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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05544708
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
10
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14
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Wellness Engagement Intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Cluster randomized designCluster randomized design
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

House Chat Leaders will undergo training to recruit and deliver a lifestyle intervention to members of their social networks. HCL in the intervention group will deliver the intervention immediately following baseline visits and randomization.

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

No Intervention: Delayed Intervention

House Chat Leaders will undergo training to recruit and deliver a lifestyle intervention to members of their social networks. HCL in the delayed intervention group will deliver the intervention after 24 week data collection visits are complete.

Outcome Measures

Primary Outcome Measures

  1. Feasibility: House Chat Leaders (HCL) [18 months]

    The number of house chat leaders successfully recruited, trained, and retained.

  2. Feasibility: Participants [18 months]

    The average number of participants recruited by the HCLs.

  3. Feasibility: Delivery Model [12 weeks]

    The number of intervention sessions delivered; the number of planned session topics that were covered

Secondary Outcome Measures

  1. Acceptability: Attendance [12 weeks]

    The average number of sessions attended by participants.

  2. Acceptability: Retention [12 weeks]

    The average number of HCL and participants who are retained in the program

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Moghboeba Mosavel, PhD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT05544708
Other Study ID Numbers:
  • HM20024014
  • 1R01DK132373
First Posted:
Sep 16, 2022
Last Update Posted:
Sep 16, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Virginia Commonwealth University

Study Results

No Results Posted as of Sep 16, 2022