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NCT04027426 · ClinicalTrials.gov registry record · NA
Families Becoming Healthy Together
A NA study of Obesity and Childhood Obesity, sponsored by The University of Tennessee, Knoxville.
- Completed
- Registry status
- NA
- Development phase
- 83
- Enrollment target
- 1
- Study location
NCT04027426 is a NA study of Obesity and Childhood Obesity that has completed, run by The University of Tennessee, Knoxville. The registered enrollment target is 83 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04027426, a NA study of Obesity and Childhood Obesity, has completed, sponsored by The University of Tennessee, Knoxville.
- COMPLETED
- Registry status
- NA
- Development phase
- 83 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators plan to implement a novel limited RED (high-energy-dense) food variety prescription within a 18-month FBT to examine its effect on 18-month body mass index (BMI). This will be the first randomized control trial to examine how habituation rate, assessed via salivary habituation, mediates reduction in RED food intake, overall energy intake, and reductions in BMI over time, as well as if baseline habituation rate is a behavioral phenotype that moderates BMI outcomes. One hundred fifty-six children aged 8 to 12 years at \> 85th percentile BMI will be randomized to one of two, 18-month interventions compared in our 6-month pilot study: FBT (family-based behavioral obesity treatment) or FBT+Variety. Child and adult caregiver assessments will occur at 0, 6, 12, and 18 months on anthropometrics, dietary intake (RED food variety, energy, and diet quality), habituation, and physical activity.
Conditions Studied
Interventions
- BEHAVIORAL FBT
- BEHAVIORAL FBT+Variety
Study Locations (1)
Tennessee
- Healthy Eating and Activity Lab, University of Tennessee - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2019-10-29 |
| Est. Completion | 2025-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04027426
The ClinicalTrials.gov registry entry for NCT04027426 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (90% lower). The listed sponsor is The University of Tennessee, Knoxville, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which FBT is the first listed.
NCT04027426 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT04027426 about?
NCT04027426 is a clinical study titled "Families Becoming Healthy Together". The investigators plan to implement a novel limited RED (high-energy-dense) food variety prescription within a 18-month FBT to examine its effect on 18-month body mass index (BMI). This will be the first randomized control trial to examine how habituation rate, assessed via salivary habituation, med...
What is the current status of trial NCT04027426?
This trial is currently completed. It is a NA study. The enrollment target is 83 participants. The study started on 2019-10-29. Estimated completion is 2025-02-28.
What conditions does trial NCT04027426 study?
This clinical trial studies the following conditions: Obesity, Childhood Obesity.
What interventions are being tested in trial NCT04027426?
The interventions under investigation include: FBT (BEHAVIORAL), FBT+Variety (BEHAVIORAL).
Who is sponsoring clinical trial NCT04027426?
This trial is sponsored by The University of Tennessee, Knoxville, which has 81 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04027426 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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