Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-01 @ 7:16 AM
Study NCT ID:
NCT03855566
Status:
TERMINATED
Last Update Posted:
2023-07-18
First Post:
2019-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity
Sponsor:
University of Southern Mississippi
Organization:
Study Overview
Official Title:
Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity Among Young to Middle Aged African American Adults in Mississippi
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was disrupted by and results confounded by the COVID-19 pandemic and there it was not possible to meet study goals within the required timeframe.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Telenutrition Center will use the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) Framework to assess the implementation of an evidence-based, intensive behavior therapy (IBT) for obesity intervention (with a motivational interviewing \[MI\] framework) based on the Centers for Medicaid and Medicare Services (CMS) IBT for obesity benefit. The intervention will be examined under real-world conditions with technology supplementation to address obesity and related chronic disease among young adult (18-50 years of age) African Americans across the state. The intervention contact will model the CMS IBT for obesity benefit according to the patient contact schedule (of weekly visits in the first month, biweekly in months 2-7, and once a month per months 8-12) and include nutrition, stage of change and other physical and psychosocial assessments. Program delivery will be assisted by the "Bridge2U" web and mobile platform and supported in both clinic and community settings. The proposed project will shed new light on how IBT for obesity (and similar) models may be amended to facilitate the provision of health care resources in areas with limited to no resources, such as the state of Mississippi.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: