the challenges of identifying workable platforms for delivering prevention programs to older adults. This application is based on the premise that offering an evidence-based lifestyle intervention to reduce risk for type 2 diabetes to retirees during the annual Medicare enrollment process presents an innovative, practical opportunity to reach eligible, high-risk adults. If shown to be feasible and effective, this program has strong potential for public health impact and medical cost-containment. Further, although clinical studies have emphasized the importance of continued contact over time in helping individuals extend the benefits of lifestyle interventions, there are no dissemination studies of which we are aware that have systematically documented the impact of continued monthly contacts after the initial intervention period. Thus, the overall aims of this application are to: 1. examine the feasibility and effectiveness of implementing the Group Lifestyle Balance 12-session program (GLB-12), an evidence-supported prevention program to mitigate diabetes risk, as part of the Medicare benefit offered to high risk retirees at a large public university, and; 2. evaluate the utility of continued telephone contact in enhancing treatment outcome at 12-months from baseline. Eligible participants will be 320 adults without diabetes, aged 65-80, with a BMI ≥ 27 and at least one additional cardiometabolic risk factor. All participants will receive the GLB-12 and then will be randomized to one of two continued contact protocols for the remaining one year of intervention, 8-sessions of continued small group contact by telephone (GLB-12 plus 8TC) or a newsletter control condition (GLB-12 plus NC). Program feasibility will be assessed by reporting enrollment, adherence and session completion rates, and satisfaction ratings in this delivery context. Effectiveness of the GLB-12 will be documented by reporting mean percent weight loss and the proportion of participants meeting ≥ 5% weight loss, a commonly accepted benchmark in translation studies known to be associated with favorable cardiometabolic outcomes at month 4. It also is hypothesized that GLB-12 plus 8TC, when compared to GLB-12 plus NC will be associated with more favorable anthropometric (weight, waist), cardiometabolic (glucose, blood pressure, lipid), physical function (chair stand, balance, gait speed) and health related quality of life outcomes at months 12 and 24. Finally, exploratory analyses will document program costs and program impact on medical utilization.
Study Design
Study Type:
Interventional
Actual Enrollment
:
322 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
An initial (non-randomized) translational Group Lifestyle Balance (GLB) in person, lifestyle intervention designed to mitigate cardiometabolic risk in older adults is delivered to all participants between 0 and 4-months. Subsequently, one-half of the enrolled sample is randomized to either (1) 8-group telephone contacts (8-TC) for the remainder of 12-months; the other one-half is randomized to a newsletter control condition (NC) during this time period.An initial (non-randomized) translational Group Lifestyle Balance (GLB) in person, lifestyle intervention designed to mitigate cardiometabolic risk in older adults is delivered to all participants between 0 and 4-months. Subsequently, one-half of the enrolled sample is randomized to either (1) 8-group telephone contacts (8-TC) for the remainder of 12-months; the other one-half is randomized to a newsletter control condition (NC) during this time period.
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Dissemination of a Diabetes Prevention Program Among Medicare Eligible Older Adults
Actual Study Start Date
:
Jan 28, 2013
Actual Primary Completion Date
:
May 26, 2017
Actual Study Completion Date
:
May 26, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group Lifestyle Balance plus phone contacts Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months |
Behavioral: GLB plus phone contacts
GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving.
|
| Placebo Comparator: Group Lifestyle Balance plus newsletter contacts Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. |
Behavioral: GLB plus newsletter contacts
GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only.
|
Outcome Measures
Primary Outcome Measures
- Change in Bodyweight [Change from baseline bodyweight at 12-months]
Bodyweight of participant.
Secondary Outcome Measures
- Change in Waist Circumference [Change from baseline circumference at 12-months]
Waist circumference measured with a spring-loaded tape measure.
