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NCT05041855 · ClinicalTrials.gov registry record · NA
Childhood Obesity Treatment Designed for Low Income and Hispanic Families
A NA study of Physical Activity and Pediatric Obesity, sponsored by University of Colorado, Denver.
- Active
- Registry status
- NA
- Development phase
- 554
- Enrollment target
- 2
- Study locations
NCT05041855: Active NA study of Physical Activity and Pediatric Obesity, sponsored by University of Colorado, Denver.
NCT05041855 is a NA study of Physical Activity and Pediatric Obesity that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 554 participants, above the 354-participant average among 131 other Physical Activity trials with a reported enrollment target (56% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05041855, a NA study of Physical Activity and Pediatric Obesity, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 554 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is a type-1 hybrid effectiveness-implementation RCT comparing a novel family-inclusive childhood obesity treatment program, the "Healthy Living Program" (HeLP), to a protocol that enhances usual primary care to deliver Recommended Treatment of Obesity in Primary Care (RTOP). Children with obesity and their families will be referred to the study by primary care providers and randomized to HeLP or RTOP. The clinical setting is a practice-based research network serving majority Hispanic and Medicaid-insured populations. The intensive phase and booster sessions of HeLP will take place at recreation centers located near the clinics and will be led by health educators employed by the clinics. Visits with primary care providers (PCPs) for HeLP maintenance or RTOP will occur at the clinics.
Primary Outcome
Change in BMI%95 as measured in 2-16 yr old children with obesity BMI%95 is the percentage a child's BMI represents of the BMI value at the 95th percentile for age and sex calculated using the Centers for Disease Control (CDC) program for Statistical Analysis System (SAS).
Conditions Studied
Interventions
- BEHAVIORAL The Healthy Living Program/La Vida Saludable
- BEHAVIORAL Recommended Treatment of Obesity in Primary Care
Study Locations (2)
Colorado
- University of Colorado Anschutz - Aurora
- Colorado State University-College of Health and Human Sciences - Fort Collins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 554 participants |
| Start Date | 2021-11-15 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
What the registry record for NCT05041855 still lists
NCT05041855 is an interventional study that assigns participants to a tested intervention. The registered 554 participants enrollment target is mid-sized for trials with a published cap, above the 354-participant average among 131 other Physical Activity trials with a reported enrollment target (56% higher).
The record links to 7 conditions, with Physical Activity appearing as the primary indexed condition, and to 2 interventions - of which The Healthy Living Program/La Vida Saludable is the first listed.
NCT05041855 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05041855 about?
NCT05041855 is a clinical study titled "Childhood Obesity Treatment Designed for Low Income and Hispanic Families". This study is a type-1 hybrid effectiveness-implementation RCT comparing a novel family-inclusive childhood obesity treatment program, the "Healthy Living Program" (HeLP), to a protocol that enhances usual primary care to deliver Recommended Treatment of Obesity in Primary Care (RTOP). Children with...
What is the current status of trial NCT05041855?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 554 participants. The study started on 2021-11-15. Estimated completion is 2026-05-31.
What conditions does trial NCT05041855 study?
This clinical trial studies the following conditions: Physical Activity, Pediatric Obesity, Mindfulness, Family, Counseling.
What interventions are being tested in trial NCT05041855?
The interventions under investigation include: The Healthy Living Program/La Vida Saludable (BEHAVIORAL), Recommended Treatment of Obesity in Primary Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT05041855?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05041855 being conducted?
This trial has 2 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05041855's enrollment target sits among peer trials
554 17th of 131 higher than 115 of 131 other Physical Activity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Physical Activity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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