WE Project: 2.0 Grassroots Wellness Coaching (Phase 2)

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: 12-week lifestyle intervention

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. 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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants will be randomized to intervention and will receive the 12-week program.	Behavioral: 12-week lifestyle intervention; A 12-week lifestyle intervention delivered via weekly group meetings in the House Chat Leaders (HCL's) homes
Active Comparator: Delayed Intervention Control; Participants will be randomized to delayed intervention control and will receive the same 12-week program following the 24-week assessment.	Behavioral: 12-week lifestyle intervention; A 12-week lifestyle intervention delivered via weekly group meetings in the House Chat Leaders (HCL's) homes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants.	Participants in the intervention will manifest clinically significant weight change with a signal for differential benefit compared to delayed intervention participants.	12 week and 24 weeks post-treatment
Participants in the intervention will manifest clinically significant improvements in waist circumference with a signal for differential benefit compared to delayed intervention participants.	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.	12 week and 24 weeks post-treatment
Participants will experience clinically significant improvements in fasting glucose with a signal for differential benefit compared to delayed intervention participants.	Finger-prick blood sample via a point-of-care Accu-Check glucometer will be used to obtain fasting glucose.	12 week and 24 weeks post-treatment
Participants in the intervention will manifest clinically significant change in physical activity outcomes targeted in the intervention.	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.	12 week and 24 weeks post-treatment
Participants in the intervention ward will manifest clinically significant improvements in dietary quality outcomes targeted in the intervention.	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	12 week and 24 weeks post-treatment

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Moghboeba Mosavel, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Cardiometabolic Disease
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: HM20024014 Phase 2; 1R01DK132373 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No