- Change in Fasting Total Cholesterol [Change from baseline level at 12-months]
Total cholesterol (mg/dl) measured by finger-stick blood sample
- Change in Fasting High-Density Lipoprotein (HDL) Cholesterol [Change from baseline level at 12-months]
HDL-cholesterol (mg/dl) measured by finger-stick blood sample
- Change in Fasting Low-Density Lipoprotein (LDL) Cholesterol [Change from baseline level at 12-months]
LDL-cholesterol (mg/dl) measured by finger-stick blood sample
- Change in Fasting Triglycerides [Change from baseline level at 12-months]
Triglycerides (mg/dl) measured by fasting finger-stick sample
- Change in Fasting Glucose [Change from baseline level at 12-months]
Fasting glucose (mg/dl) measured by finger-stick sample
- Change in Systolic Blood Pressure [Change from baseline level at 12-months]
Systolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)
- Change in Diastolic Blood Pressure (mmHg) [Change from baseline value at 12 months]
Diastolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)
- Change in Physical Function Performance Battery [Change from baseline score at 12-months]
Short Physical Performance Battery (SPPB) total score (0-12) includes three function tests (each scored 0-4) and summed. The subtests are (1) gait speed measured in meters/second on a 4-meter walk route; (2) 3 progressive standing balance tests; (3) 5 chair stands. Higher score indicates better physical function.
- Change in Physical Activity Minutes/Week Using All CHAMPS Items [Change from baseline minutes/week at 12-months]
Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity questionnaire for older adults
- Percentage Participants Achieving 3 or More Days of Moderate Intensity Physical Activities Per Week [percentage reporting higher intensity level activities 3 times per week or more at 12 months]
Stanford Brief Physical Activity categorical measure: Queries amount and intensity of typical weekly activities over the past month. most of week spent without any physical activity; sedentary at home; light chores; high intensity activities no more than 1-2 times per month. most days of week spent doing few activities; 1-2 times per week some light-moderate activity like walking or active chores at home. at least 3 times per week reports moderate activity such as brisk walking for 15-20 minutes or more, or at least 45-60 minutes of heavy home and yard chores. at least 3 times per week reports a regular program of moderate-vigorous intensity physical activities, or a regular program of fitness for 30 minutes or more, or active games like handball or tennis, or heavy home and yard chores for 60-minutes or more. Participants that endorse items 3 or 4 were considered to have achieved 3 or more days of moderate intensity physical activities per week.
- Change in Health Related Quality of Life-physical Component Summary Score [Change from baseline score at 12-months]
Short-form 12-item health status questionnaire produces two scores: a physical component summary score and a mental component summary score. Scores range from 0-100 with higher scores indicating better health related quality of life. Each component score is transformed (standardized) using a mean of 50 and a standard deviation of 10.
- Change in Nutrition [change from baseline score at 12-months]
Mediterranean Diet Assessment Tool. Total score ranges from 0 - 14. A higher score means higher adherence to a better quality of diet.
- Change in Mood [change from baseline score at 12-months]
Center for Epidemiological Studies Depression Scale (CES-D) (score ranges 0-60; higher score indicates greater depressive symptoms)
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Men and women, ages 65-80, with a BMI ≥ 27 and at least one of the following additional risk factors will be included: 1) Large waist circumference (> 40 inches men, >35 inches women) 2) hypertension or taking hypertension medication; 3) elevated lipids or taking medication for lipids or triglycerides 4) pre-diabetes (fasting glucose ≥ 100 mg/dL and < 126 mg/DL OR 5) or a score of 15 on the American Diabetes Association (ADA) risk test.
All study participants must have access to a telephone (including appropriate assistive devices if there are hearing impairments) and be able to read at the 6th grade level.
Exclusion Criteria:
-
Individuals who report that they have been diagnosed by their doctor with diabetes or that they are taking any medicines used to treat diabetes
-
lack of physician clearance for exercise participation before the 4th session
-
a weight loss of 4.5 kgs or more in the past six months (to rule out unintentional weight loss that may be an indicator of current or incipient physical illness)
-
current use of weight loss medications
-
unable to attend at least 75% of the GLB 12-session program or are unwilling to self-monitor food, activity and weight as prescribed will be excluded and encouraged to consider joining in subsequent years.
