Clinical trial NCT04757519: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes
Keywords: prevention
weight loss
community
personalized
telephone
resources
lifestyle intervention
racial ethnic minorities / African American
faith based
obesity
non-responders
adults
cancer
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-02-17
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Weight at 12 Weeks
timeFrame: 12 weeks (at baseline and12 weeks)
measure: Change in Weight at 6 Months
timeFrame: 6 months (at baseline and 6 months)
Secondary outcomes:
measure: Change in Blood Pressure at 12 Weeks
timeFrame: 12 weeks (at baseline and 12 weeks)
measure: Change in Blood Pressure at 6 Months
timeFrame: 6 months (at baseline and 6 months)
measure: Change in Physical Activity at 12 Weeks
timeFrame: 12 weeks (at baseline and 12 weeks)
measure: Change in Physical Activity at 6 Months
timeFrame: 6 months (at baseline and 6 months)
measure: Change in Dietary Intake at 12 Weeks
timeFrame: 12 weeks (at baseline and 12 weeks)
measure: Change in Dietary Intake at 6 Months
timeFrame: 6 months (at baseline, 12 weeks, 6 months)
measure: Cost Analysis
timeFrame: 6 months
measure: Impact of Weight on Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Frankfort
country: United States
facility: First Corinthian Baptist Church
state: Kentucky
city: Frankfort
country: United States
facility: Heavenly Outpour
state: Kentucky
city: Lexington
country: United States
facility: Consolidated Baptist Church
state: Kentucky
city: Lexington
country: United States
facility: Historic St. Paul AME Church
state: Kentucky
city: Lexington
country: United States
facility: First African Baptist Church
state: Kentucky
city: Lexington
country: United States
facility: Pilgrim Baptist Church
state: Kentucky
city: Lexington
country: United States
facility: Shiloh Baptist Church
state: Kentucky
city: Lexington
country: United States
facility: Redeemed Christian Church of God
state: Kentucky
city: Lexington
country: United States
facility: First Baptist Church Brackstown
state: Kentucky
city: Lexington
country: United States
facility: Lima Drive Seventh Day Adventist Church
state: Kentucky
city: Louisville
country: United States
facility: Kingdom Fellowship
state: Kentucky
city: Louisville
country: United States
facility: Bates Memorial Baptist Church
state: Kentucky
city: Louisville
country: United States
facility: St. Stephen Baptist Church
state: Kentucky
city: Louisville
country: United States
facility: Greater Gaililee CDC
state: Kentucky
city: Louisville
country: United States
facility: Historic Calvary MBC
state: Kentucky
city: Louisville
country: United States
facility: Spirit Filled New Life Church
state: Kentucky
city: Louisville
country: United States
facility: Forest Baptist Church
state: Kentucky
city: Louisville
country: United States
facility: Burnett Ave BC
state: Kentucky
city: Shelbyville
country: United States
facility: Marnel C. Moorman Family Life Center
state: Kentucky
city: Shelbyville
country: United States
facility: New Mt. Zion Baptist Church
state: Kentucky
city: Winchester
country: United States
facility: First Baptist Winchester
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Lovoria Williams
role: PRINCIPAL_INVESTIGATOR
References: