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Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity

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ClinicalTrials.gov Identifier: NCT03855566
Recruitment Status : Not yet recruiting
First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Jackson State University
My Brother's Keeper, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Intensive behavioral therapy for obesity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : December 15, 2023

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Weight Changes [ Time Frame: 0, 6 and 12 months ]
    Weight loss at 0, 6 and 12 months

  2. Retention [ Time Frame: 12 months ]
    Number of enrolled participants who complete the program



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index >/=30
  • 18 to 50 years of age
  • history or risk of preventable co-morbidities (ie. diabetes, hypertension, and/or dyslipidemia)

Exclusion Criteria:

  • Body mass index <30
  • <18 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

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Responsible Party: University of Southern Mississippi
ClinicalTrials.gov Identifier: NCT03855566    
Other Study ID Numbers: P20GM103476 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms