Enhanced DPP-GLB to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.

Diabetes Clinical Trial

Official title:

Enhancing the Diabetes Prevention Program to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04757519
• Other study ID #: 58766
• Secondary ID: 1R01DK125801-01
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: University of Kentucky
• Contact: Lovoria Williams
• Phone: 859-323-5579
• Email: lovoria.williams[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes
• Weight Loss

Intervention

Behavioral:
• DPP-GLB Standard
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.
• DPP-GLB Enhanced
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.

Locations

Country	Name	City	State
United States	First Corinthian Baptist Church	Frankfort	Kentucky
United States	Heavenly Outpour	Frankfort	Kentucky
United States	Consolidated Baptist Church	Lexington	Kentucky
United States	First African Baptist Church	Lexington	Kentucky
United States	First Baptist Church Brackstown	Lexington	Kentucky
United States	Historic St. Paul AME Church	Lexington	Kentucky
United States	Lima Drive Seventh Day Adventist Church	Lexington	Kentucky
United States	Pilgrim Baptist Church	Lexington	Kentucky
United States	Redeemed Christian Church of God	Lexington	Kentucky
United States	Shiloh Baptist Church	Lexington	Kentucky
United States	Bates Memorial Baptist Church	Louisville	Kentucky
United States	Burnett Ave BC	Louisville	Kentucky
United States	Forest Baptist Church	Louisville	Kentucky
United States	Greater Gaililee CDC	Louisville	Kentucky
United States	Historic Calvary MBC	Louisville	Kentucky
United States	Kingdom Fellowship	Louisville	Kentucky
United States	Spirit Filled New Life Church	Louisville	Kentucky
United States	St. Stephen Baptist Church	Louisville	Kentucky
United States	Marnel C. Moorman Family Life Center	Shelbyville	Kentucky
United States	First Baptist Winchester	Winchester	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Lovoria Williams	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight at 12 Weeks	Weight will be measured in pounds using a cellular scale at baseline and at 12 weeks.	12 weeks (at baseline and12 weeks)
Primary	Change in Weight at 6 Months	Weight will be measured in pounds using a cellular scale at baseline and at 6 months.	6 months (at baseline and 6 months)
Secondary	Change in Blood Pressure at 12 Weeks	Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 12 weeks.	12 weeks (at baseline and 12 weeks)
Secondary	Change in Blood Pressure at 6 Months	Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 6 months.	6 months (at baseline and 6 months)
Secondary	Change in Physical Activity at 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.	12 weeks (at baseline and 12 weeks)
Secondary	Change in Physical Activity at 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.	6 months (at baseline and 6 months)
Secondary	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.	12 weeks (at baseline and 12 weeks)
Secondary	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.	6 months (at baseline, 12 weeks, 6 months)
Secondary	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.	6 months
Secondary	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.	6 months