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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05544708
• Other study ID #: HM20024014
• Secondary ID: 1R01DK132373
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: Morgan Meyer
• Phone: (804) 827-2250
• Email: morgan.meyer[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 1, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Wellness Engagement Intervention
Train for, recruit participants into, and lead a 12-week lifestyle intervention delivered via weekly group meetings

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: House Chat Leaders (HCL)	The number of house chat leaders successfully recruited, trained, and retained.	18 months
Primary	Feasibility: Participants	The average number of participants recruited by the HCLs.	18 months
Primary	Feasibility: Delivery Model	The number of intervention sessions delivered; the number of planned session topics that were covered	12 weeks
Secondary	Acceptability: Attendance	The average number of sessions attended by participants.	12 weeks
Secondary	Acceptability: Retention	The average number of HCL and participants who are retained in the program	12 weeks