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TerminatedNCT03855566Updated Jul 18, 2023

Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity

An interventional study of Intensive behavioral therapy for obesity in Obesity, sponsored by University of Southern Mississippi. Terminated at 1 site in United States. Open to participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-18.

Sponsored by University of Southern Mississippi · Not applicable, Interventional, and Treatment

Why this study was terminated
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.
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
25 Years to 50 Years
Sex
All
01

Study 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.

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Conditions studied

  • Obesity

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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 38 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Southern Mississippi is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Other
    Intervention

    Enrolled participants will receive the intervention.

    Behavioral: Intensive behavioral therapy for obesity

Interventions

  • BehavioralIntensive 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.

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What researchers measure

Primary outcomes

  1. Weight Changes

    Weight loss at 0, 6 and 12 months

    Time frame: 0, 6 and 12 months

  2. Retention

    Number of enrolled participants who complete the program

    Time frame: 12 months

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Study locations

1 site
  • The University of Southern Mississippi
    Hattiesburg, Mississippi 39406-0001, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03855566
Lead sponsor
University of Southern Mississippi
Collaborators
My Brother's Keeper
Responsible party
Sponsor
First posted
Feb 26, 2019
Start date
Jun 1, 2019
Primary completion
May 31, 2023
Completion
May 31, 2023
Last update
Jul 18, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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