WE Project: 2.0 Grassroots Wellness Coaching (Phase 2)

October 20, 2025 updated by: Virginia Commonwealth University

WE Project: 2.0 Grassroots Wellness Coaching. Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management (Phase 2)

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 increase outcomes for the study population. The purpose of this research study is to find out about the feasibility and acceptability of using house chats (HC) as a model for a weight loss program in a real-world, community-based setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The pilot trial will utilize a cluster randomized controlled design to assess the feasibility, acceptability, and preliminary effectiveness of the house chat model as a grassroots approach to lifestyle intervention delivery in a community setting. Two 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). HCL will recruit members of their social network (N=80, >18 years of age) to participate in a 12-week lifestyle intervention delivered via weekly group meetings in the HCL's homes. The primary goal is to understand the feasibility and acceptability of this novel approach to intervention delivery, and as such, process data on recruitment, training, fidelity of intervention delivery, and satisfaction with the sessions will be collected on a weekly basis. In addition, in-person assessment visits will take place at 0, 12 weeks (post-treatment) and 24 weeks (follow up) to determine the preliminary effectiveness of this intervention to promote positive changes on behavioral risk factors (physical activity and diet) and adiposity (weight and waist circumference). Satisfaction will be assessed in-person at 12 weeks (post-treatment) via surveys and an exit interview. In addition, The investigators will employ a mixed methods approach (process data, surveys, in-depth interviews with HCL and focus groups with participants) to assess factors that might promote and / or interfere with sustainability over long-term follow up to inform our future clinical trial.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants will be randomized to intervention and will receive the 12-week program.
Behavioral: 12-week lifestyle intervention
A 12-week lifestyle intervention delivered via weekly group meetings in the House Chat Leaders (HCL's) homes
Active Comparator: Delayed Intervention Control
Participants will be randomized to delayed intervention control and will receive the same 12-week program.
Behavioral: 12-week lifestyle intervention
A 12-week lifestyle intervention delivered via weekly group meetings in the House Chat Leaders (HCL's) homes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants in the intervention ward will manifest clinically significant change in physical activity outcomes targeted in the intervention.
Time Frame: 12 week and 24 weeks post-treatment
Physical activity will be objectively assessed via accelerometers. Total minutes of physical activity is the main outcome, but 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 Change in diet behavioral outcomes targeted in the intervention.
Time Frame: 12 week and 24 weeks post-treatment
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 in these outcomes would be meaningful if sustained over time, the results will compare to current guidelines / recommendations. Specifically, changing sugar intake no more than 9 teaspoons/36 grams/150 calories for men and 6 teaspoons/25 grams/100 calories for women per and increasing fruit and vegetable intake to at least 5 total servings per day are consistent with current guidelines.
12 week and 24 weeks post-treatment
Intervention ward participants will manifest clinically significant change in adiposity
Time Frame: 12 week and 24 weeks post-treatment
The thresholds for clinically meaningful will be different based on baseline weight status. For those without overweight or obesity staying within 1lb of baseline weight would be considered clinically meaningful. For absolute change in body mass index and percent change of initial body weight we will report the results stratified by weight status (BMI > 25 or BMI < 25) since weight management targets would be distinct for those with overweight / obesity vs. those classified as healthy weight (weight loss vs. weight gain prevention, respectively).] Weight will be measured with the Tanita BWB 800 digital portable scale . BMI will be calculated using the obtained weight and height measurements. Weight will be measured with the scale noted above and height will be measure via the Seca 213 portable stadiometer. Then, we will calculate BMI using the body mass index (kg/m2) = (average weight in kg) / (average height in m)2.
12 week and 24 weeks post-treatment
Subjects will manifest clinically significant change in Secondary markers of cardiometabolic risk through changed blood pressure readings
Time Frame: 12 week and 24 weeks post-treatment
Clinically significant changes in blood pressure include a systolic blood pressure (SBP) changing ≥ 10mmHg or a diastolic blood pressure (DBP) changing ≥ 5mmHg as this can change the category that a participant's blood pressure is categorized as. Please see the table below from AHA for reference. We will measure blood pressure using the GE Carescape V100 Monitor and Gulick II Tape Measure.
12 week and 24 weeks post-treatment
Subjects will manifest clinically significant change in secondary markers of cardiometabolic risk with changed Fasting Glucose Values
Time Frame: 12 week and 24 weeks post-treatment
Fasting glucose values are categorized as within normal range (≤ 99 mg/dL), in prediabetes stage (100-125 mg/dL), or having diabetes (≥ 126 mg/dL). A change for those that are in the prediabetes or diabetes categories will include their follow up values decreasing, while for those that are found to be in the normal range at baseline we will want them to maintain. Fasting glucose will be measured using the ACCU-CHEK Inform II Meter and ACCU-CHEK Inform II Test Strips.
12 week and 24 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Moghboeba Mosavel, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2023

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 15, 2023

Study Record Updates

Last Update Posted (Estimated)

October 22, 2025

Last Update Submitted That Met QC Criteria

October 20, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20024014 Phase 2
  • 1R01DK132373 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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