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

Primary Purpose

Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DPP-GLB Standard
DPP-GLB Enhanced
Sponsored by
Lovoria Williams
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring prevention, weight loss, community, personalized, telephone, resources, lifestyle intervention, racial ethnic minorities / African American, faith based, obesity, non-responders, adults, cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • First Corinthian Baptist Church
  • Heavenly Outpour
  • Consolidated Baptist Church
  • Historic St. Paul AME Church
  • First African Baptist Church
  • Pilgrim Baptist Church
  • Shiloh Baptist Church
  • Redeemed Christian Church of GodRecruiting
  • First Baptist Church Brackstown
  • Lima Drive Seventh Day Adventist Church
  • Bates Memorial Baptist Church
  • St. Stephen Baptist Church
  • Historic Calvary MBC
  • Forest Baptist Church
  • Burnett Ave BC
  • First Baptist Winchester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DPP-GLB Standard

DPP-GLB Enhanced

Arm Description

Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.

Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.

Outcomes

Primary Outcome Measures

Change in Weight at 12 Weeks
Weight will be measured in pounds using a cellular scale at baseline and at 12 weeks.
Change in Weight at 6 Months
Weight will be measured in pounds using a cellular scale at baseline and at 6 months.

Secondary Outcome Measures

Change in Blood Pressure at 12 Weeks
Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 28, 2021
Last Updated
July 5, 2023
Sponsor
Lovoria Williams
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04757519
Brief Title
Enhanced DPP-GLB to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.
Official Title
Enhancing the Diabetes Prevention Program to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2021 (Actual)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lovoria Williams
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
prevention, weight loss, community, personalized, telephone, resources, lifestyle intervention, racial ethnic minorities / African American, faith based, obesity, non-responders, adults, cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DPP-GLB Standard
Arm Type
Experimental
Arm Description
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
Arm Title
DPP-GLB Enhanced
Arm Type
Experimental
Arm Description
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
Intervention Type
Behavioral
Intervention Name(s)
DPP-GLB Standard
Intervention Description
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 Type
Behavioral
Intervention Name(s)
DPP-GLB Enhanced
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Weight at 12 Weeks
Description
Weight will be measured in pounds using a cellular scale at baseline and at 12 weeks.
Time Frame
12 weeks (at baseline and12 weeks)
Title
Change in Weight at 6 Months
Description
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)
Secondary Outcome Measure Information:
Title
Change in Blood Pressure at 12 Weeks
Description
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)
Title
Change in Blood Pressure at 6 Months
Description
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)
Title
Change in Physical Activity at 12 Weeks
Description
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.
Time Frame
12 weeks (at baseline and 12 weeks)
Title
Change in Physical Activity at 6 Months
Description
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.
Time Frame
6 months (at baseline and 6 months)
Title
Change in Dietary Intake at 12 Weeks
Description
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.
Time Frame
12 weeks (at baseline and 12 weeks)
Title
Change in Dietary Intake at 6 Months
Description
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.
Time Frame
6 months (at baseline, 12 weeks, 6 months)
Title
Cost Analysis
Description
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.
Time Frame
6 months
Title
Impact of Weight on Quality of Life
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lovoria Williams
Phone
859-323-5579
Email
lovoria.williams@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Karle
Phone
859-323-6105
Email
erika.karle@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lovoria Williams
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Corinthian Baptist Church
City
Frankfort
State/Province
Kentucky
ZIP/Postal Code
40601
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Heavenly Outpour
City
Frankfort
State/Province
Kentucky
ZIP/Postal Code
40601
Country
United States
Individual Site Status
Completed
Facility Name
Consolidated Baptist Church
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40505
Country
United States
Individual Site Status
Completed
Facility Name
Historic St. Paul AME Church
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40507
Country
United States
Individual Site Status
Completed
Facility Name
First African Baptist Church
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States
Individual Site Status
Completed
Facility Name
Pilgrim Baptist Church
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States
Individual Site Status
Completed
Facility Name
Shiloh Baptist Church
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Redeemed Christian Church of God
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adebola Adegboyega
Facility Name
First Baptist Church Brackstown
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40511
Country
United States
Individual Site Status
Completed
Facility Name
Lima Drive Seventh Day Adventist Church
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40511
Country
United States
Individual Site Status
Completed
Facility Name
Bates Memorial Baptist Church
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40203
Country
United States
Individual Site Status
Completed
Facility Name
St. Stephen Baptist Church
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40210
Country
United States
Individual Site Status
Completed
Facility Name
Historic Calvary MBC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40211
Country
United States
Individual Site Status
Completed
Facility Name
Forest Baptist Church
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40218
Country
United States
Individual Site Status
Completed
Facility Name
Burnett Ave BC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Individual Site Status
Completed
Facility Name
First Baptist Winchester
City
Winchester
State/Province
Kentucky
ZIP/Postal Code
40391
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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