Excluded individuals are referred to other clinical resources as appropriate.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Pittsburgh
Investigators
- Principal Investigator: Elizabeth M Venditti, PhD, University of Pittsburgh
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Elizabeth Venditti,
Assistant Professor of Psychiatry and Epidemiology,
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03192475
Other Study ID Numbers:
- PRO12050022
First Posted:
Jun 20, 2017
Last Update Posted:
Nov 13, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | GLB Plus Phone Contacts | GLB Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | GLB is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months GLB plus phone contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | GLB is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. GLB plus newsletter contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Period Title: Overall Study | ||
| STARTED | 162 | 160 |
| COMPLETED | 149 | 151 |
| NOT COMPLETED | 13 | 9 |
Baseline Characteristics
| Arm/Group Title | GLB Plus Phone Contacts | GLB Plus Newsletter Contacts | Total |
|---|---|---|---|
| Arm/Group Description | GLB is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months GLB plus phone contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | GLB is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. GLB plus newsletter contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. | Total of all reporting groups |
| Overall Participants | 162 | 160 | 322 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
71.3
(4.4)
|
71.0
(4.2)
|
71.2
(4.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
126
77.8%
|
121
75.6%
|
247
76.7%
|
| Male |
36
22.2%
|
39
24.4%
|
75
23.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
3
1.9%
|
3
0.9%
|
| Not Hispanic or Latino |
162
100%
|
157
98.1%
|
319
99.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
21
13%
|
21
13.1%
|
42
13%
|
| White |
141
87%
|
139
86.9%
|
280
87%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Body Mass Index (BMI) (kilograms divided by meters squared) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kilograms divided by meters squared] |
34.0
(5.6)
|
33.5
(5.1)
|
33.8
(5.1)
|
Outcome Measures
| Title | Change in Bodyweight |
|---|---|
| Description | Bodyweight of participant. |
| Time Frame | Change from baseline bodyweight at 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in bodyweight at 12 months. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 156 | 156 |
| Mean (95% Confidence Interval) [percent weight change] |
-7.4
|
-6.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change in Waist Circumference |
|---|---|
| Description | Waist circumference measured with a spring-loaded tape measure. |
| Time Frame | Change from baseline circumference at 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the 12 month analysis of change in waist circumference. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 156 | 156 |
| Mean (95% Confidence Interval) [cm] |
-5.3
|
-4.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.15 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change in Fasting Total Cholesterol |
|---|---|
| Description | Total cholesterol (mg/dl) measured by finger-stick blood sample |
| Time Frame | Change from baseline level at 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in fasting total cholesterol at 12 months. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | GLB Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | GLB is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. GLB plus newsletter contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 156 | 156 |
| Mean (95% Confidence Interval) [mg/dl] |
-5.0
|
-1.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.25 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change in Fasting High-Density Lipoprotein (HDL) Cholesterol |
|---|---|
| Description | HDL-cholesterol (mg/dl) measured by finger-stick blood sample |
| Time Frame | Change from baseline level at 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these, 156 (96.3%) GLB plus phone contacts and 156 (97.5%) GLB plus newsletter contacts were included in the analysis of change in fasting high-density lipoprotein cholesterol at 12 months. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 156 | 156 |
| Mean (95% Confidence Interval) [mg/dl] |
4.8
|
2.9
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change in Fasting Low-Density Lipoprotein (LDL) Cholesterol |
|---|---|
| Description | LDL-cholesterol (mg/dl) measured by finger-stick blood sample |
| Time Frame | Change from baseline level at 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in fasting Low-Density Lipoprotein (LDL) at 12 months. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 156 | 156 |
| Mean (95% Confidence Interval) [mg/dl] |
-5.8
|
-1.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.09 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change in Fasting Triglycerides |
|---|---|
