This study seeks to establish the efficacy of identifying weight loss nonresponders early in a Diabetes Prevention Program (DPP) intervention in 20 community settings (primarily churches and community centers) and providing them with individual-level, enhanced treatment through telephone contacts and access to additional resources. Additionally, potential mediators and moderators of the relationship between intervention status and weight loss response at 6 months in both nonresponders and responders will be examined and a cost-effectiveness analysis to evaluate the cost of the intervention will be conducted. This study addresses key gaps in the literature about the weight loss effects of identifying nonresponders early and characterizing individuals who need more intense personalized strategies. The investigators hypothesize that changes between baseline and 3 months will be more pronounced among the nonresponders in the intervention group compared to the nonresponders in the active control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
403
The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
First Corinthian Baptist Church
Frankfort, Kentucky, United States
Heavenly Outpour
Frankfort, Kentucky, United States
Consolidated Baptist Church
Lexington, Kentucky, United States
Historic St. Paul AME Church
Lexington, Kentucky, United States
First African Baptist Church
Lexington, Kentucky, United States
Pilgrim Baptist Church
Lexington, Kentucky, United States
Shiloh Baptist Church
Lexington, Kentucky, United States
Redeemed Christian Church of God
Lexington, Kentucky, United States
First Baptist Church Brackstown
Lexington, Kentucky, United States
Lima Drive Seventh Day Adventist Church
Lexington, Kentucky, United States
...and 11 more locations
Change in Weight at 12 Weeks
Weight will be measured in pounds using a cellular scale at baseline and at 12 weeks.
Time frame: 12 weeks (at baseline and12 weeks)
Change in Weight at 6 Months
Weight will be measured in pounds using a cellular scale at baseline and at 6 months.
Time frame: 6 months (at baseline and 6 months)
Change in Blood Pressure at 12 Weeks
Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 12 weeks.
Time frame: 12 weeks (at baseline and 12 weeks)
Change in Blood Pressure at 6 Months
Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 6 months.
Time frame: 6 months (at baseline and 6 months)
Change in Physical Activity at 12 Weeks
Change in Physical Activity will be measured at baseline and 12-week using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration across the leisure and occupational components. Responses were converted to metabolic equivalent hours per week (MET-hrs/week) using standard scoring procedures, where higher MET-hrs/week indicates greater physical activity.
Time frame: 12 weeks (at baseline and 12 weeks)
Change in Physical Activity at 6 Months
Change in Physical Activity will be measured at baseline and 6-month using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration across the leisure and occupational components. Responses were converted to metabolic equivalent hours per week (MET-hrs/week) using standard scoring procedures, where higher MET-hrs/week indicates greater physical activity.
Time frame: 6 months (at baseline and 6 months)
Change in Dietary Intake at 12 Weeks
Change in Dietary Intake will be measured using the validated, Dana Farber eating habits tool and the Dietary screener questionnaire which assesses the frequency of consumption of selected foods and drinks. The scoring range of the survey is Never or less than once per month, 1-3 per month, 1 per week, 2-4 per week, 5-6 per week, 1 per day, 2-3 per day, 4-5 per day, 6 or more per day, Prefer not to answer. Higher scores indicated increased dietary intake. The total score is the sum of the scores on all items, divided by the total maximum score possible, and then multiplied by 100.
Time frame: 12 weeks (at baseline and 12 weeks)
Change in Dietary Intake at 6 Months
Change in Dietary Intake will be measured using the validated, Dana Farber eating habits tool and the Dietary screener questionnaire which assesses the frequency of consumption of selected foods and drinks. The scoring range of the survey is Never or less than once per month, 1-3 per month, 1 per week, 2-4 per week, 5-6 per week, 1 per day, 2-3 per day, 4-5 per day, 6 or more per day, Prefer not to answer. Higher scores indicated increased dietary intake.The total score is the sum of the scores on all items, divided by the total maximum score possible, and then multiplied by 100.
Time frame: 6 months (at baseline, 12 weeks, 6 months)
Cost Analysis
Investigator-developed instrument. At 6 months, conduct a cost-effectiveness analysis to evaluate the cost of the intervention arm by comparing the incremental cost and weight loss with the active control arm. The generated final output is the cost per participant in dollars.
Time frame: 6 months
Impact of Weight on Quality of Life
Quality of life will be measured using Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite). This is a 31-item self-report scale. Scores range from 0-100; higher scores indicate greater quality of life.
Time frame: 6 months
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