Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management

NCT ID: NCT05544708

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-05-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Wellness Ambassadors will undergo training to recruit and deliver a lifestyle intervention to members of their social networks. HCL in the intervention group will deliver the intervention immediately following baseline visits and randomization.

Group Type: EXPERIMENTAL

Wellness Engagement Intervention

Intervention Type: BEHAVIORAL

Train for, recruit participants into, and lead a 12-week lifestyle intervention delivered via weekly group meetings

Delayed Intervention

Wellness Ambassadors will undergo training to recruit and deliver a lifestyle intervention to members of their social networks. HCL in the delayed intervention group will deliver the intervention after 24 week data collection visits are complete.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wellness Engagement Intervention

Train for, recruit participants into, and lead a 12-week lifestyle intervention delivered via weekly group meetings

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18 and older
• Resident of Petersburg, VA
• Interested in engaging community members in healthy lifestyle changes (e.g., walking, small changes to eating) and willing to engage in these behaviors her/himself

Exclusion Criteria

• A diagnosis of type 1 diabetes mellitus.
• Currently being treated for cancer.
• Medical conditions that may increase risk for participating in unsupervised exercise, if medical clearance is not provided
• Hospitalization for depression or other psychiatric disorder within the past 12 months.
• Lifetime history of bipolar disorder or psychotic 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, read and write English.
• Planning to move from the Petersburg area within the study period.
• Does not have sufficient numbers of individuals in their social network from which to recruit for the proposed study.

• 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, PhD

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

Identifier Type: -

Identifier Source: org_study_id