Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03855566
• Other study ID #: P20GM103476
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2023
• Source: University of Southern Mississippi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

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.

Locations

Country	Name	City	State
United States	The University of Southern Mississippi	Hattiesburg	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Mississippi	My Brother's Keeper

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Changes	Weight loss at 0, 6 and 12 months	0, 6 and 12 months
Primary	Retention	Number of enrolled participants who complete the program	12 months