CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 554 enrolled
Drug / intervention
The Healthy Living Program/La Vida Saludable +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05041855
NCT05041855N/AActive

Family Inclusive Childhood Obesity Treatment Designed for Low Income and Hispanic Families

University of Colorado, Denver·interventional·Posted Sep 13, 2021·Updated Mar 30, 2025

In Brief

A clinical study evaluating The Healthy Living Program/La Vida Saludable and Recommended Treatment of Obesity in Primary Care for Pediatric Obesity and 6 related conditions. Active but no longer recruiting, targeting 554 participants across 2 sites.

Detailed 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.

Study Details

Timeline

N/AActiveOverdue
20222023202420252026
First PostedSep 13, 2021
Enrollment StartNov 15, 2021
Primary CompletionMay 31, 2026
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 4.8 years ago

Interventions

The Healthy Living Program/La Vida Saludablebehavioral

A whole-family group childhood obesity intervention delivered at community recreation centers

Recommended Treatment of Obesity in Primary Carebehavioral

A healthy lifestyle counseling protocol that enhances usual primary care