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Completed

NCT Number: NCT06172582

WE Project: 2.0 Grassroots Wellness Coaching (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.

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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

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

12-week lifestyle intervention

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

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

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 15, 2023
Registry last updated
Jul 13, 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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