Childhood Obesity Treatment Designed for Low Income and Hispanic Families

RECRUITING

I'm interested ...!!

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:

🦠 Pediatric Obesity 🦠 Healthy Eating 🦠 Physical Activity 🦠 Minority Health 🦠 Mindfulness 🦠 Family 🦠 Counseling

🗓️ Study Start (Actual) 15 November 2021

🗓️ Primary Completion (Estimated) 31 May 2026

✅ Study Completion (Estimated) 31 May 2027

👥 Enrollment (Estimated) 658

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Aurora, Colorado, United States

📍 Fort Collins, Colorado, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* Child aged 2-16yrs
* With overweight or obesity (BMI \>85th percentile)
* Referred by PCP
* Primary Adult Caregiver
* Up to two siblings of any BMI status (if multiple siblings are available, enrollment goals stratified by age and BMI will be used to select siblings for enrollment.)

Exclusion Criteria:

* Parent without fluency in either Spanish or English
* Current participation in a clinically referred obesity treatment program
* Child non-ambulatory, non-verbal, or diagnosed with a genetic syndrome associated with obesity.
* Children with severe depression on initial screening (CES-D \>/=40 or suicidal ideation) will be excluded and referred to psychiatric treatment and therapy.
* Children who have been diagnosed by PCP at time of initial screening with severe comorbidities of obesity, including:
* Type 2 diabetes
* Stage 2 hypertension
* Severe hyperlipidemia
* Severe obstructive sleep apnea will be excluded from the study and directed to the only Tertiary Care Childhood Obesity Treatment program in the state of Colorado: Lifestyle Medicine at Children's Hospital Colorado.

Ages Eligible for Study: 2 Years to N/A (CHILD, ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 3 September 2021
First Submitted that Met QC Criteria 3 September 2021
First Posted 13 September 2021

Study Record Updates

Last Update Submitted that Met QC Criteria 9 June 2023
Last Update Posted 13 June 2023
Last Verified June 2023