NCT05544708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

2.1 years

First QC Date

September 13, 2022

Last Update Submit

October 20, 2025

Conditions

Obesity

Keywords

cardiometabolic disease

Outcome Measures

Primary Outcomes (3)

  • Feasibility: House Chat Leaders (HCL)

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

    18 months

  • Feasibility: Participants

    The average number of participants recruited by the HCLs.

    18 months

  • Feasibility: Delivery Model

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

    12 weeks

Secondary Outcomes (2)

  • Acceptability: Attendance

    12 weeks

  • Acceptability: Retention

    12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Wellness Ambassadors 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

Delayed Intervention

NO INTERVENTION

Wellness Ambassadors 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.

Interventions

Wellness Engagement InterventionBEHAVIORAL

Train for, recruit participants into, and lead a 12-week lifestyle intervention delivered via weekly group meetings

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Moghboeba Mosavel, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cluster randomized design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

May 1, 2023

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)