Enhanced DPP-GLB to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.
- Conditions
- Diabetes
- Interventions
- Behavioral: DPP-GLB StandardBehavioral: DPP-GLB Enhanced
- Registration Number
- NCT04757519
- Lead Sponsor
- Lovoria Williams
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 403
- self-described as Black
- non-diabetic
- body mass index (BMI) equal to or greater than 25
- CDC diabetes risk assessment greater than or equal to 5 or diabetes pre-diagnosis or history of gestational diabetes
- live within driving distance of participating church/site
- diagnosed Type 1 or 2 diabetes
- pregnant or planning to become pregnant during study period
- contraindications to moderate physical activity
- serious medical condition that contradicts weight loss
- not Black or African American
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DPP-GLB Standard DPP-GLB Standard Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program. DPP-GLB Enhanced DPP-GLB Enhanced Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
- Primary Outcome Measures
Name Time Method Change in Weight at 6 Months 6 months (at baseline and 6 months) Weight will be measured in pounds using a cellular scale at baseline and at 6 months.
Change in Weight at 12 Weeks 12 weeks (at baseline and12 weeks) Weight will be measured in pounds using a cellular scale at baseline and at 12 weeks.
- Secondary Outcome Measures
Name Time Method Change in Blood Pressure at 6 Months 6 months (at baseline and 6 months) Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 6 months.
Change in Dietary Intake at 12 Weeks 12 weeks (at baseline and 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.
Change in Physical Activity at 6 Months 6 months (at baseline and 6 months) Change in Physical Activity will be measured at baseline and 6 months using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration. Scoring is open-ended; higher scores indicate increased activity.
Change in Blood Pressure at 12 Weeks 12 weeks (at baseline and 12 weeks) Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 12 weeks.
Change in Physical Activity at 12 Weeks 12 weeks (at baseline and 12 weeks) Change in Physical Activity will be measured at baseline and 12 weeks using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration. Scoring is open-ended; higher scores indicate increased activity.
Change in Dietary Intake at 6 Months 6 months (at baseline, 12 weeks, 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.
Cost Analysis 6 months 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.
Impact of Weight on Quality of Life 6 months 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.
Trial Locations
- Locations (21)
Heavenly Outpour
🇺🇸Frankfort, Kentucky, United States
Consolidated Baptist Church
🇺🇸Lexington, Kentucky, United States
Shiloh Baptist Church
🇺🇸Lexington, Kentucky, United States
Redeemed Christian Church of God
🇺🇸Lexington, Kentucky, United States
Greater Gaililee CDC
🇺🇸Louisville, Kentucky, United States
Historic Calvary MBC
🇺🇸Louisville, Kentucky, United States
Forest Baptist Church
🇺🇸Louisville, Kentucky, United States
Burnett Ave BC
🇺🇸Louisville, Kentucky, United States
First Baptist Winchester
🇺🇸Winchester, Kentucky, United States
First Corinthian Baptist Church
🇺🇸Frankfort, 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
First Baptist Church Brackstown
🇺🇸Lexington, Kentucky, United States
Lima Drive Seventh Day Adventist Church
🇺🇸Lexington, Kentucky, United States
Kingdom Fellowship
🇺🇸Louisville, Kentucky, United States
Bates Memorial Baptist Church
🇺🇸Louisville, Kentucky, United States
St. Stephen Baptist Church
🇺🇸Louisville, Kentucky, United States
Spirit Filled New Life Church
🇺🇸Louisville, Kentucky, United States
Marnel C. Moorman Family Life Center
🇺🇸Shelbyville, Kentucky, United States
New Mt. Zion Baptist Church
🇺🇸Shelbyville, Kentucky, United States