Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity

NCT03855566 | Terminated DMC

• 1 other identifier: P20GM103476
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Weight Changes

  Weight loss at 0, 6 and 12 months

  0, 6 and 12 months

• Retention

  Number of enrolled participants who complete the program

  12 months

Study Arms (1)

Intervention

OTHER

Enrolled participants will receive the intervention.

Behavioral: Intensive behavioral therapy for obesity

Interventions

Intensive behavioral therapy for obesity BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Mississippi: lead
• My Brother's Keeper, Inc.: collaborator

Study Sites (1)

The University of Southern Mississippi

Hattiesburg, Mississippi, 39406-0001, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Adiposity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 26, 2019
• Study Start: June 1, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

US (1)