Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Childhood Obesity Treatment Designed for Low Income and Hispanic Families
NCT05041855 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05041855
The ClinicalTrials.gov registry entry for NCT05041855 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 554 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,447 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05041855 reports 2 study locations spanning 1 distinct geographic area — top geographies include Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05041855?
This trial is sponsored by University of Colorado, Denver, which has 1,447 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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