Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06172582
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-11-09
Brief Title:
WE Project 20 Grassroots Wellness Coaching Phase 2
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
WE Project 20 Grassroots Wellness Coaching Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management Phase 2
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N80 18 years of age to participate in a 12-week lifestyle intervention delivered via weekly group meetings in the HCLs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK132373 | NIH | None | httpsreporternihgovquickSearch1R01DK132373 |