WE Project: 2.0 Grassroots Wellness Coaching (Phase 2)

July 9, 2026 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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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. 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). HCL will recruit members of their social network (>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 adiposity (weight and waist circumference), other cardiometabolic risk factors (e.g., fasting glucose) and behavioral risk factors (physical activity and diet quality). In addition, the investigators will employ a mixed methods approach (process data, surveys, in-depth interviews with HCL, participants and key stakeholders) to assess factors that might promote and / or interfere with sustainability over long-term follow up to inform our future clinical trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 following the 24-week assessment.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants.
Time Frame: 12 week and 24 weeks post-treatment
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.
Time Frame: 12 week and 24 weeks post-treatment
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.
Time Frame: 12 week and 24 weeks post-treatment
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.
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 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.
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 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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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