| Description | Triglycerides (mg/dl) measured by fasting finger-stick sample |
| Time Frame | Change from baseline level at 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in fasting triglycerides at 12 months. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 156 | 156 |
| Mean (95% Confidence Interval) [mg/dl] |
-20.1
|
-16.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.53 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change in Fasting Glucose |
|---|---|
| Description | Fasting glucose (mg/dl) measured by finger-stick sample |
| Time Frame | Change from baseline level at 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in fasting glucose at 12 months. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | GLB Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | GLB is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. GLB plus newsletter contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 156 | 156 |
| Mean (95% Confidence Interval) [mg/dl] |
-2.3
|
-1.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.21 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change in Systolic Blood Pressure |
|---|---|
| Description | Systolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC) |
| Time Frame | Change from baseline level at 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in systolic blood pressure at 12 months. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 156 | 156 |
| Mean (95% Confidence Interval) [mmHg] |
-2.6
|
-1.6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.60 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change in Diastolic Blood Pressure (mmHg) |
|---|---|
| Description | Diastolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC) |
| Time Frame | Change from baseline value at 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in diastolic blood pressure at 12 months. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 156 | 156 |
| Mean (95% Confidence Interval) [mm/Hg] |
-3.5
|
-2.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.15 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change in Physical Function Performance Battery |
|---|---|
| Description | Short Physical Performance Battery (SPPB) total score (0-12) includes three function tests (each scored 0-4) and summed. The subtests are (1) gait speed measured in meters/second on a 4-meter walk route; (2) 3 progressive standing balance tests; (3) 5 chair stands. Higher score indicates better physical function. |
| Time Frame | Change from baseline score at 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in the physical function performance battery at 12 months. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 156 | 156 |
| Mean (Standard Deviation) [score on a scale] |
0.3
(1.4)
|
0.3
(1.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change in Physical Activity Minutes/Week Using All CHAMPS Items |
|---|---|
| Description | Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity questionnaire for older adults |
| Time Frame | Change from baseline minutes/week at 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 155 (95.7%%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in physical activity minutes /per week at 12 months. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 155 | 156 |
| Median (Inter-Quartile Range) [minutes/week] |
30.0
|
30.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Percentage Participants Achieving 3 or More Days of Moderate Intensity Physical Activities Per Week |
|---|---|
| Description | Stanford Brief Physical Activity categorical measure: Queries amount and intensity of typical weekly activities over the past month. most of week spent without any physical activity; sedentary at home; light chores; high intensity activities no more than 1-2 times per month. most days of week spent doing few activities; 1-2 times per week some light-moderate activity like walking or active chores at home. at least 3 times per week reports moderate activity such as brisk walking for 15-20 minutes or more, or at least 45-60 minutes of heavy home and yard chores. at least 3 times per week reports a regular program of moderate-vigorous intensity physical activities, or a regular program of fitness for 30 minutes or more, or active games like handball or tennis, or heavy home and yard chores for 60-minutes or more. Participants that endorse items 3 or 4 were considered to have achieved 3 or more days of moderate intensity physical activities per week. |
| Time Frame | percentage reporting higher intensity level activities 3 times per week or more at 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these, 155 (95.7%%) GLB plus phone contacts and 156 (97.5%) GLB plus newsletter contacts were included in analysis of percentage reporting higher intensity activities 3 times per week or more. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 156 | 155 |
| Count of Participants [Participants] |
110
67.9%
|
81
50.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0009 |
| Comments | ||
| Method | Mantel Haenszel | |
| Comments | ||
