Childhood Obesity Treatment Designed for Low Income and Hispanic Families

Running, not enrolling · Not applicable

Conditions studied: Pediatric Obesity, Healthy Eating, Physical Activity, Minority Health, Mindfulness, Family, Counseling

In brief

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.

Key facts

Study ID

NCT05041855

Run by

University of Colorado, Denver

People needed

554

Starts

2021-11-15

Expected to finish

2026-05-31

Last updated by the study team

2025-03-30

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• University of Colorado Anschutz — Aurora, Colorado, United States
• Colorado State University-College of Health and Human Sciences — Fort Collins, Colorado, United States

Full record on ClinicalTrials.gov

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