Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Behavioral: Intensive behavioral therapy for obesity

• Registration Number: NCT03855566
• Lead Sponsor: University of Southern Mississippi

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

Not available

Study Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-26
• Study Start: 2019-06-01
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Body mass index >/=28
• 25 to 50 years of age
• history or risk of preventable co-morbidities (ie. diabetes, hypertension, and/or dyslipidemia)

Exclusion Criteria

• Body mass index <28
• <25 years of age
• >50 years of age
• no history or risk of preventable obesity comorbidities
• Any disease diagnosis (ie. cancer) where weight loss is contraindicated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Intensive behavioral therapy for obesity	Enrolled participants will receive the intervention.

Primary Outcome Measures

Name	Time	Method
Weight Changes	0, 6 and 12 months	Weight loss at 0, 6 and 12 months
Retention	12 months	Number of enrolled participants who complete the program

Trial Locations

Locations (1)

The University of Southern Mississippi; 🇺🇸 Hattiesburg, Mississippi, United States