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NCT03431831 · ClinicalTrials.gov registry record · Phase 4
Assessment of and Treatment Applied to Food Addiction in a Rural Healthy Behaviors Clinic
A Phase 4 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 4
- Development phase
- 86
- Enrollment target
NCT03431831 is a Phase 4 study that has completed, run by University of Nebraska. The registered enrollment target is 86 participants.
The verdict
NCT03431831, a Phase 4 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 86 participants
- Enrollment target
Study Summary
Research purpose: The purpose of this pilot study is to assess obese clients for two phenotypes, those testing positive and those testing negative for Food Addiction (FA) (Yale Food Addiction Scale, YFAS) and determining the efficacy of four treatments: usual care (IC, dietary and physical activity instruction), individual motivational interviewing alone (MI), individual MI with pharmacotherapy (MI+P) for improving outcome measures within each phenotype, and pharmacological therapy (P). Background/significance: Obesity has long been an epidemic in the U.S. and other countries. Numerous approaches have been tried to address obesity with limited success. The YFAS is a relatively new, validated instrument that can help researchers and practitioners assess obese clients for food addiction. Meeting the YFAS diagnosis criteria for FA suggests the need for a stronger intervention with close monitoring to assist these clients in self-management of their eating and physical activity behaviors. Proposed methods/approach: The investigators propose assessing obese clients with the YFAS as part of their intake once they are referred to the Healthy Behaviors Clinic by Regional West physicians/practitioners. A nurse researcher with expertise in MI and a nurse practitioner will perform intake assessments, obtain consent and randomly assign participants in each phenotype (positive or negative for FA) to one of three treatment groups (usual care, individual MI alone, and individual MI with pharmacotherapy). Interventions will occur over 6 months. A clinical psychologist with expertise in the YFAS (University of Michigan) will serve as a consultant on this project and a registered dietitian (University of NebraskaLincoln) will serve as a co-investigator. Expected outcomes: The investigators expect that MI and MI+P and P will be more effective in improving outcome measures than IC. We also expect that response to the treatments will differ between the two obesity phenotypes (those t
Interventions
- BEHAVIORAL Intervention Control
- BEHAVIORAL Counselling
- DRUG Contrave
- DRUG Contrave and Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2022-07-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03431831
The ClinicalTrials.gov registry entry for NCT03431831 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Intervention Control is the first listed.
NCT03431831 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03431831 about?
NCT03431831 is a clinical study titled "Assessment of and Treatment Applied to Food Addiction in a Rural Healthy Behaviors Clinic". Research purpose: The purpose of this pilot study is to assess obese clients for two phenotypes, those testing positive and those testing negative for Food Addiction (FA) (Yale Food Addiction Scale, YFAS) and determining the efficacy of four treatments: usual care (IC, dietary and physical activity ...
What is the current status of trial NCT03431831?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 86 participants. The study started on 2017-07-01. Estimated completion is 2022-07-01.
What interventions are being tested in trial NCT03431831?
The interventions under investigation include: Intervention Control (BEHAVIORAL), Counselling (BEHAVIORAL), Contrave (DRUG), Contrave and Counseling (DRUG).
Who is sponsoring clinical trial NCT03431831?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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