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Completed

NCT Number: NCT05544708

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

African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The 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 delivering a weight-management program in a real-world, community-based setting.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

Wellness Ambassadors will undergo training to recruit and deliver a lifestyle intervention to members of their social networks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wellness Engagement Intervention

Behavioral

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

Primary outcomes

  1. Feasibility: House Chat Leaders (HCL)

    Time frame: 18 months

    House Chat Leaders (HCL) will undergo training to recruit and deliver a lifestyle intervention to members of their social networks.

  2. Feasibility: Participants

    Time frame: 18 months

    The total number of participants recruited by the HCLs. The pre-specified goal is 80 participants overall (approximately 8 per house chat). A total of 71 individuals were interested and completed initial pre-screening. Of those, 43 were eligible and consented to participate. One individual did not complete their baseline visit, leaving 42 participants randomization eligible.

  3. Feasibility: Delivery Model

    Time frame: 12 weeks

    The number of intervention sessions delivered as planned. The pre-specified threshold was 70% of sessions.

Secondary outcomes

  1. Acceptability: Attendance

    Time frame: 12 weeks

    The average number of sessions attended by participants. The pre-specified threshold was 70% of sessions.

  2. Acceptability: Retention

    Time frame: 12 weeks

    The percentage of participants who are retained in the program. The pre-specified target to demonstrate acceptability was 80% retention.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2022
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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