Trial Outcomes & Findings for The Pitt Retiree Study: A Diabetes Prevention Program for Medicare Eligible Older Adults (NCT NCT03192475)
NCT ID: NCT03192475
Last Updated: 2024-04-24
Results Overview
Bodyweight of participant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
322 participants
Primary outcome timeframe
Change from baseline bodyweight at 12-months
Results posted on
2024-04-24
Participant Flow
Participant milestones
| Measure |
GLB Plus Phone Contacts
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 Plus Newsletter Contacts
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.
|
|---|---|---|
|
Overall Study
STARTED
|
162
|
160
|
|
Overall Study
COMPLETED
|
149
|
151
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
Reasons for withdrawal
| Measure |
GLB Plus Phone Contacts
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 Plus Newsletter Contacts
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.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
13
|
8
|
Baseline Characteristics
The Pitt Retiree Study: A Diabetes Prevention Program for Medicare Eligible Older Adults
Baseline characteristics by cohort
| Measure |
GLB Plus Phone Contacts
n=162 Participants
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 Plus Newsletter Contacts
n=160 Participants
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
n=322 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
71.0 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
71.2 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
162 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
141 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
34.0 kilograms divided by meters squared
STANDARD_DEVIATION 5.6 • n=5 Participants
|
33.5 kilograms divided by meters squared
STANDARD_DEVIATION 5.1 • n=7 Participants
|
33.8 kilograms divided by meters squared
STANDARD_DEVIATION 5.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline bodyweight at 12-monthsPopulation: 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.
Bodyweight of participant.
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=156 Participants
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 Plus Newsletter Contacts
n=156 Participants
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.
|
|---|---|---|
|
Change in Bodyweight
|
-7.4 percent weight change
Interval -8.9 to -5.9
|
-6.1 percent weight change
Interval -8.6 to -3.6
|
SECONDARY outcome
Timeframe: Change from baseline circumference at 12-monthsPopulation: 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.
Waist circumference measured with a spring-loaded tape measure.
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=156 Participants
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 Plus Newsletter Contacts
n=156 Participants
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.
|
|---|---|---|
|
Change in Waist Circumference
|
-5.3 cm
Interval -6.4 to -4.2
|
-4.1 cm
Interval -6.8 to -1.4
|
SECONDARY outcome
Timeframe: Change from baseline level at 12-monthsPopulation: 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.
Total cholesterol (mg/dl) measured by finger-stick blood sample
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=156 Participants
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 Plus Newsletter Contacts
n=156 Participants
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.
|
|---|---|---|
|
Change in Fasting Total Cholesterol
|
-5.0 mg/dl
Interval -9.3 to -0.8
|
-1.5 mg/dl
Interval -11.8 to 8.8
|
SECONDARY outcome
Timeframe: Change from baseline level at 12-monthsPopulation: 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.
HDL-cholesterol (mg/dl) measured by finger-stick blood sample
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=156 Participants
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 Plus Newsletter Contacts
n=156 Participants
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.
|
|---|---|---|
|
Change in Fasting High-Density Lipoprotein (HDL) Cholesterol
|
4.8 mg/dl
Interval 3.2 to 6.4
|
2.9 mg/dl
Interval -1.1 to 6.9
|
SECONDARY outcome
Timeframe: Change from baseline level at 12-monthsPopulation: 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.
LDL-cholesterol (mg/dl) measured by finger-stick blood sample
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=156 Participants
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 Plus Newsletter Contacts
n=156 Participants
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.
|
|---|---|---|
|
Change in Fasting Low-Density Lipoprotein (LDL) Cholesterol
|
-5.8 mg/dl
Interval -9.8 to -1.9
|
-1.1 mg/dl
Interval -10.6 to 8.4
|
SECONDARY outcome
Timeframe: Change from baseline level at 12-monthsPopulation: 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.
Triglycerides (mg/dl) measured by fasting finger-stick sample
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=156 Participants
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 Plus Newsletter Contacts
n=156 Participants
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.
|
|---|---|---|
|
Change in Fasting Triglycerides
|
-20.1 mg/dl
Interval -28.2 to -12.1
|
-16.5 mg/dl
Interval -36.0 to 3.0
|
SECONDARY outcome
Timeframe: Change from baseline level at 12-monthsPopulation: 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.
Fasting glucose (mg/dl) measured by finger-stick sample
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=156 Participants
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 Plus Newsletter Contacts
n=156 Participants
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.
|
|---|---|---|
|
Change in Fasting Glucose
|
-2.3 mg/dl
Interval -3.6 to -0.9
|
-1.1 mg/dl
Interval -4.3 to 2.3
|
SECONDARY outcome
Timeframe: Change from baseline level at 12-monthsPopulation: 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.
Systolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=156 Participants
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 Plus Newsletter Contacts
n=156 Participants
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.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
-2.6 mmHg
Interval -5.2 to 0.004
|
-1.6 mmHg
Interval -8.0 to 4.7
|
SECONDARY outcome
Timeframe: Change from baseline value at 12 monthsPopulation: 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.
Diastolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=156 Participants
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 Plus Newsletter Contacts
n=156 Participants
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.
|
|---|---|---|
|
Change in Diastolic Blood Pressure (mmHg)
|
-3.5 mm/Hg
Interval -4.8 to -2.1
|
-2.1 mm/Hg
Interval -5.4 to 1.2
|
SECONDARY outcome
Timeframe: Change from baseline score at 12-monthsPopulation: 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.
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.
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=156 Participants
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 Plus Newsletter Contacts
n=156 Participants
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.
|
|---|---|---|
|
Change in Physical Function Performance Battery
|
0.3 score on a scale
Standard Deviation 1.4
|
0.3 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Change from baseline minutes/week at 12-monthsPopulation: 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.
Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity questionnaire for older adults
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=155 Participants
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 Plus Newsletter Contacts
n=156 Participants
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.
|
|---|---|---|
|
Change in Physical Activity Minutes/Week Using All CHAMPS Items
|
30.0 minutes/week
Interval -165.0 to 300.0
|
30.0 minutes/week
Interval -225.0 to 323.0
|
SECONDARY outcome
Timeframe: percentage reporting higher intensity level activities 3 times per week or more at 12 monthsPopulation: 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.
Stanford Brief Physical Activity categorical measure: Queries amount and intensity of typical weekly activities over the past month. 1. most of week spent without any physical activity; sedentary at home; light chores; high intensity activities no more than 1-2 times per month. 2. most days of week spent doing few activities; 1-2 times per week some light-moderate activity like walking or active chores at home. 3. 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. 4. 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.
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=156 Participants
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 Plus Newsletter Contacts
n=155 Participants
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.
|
|---|---|---|
|
Percentage Participants Achieving 3 or More Days of Moderate Intensity Physical Activities Per Week
|
110 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: Change from baseline score at 12-monthsPopulation: 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.
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.
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=156 Participants
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 Plus Newsletter Contacts
n=156 Participants
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.
|
|---|---|---|
|
Change in Health Related Quality of Life-physical Component Summary Score
|
2.26 score on a scale
Standard Deviation 7.15
|
1.11 score on a scale
Standard Deviation 7.74
|
SECONDARY outcome
Timeframe: change from baseline score at 12-monthsPopulation: 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.
Mediterranean Diet Assessment Tool. Total score ranges from 0 - 14. A higher score means higher adherence to a better quality of diet.
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=156 Participants
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.
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Group Lifestyle Balance Plus Newsletter Contacts
n=156 Participants
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.
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|---|---|---|
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Change in Nutrition
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: change from baseline score at 12-monthsPopulation: 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.
Center for Epidemiological Studies Depression Scale (CES-D) (score ranges 0-60; higher score indicates greater depressive symptoms)
Outcome measures
| Measure |
Group Lifestyle Balance Plus Phone Contacts
n=155 Participants
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 Plus Newsletter Contacts
n=155 Participants
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.
|
|---|---|---|
|
Change in Mood
|
0.65 score on a scale
Standard Deviation 5.44
|
0.49 score on a scale
Standard Deviation 6.41
|
Adverse Events
GLB Plus Phone Contacts
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
GLB Plus Newsletter Contacts
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
GLB Plus Phone Contacts
n=162 participants at risk
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 Plus Newsletter Contacts
n=160 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
leg cellulitis
|
0.00%
0/162 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
0.62%
1/160 • Number of events 1 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
|
Musculoskeletal and connective tissue disorders
inguinal hernia
|
0.62%
1/162 • Number of events 1 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
0.00%
0/160 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
|
Vascular disorders
stroke
|
0.62%
1/162 • Number of events 1 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
0.62%
1/160 • Number of events 1 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
Other adverse events
| Measure |
GLB Plus Phone Contacts
n=162 participants at risk
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 Plus Newsletter Contacts
n=160 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
knee strain
|
0.62%
1/162 • Number of events 1 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
0.00%
0/160 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
|
Gastrointestinal disorders
constipation
|
0.62%
1/162 • Number of events 1 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
0.00%
0/160 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
|
Gastrointestinal disorders
gallstones
|
0.62%
1/162 • Number of events 1 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
0.00%
0/160 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
|
Musculoskeletal and connective tissue disorders
aggravated spinal stenosis
|
0.62%
1/162 • Number of events 1 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
0.00%
0/160 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
|
Musculoskeletal and connective tissue disorders
tendon tear from a fall
|
0.62%
1/162 • Number of events 1 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
0.00%
0/160 • Adverse event data collected throughout the entire length of the study, 0 - 24 months.
|
Additional Information
Elizabeth Mary Venditti PhD, Associate Professor of Psychiatry and Epidemiology
University of Pittsburgh
Phone: (412) 647-1027
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place