WE Project: 2.0 Grassroots Wellness Coaching (Phase 2)
2 other identifiers
interventional
42
1 country
1
Brief Summary
African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The treatment program being tested in this research study aims to address these factors and improve cardiometabolic health outcomes for the study population. The purpose of this research study is to find out about the feasibility, acceptability and preliminary effectiveness of using house chats (HC) as a model for a weight management program in a real-world, community-based setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2023
CompletedStudy Start
First participant enrolled
November 28, 2023
CompletedFirst Posted
Study publicly available on registry
December 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2025
CompletedJuly 13, 2026
October 1, 2025
1.7 years
November 9, 2023
July 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants.
Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants.
12 week and 24 weeks post-treatment
Participants in the intervention will manifest clinically significant improvements in waist circumference with a signal for differential benefit compared to delayed intervention participants.
Waist circumference will be measured using a Gulik tape measure at the midpoint between the highest point of the iliac crest and the lowest part of the costal margin in the mid-axillary line.
12 week and 24 weeks post-treatment
Participants will experience clinically significant improvements in fasting glucose with a signal for differential benefit compared to delayed intervention participants.
Finger-prick blood sample via a point-of-care Accu-Check glucometer will be used to obtain fasting glucose.
12 week and 24 weeks post-treatment
Participants in the intervention will manifest clinically significant change in physical activity outcomes targeted in the intervention.
Physical activity will be objectively assessed via accelerometers. Total minutes of physical activity is the main outcome, but we will also examine minutes of light and moderate-to-vigorous physical activity. The threshold for clinically meaningful is 150 minutes / week which is consistent with a wealth of evidence and current evidence-based guidelines.
12 week and 24 weeks post-treatment
Participants in the intervention ward will manifest clinically significant improvements in dietary quality outcomes targeted in the intervention.
The EARLY Trials 4-item Sugar Sweetened Beverage Questionnaire and 10-item NCI fruit and vegetable screener (all day version) to assess changes in core intervention targets will be administered. While any changes improvements in these outcomes would be meaningful if sustained over time, the results we will also will compare to current American Heart Association guidelines / recommendations
12 week and 24 weeks post-treatment
Study Arms (2)
Intervention
EXPERIMENTALParticipants will be randomized to intervention and will receive the 12-week program.
Delayed Intervention Control
ACTIVE COMPARATORParticipants will be randomized to delayed intervention control and will receive the same 12-week program following the 24-week assessment.
Interventions
A 12-week lifestyle intervention delivered via weekly group meetings in the House Chat Leaders (HCL's) homes
Eligibility Criteria
You may qualify if:
- or older
- Resident of Petersburg, VA
You may not qualify if:
- Dx of type 1 diabetes mellitus
- Current treatment for cancer
- Medical conditions that may increase risk for participating in unsupervised physical activity unless medical provider provides consent for participation
- Hospitalization for depression or other psychiatric disorder within the past 12 months
- Uncontrolled psychotic disorder or bipolar disorder
- Currently pregnant or lactating or planning to become pregnant within the study period
- Current involvement in a weight loss program or current use of weight loss medication
- Inability to speak and read English
- Planning to move from the Petersburg area within the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moghboeba Mosavel
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Four wards will be randomly assigned to either intervention or a delayed intervention control. A total of 10 HCL will be recruited and trained across the two wards (5 in the intervention ward and 5 in delayed intervention ward).
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2023
First Posted
December 15, 2023
Study Start
November 28, 2023
Primary Completion
July 30, 2025
Study Completion
July 30, 2025
Last Updated
July 13, 2026
Record last verified: 2025-10