Back to resultsTelenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity
Primary Purpose
Obesity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive behavioral therapy for obesity
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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
Sites / Locations
- The University of Southern Mississippi
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
Enrolled participants will receive the intervention.
Outcomes
Primary Outcome Measures
Weight Changes
Weight loss at 0, 6 and 12 months
Retention
Number of enrolled participants who complete the program
Secondary Outcome Measures
Full Information
NCT ID
NCT03855566
First Posted
February 21, 2019
Last Updated
July 14, 2023
Sponsor
University of Southern Mississippi
Collaborators
My Brother's Keeper
1. Study Identification
Unique Protocol Identification Number
NCT03855566
Brief Title
Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity
Official Title
Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity Among Young to Middle Aged African American Adults in Mississippi
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was disrupted by and results confounded by the COVID-19 pandemic and there it was not possible to meet study goals within the required timeframe.
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Mississippi
Collaborators
My Brother's Keeper
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
Enrolled participants will receive the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Intensive behavioral therapy for obesity
Intervention Description
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 Measure Information:
Title
Weight Changes
Description
Weight loss at 0, 6 and 12 months
Time Frame
0, 6 and 12 months
Title
Retention
Description
Number of enrolled participants who complete the program
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The University of Southern Mississippi
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39406-0001
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity
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