Clinical trial NCT06172582: WE Project: 2.0 Grassroots Wellness Coaching (Phase 2)
Official title: WE Project: 2.0 Grassroots Wellness Coaching. Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management (Phase 2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Cardiometabolic Disease
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-12-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This behavioral weight loss intervention will span 12 weeks. Participants will be randomized to one of two groups within ward (intervention and delayed intervention control) wherein all participants will receive the same 12-week program.
Primary purpose: OTHER

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.

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. 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.

Eligibility criteria: 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
* 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

Primary outcomes:
measure: Participants in the intervention ward will manifest clinically significant change in physical activity outcomes targeted in the intervention.
timeFrame: 12 week and 24 weeks post-treatment
measure: Participants in the intervention ward will manifest clinically significant Change in diet behavioral outcomes targeted in the intervention.
timeFrame: 12 week and 24 weeks post-treatment
measure: Intervention ward participants will manifest clinically significant change in adiposity
timeFrame: 12 week and 24 weeks post-treatment
measure: Subjects will manifest clinically significant change in Secondary markers of cardiometabolic risk through changed blood pressure readings
timeFrame: 12 week and 24 weeks post-treatment
measure: Subjects will manifest clinically significant change in secondary markers of cardiometabolic risk with changed Fasting Glucose Values
timeFrame: 12 week and 24 weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Moghboeba Mosavel
role: PRINCIPAL_INVESTIGATOR
References: