WE Project: 2.0 Grassroots Wellness Coaching (Phase 2)

NCT ID: NCT06172582

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-28
• Study Completion Date: 2025-07-30

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 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.

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.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

Participants will be randomized to intervention and will receive the 12-week program.

Group Type: EXPERIMENTAL

12-week lifestyle intervention

Intervention Type: BEHAVIORAL

A 12-week lifestyle intervention delivered via weekly group meetings in the House Chat Leaders (HCL's) homes

Delayed Intervention Control

Participants will be randomized to delayed intervention control and will receive the same 12-week program.

Group Type: ACTIVE_COMPARATOR

12-week lifestyle intervention

Intervention Type: BEHAVIORAL

A 12-week lifestyle intervention delivered via weekly group meetings in the House Chat Leaders (HCL's) homes

Interventions

12-week lifestyle intervention

A 12-week lifestyle intervention delivered via weekly group meetings in the House Chat Leaders (HCL's) homes

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moghboeba Mosavel

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DK132373

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20024014 Phase 2

Identifier Type: -

Identifier Source: org_study_id