CompletedNot Applicable

WE Project: 2.0 Grassroots Wellness Coaching (Phase 2)

United States42 participantsStarted 2023-11-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 or older * Resident of Petersburg, VA Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants.

Timeframe: 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.

Timeframe: 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.

Timeframe: 12 week and 24 weeks post-treatment

Participants in the intervention will manifest clinically significant change in physical activity outcomes targeted in the intervention.

Timeframe: 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.

Timeframe: 12 week and 24 weeks post-treatment

Trial details

NCT IDNCT06172582

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-30

View on ClinicalTrials.gov More Obesity trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants.

Timeframe: 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.

Timeframe: 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.

Timeframe: 12 week and 24 weeks post-treatment

Participants in the intervention will manifest clinically significant change in physical activity outcomes targeted in the intervention.

Timeframe: 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.

Timeframe: 12 week and 24 weeks post-treatment