- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03855566
Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity
July 14, 2023 updated by: University of Southern Mississippi
Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity Among Young to Middle Aged African American Adults in Mississippi
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mississippi
-
Hattiesburg, Mississippi, United States, 39406-0001
- The University of Southern Mississippi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention
Enrolled participants will receive the intervention.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Changes
Time Frame: 0, 6 and 12 months
|
Weight loss at 0, 6 and 12 months
|
0, 6 and 12 months
|
|
Retention
Time Frame: 12 months
|
Number of enrolled participants who complete the program
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2019
Primary Completion (Actual)
May 31, 2023
Study Completion (Actual)
May 31, 2023
Study Registration Dates
First Submitted
February 21, 2019
First Submitted That Met QC Criteria
February 25, 2019
First Posted (Actual)
February 26, 2019
Study Record Updates
Last Update Posted (Actual)
July 18, 2023
Last Update Submitted That Met QC Criteria
July 14, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P20GM103476 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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