Viewing Study NCT06546696



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06546696
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-06

Brief Title: The ADAPT Trial Adapting Evidence-Based Obesity Interventions in Community Settings
Sponsor: None
Organization: None

Study Overview

Official Title: The ADAPT Trial Adapting Evidence-Based Obesity Interventions in Community Settings
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Evidence-based obesity treatment is inaccessible to most children in the United States This lack of access is a source of health inequity whereby children from rural and minority communities who have the highest rates of childhood obesity are also the least likely to receive an evidence-based intervention Developing strategies to improve access to evidence-based obesity interventions could reduce health disparities by improving reach to these underserved communities The premise of this study is that using a systematic framework to adapt a community-based behavioral intervention for childhood obesity that accounts for individual family and community factors will increase reach and effectiveness among low-income minority and rural populations COACH is a multi-level obesity intervention that supports 1 the individual child through developmentally appropriate health behavior curriculum 2 the family by directly addressing parent weight loss and engaging parents as agents of change for their children and 3 the community by building the capacity of local community centers to offer parent-child programming The investigators propose testing the process of adapting COACH in a cluster-randomized trial
Detailed Description: In Aim 1 the investigators will conduct a community readiness assessment for COACH in 50 community centers serving rural minority and low-income families in middle TN In 25 randomly selected community centers the investigators will use a systematic process to adapt the intervention protocol based on the assessment results while maintaining fidelity to COACHs core components In Aim 2 in a cluster-randomized trial the investigators will test the comparative effectiveness of each implementation strategy adaptation vs original program on the implementation outcomes of reach adoption implementation and maintenance In Aim 3 the investigators will test the comparative effectiveness of the adapted and original intervention

This research is innovative because it uses adaptation science as a potential solution to reduce health disparities in childhood obesity By testing this intervention in a community resource available to 230 million Americans community centers the investigators aim to create a scalable obesity intervention that could be implemented in traditionally underserved populations across the country This study will also develop and test a theory-based process for adapting behavioral interventions for both obesity and other health outcomes among diverse rural and urban communities

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None