| Title | Change in Health Related Quality of Life-physical Component Summary Score |
|---|---|
| Description | Short-form 12-item health status questionnaire produces two scores: a physical component summary score and a mental component summary score. Scores range from 0-100 with higher scores indicating better health related quality of life. Each component score is transformed (standardized) using a mean of 50 and a standard deviation of 10. |
| Time Frame | Change from baseline score at 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in health-related quality of life at 12 months. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 156 | 156 |
| Mean (Standard Deviation) [score on a scale] |
2.26
(7.15)
|
1.11
(7.74)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.18 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change in Nutrition |
|---|---|
| Description | Mediterranean Diet Assessment Tool. Total score ranges from 0 - 14. A higher score means higher adherence to a better quality of diet. |
| Time Frame | change from baseline score at 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in Mediterranean Diet score at 12 months. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 156 | 156 |
| Mean (Full Range) [score on a scale] |
1
|
1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.34 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change in Mood |
|---|---|
| Description | Center for Epidemiological Studies Depression Scale (CES-D) (score ranges 0-60; higher score indicates greater depressive symptoms) |
| Time Frame | change from baseline score at 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 155 (95.7%) of GLB plus phone contacts and 155 (96.9%) of GLB plus newsletter contacts were included in the analysis of change in health-related quality of life at 12 months. |
| Arm/Group Title | Group Lifestyle Balance Plus Phone Contacts | Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Arm/Group Description | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Group Lifestyle Balance plus phone contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Group Lifestyle Balance plus newsletter contacts: Group Lifestyle Balance is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. |
| Measure Participants | 155 | 155 |
| Mean (Standard Deviation) [score on a scale] |
0.65
(5.44)
|
0.49
(6.41)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Lifestyle Balance Plus Phone Contacts, Group Lifestyle Balance Plus Newsletter Contacts |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.82 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
Adverse Events
| Time Frame | Adverse event data collected throughout the entire length of the study, 0 - 24 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | GLB Plus Phone Contacts | GLB Plus Newsletter Contacts | ||
| Arm/Group Description | GLB is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months GLB plus phone contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | GLB is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. GLB plus newsletter contacts: GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. | ||
All Cause Mortality |
||||
| GLB Plus Phone Contacts | GLB Plus Newsletter Contacts | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/162 (0%) | 1/160 (0.6%) | ||
Serious Adverse Events |
||||
| GLB Plus Phone Contacts | GLB Plus Newsletter Contacts | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/162 (1.2%) | 2/160 (1.3%) | ||
| Infections and infestations | ||||
| leg cellulitis | 0/162 (0%) | 0 | 1/160 (0.6%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| inguinal hernia | 1/162 (0.6%) | 1 | 0/160 (0%) | 0 |
| Vascular disorders | ||||
| stroke | 1/162 (0.6%) | 1 | 1/160 (0.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| GLB Plus Phone Contacts | GLB Plus Newsletter Contacts | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/162 (3.1%) | 0/160 (0%) | ||
| Gastrointestinal disorders | ||||
| constipation | 1/162 (0.6%) | 1 | 0/160 (0%) | 0 |
| gallstones | 1/162 (0.6%) | 1 | 0/160 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| knee strain | 1/162 (0.6%) | 1 | 0/160 (0%) | 0 |
| aggravated spinal stenosis | 1/162 (0.6%) | 1 | 0/160 (0%) | 0 |
| tendon tear from a fall | 1/162 (0.6%) | 1 | 0/160 (0%) | 0 |
Limitations/Caveats
The study sample was predominantly white, female, middle-income and a single site study of urban and suburban communities in in southwestern Pennsylvania. Results may not generalize to other subgroups with high obesity-related health disparities.
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.
Results Point of Contact
| Name/Title | Elizabeth Mary Venditti PhD, Associate Professor of Psychiatry and Epidemiology |
|---|---|
| Organization | University of Pittsburgh |
| Phone | (412) 647-1027 |
| vendittiem@upmc.edu |
Responsible Party:
Elizabeth Venditti,
Assistant Professor of Psychiatry and Epidemiology,
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03192475
Other Study ID Numbers:
- PRO12050022
First Posted:
Jun 20, 2017
Last Update Posted:
Nov 13, 2019
Last Verified:
Oct 1, 2019