Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity

Sponsor

University of Southern Mississippi (Other)

Overall Status

Recruiting

CT.gov ID

NCT03855566

Collaborator

My Brother's Keeper (Other)

400

Enrollment

Location

Arm

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Intensive behavioral therapy for obesity	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity Among Young to Middle Aged African American Adults in Mississippi

Actual Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention Enrolled participants will receive the intervention.	Behavioral: Intensive behavioral therapy for obesity Approximately 24, 20 minute sessions over 12 months focused on diet and physical activity behavior change goals to promote weight loss. Framework includes health belief model, transtheoretical model and motivational interviewing.

Arm

Intervention/Treatment

Other: Intervention

Enrolled participants will receive the intervention.

Behavioral: Intensive behavioral therapy for obesity

Approximately 24, 20 minute sessions over 12 months focused on diet and physical activity behavior change goals to promote weight loss. Framework includes health belief model, transtheoretical model and motivational interviewing.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Southern Mississippi	Hattiesburg	Mississippi	United States	39406-0001

Sponsors and Collaborators

University of Southern Mississippi
My Brother's Keeper

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Southern Mississippi

ClinicalTrials.gov Identifier:

NCT03855566

Other Study ID Numbers:

P20GM103476

First Posted:

Feb 26, 2019

Last Update Posted:

Jun 15, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Jun 15, 2021