Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity

NCT ID: NCT03855566

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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Group Type OTHER

Intensive behavioral therapy for obesity

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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My Brother's Keeper

UNKNOWN

Sponsor Role collaborator

University of Southern Mississippi

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The University of Southern Mississippi

Hattiesburg, Mississippi, United States

Site Status

Countries

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United States

Other Identifiers

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P20GM103476

Identifier Type: NIH

Identifier Source: org_study_id

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