WE Project: 2.0 Grassroots Wellness Coaching (Phase 2)

Obesity Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT06172582
• Study type: Interventional
• Source: Virginia Commonwealth University
• Contact: Morgan Meyer
• Phone: (804) 827-2250
• Email: morgan.meyer@vcuhealth.org
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2023
• Completion date: March 1, 2025