TrialGlobe

Clinical trial

Childhood Obesity Treatment Designed for Low Income and Hispanic Families

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05041855

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age2 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionPediatric Obesity, Healthy Eating, Physical Activity, Minority Health, Mindfulness, Family, Counseling

Full registry criteria

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.

Treatments and study arms

The Healthy Living Program/La Vida Saludable

Behavioral

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

Recommended Treatment of Obesity in Primary Care

Behavioral

A healthy lifestyle counseling protocol that enhances usual primary care

Primary outcomes

Change in Body Mass Index (BMI) %95 in children with obesity (treatment)From Baseline to Month 18

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).

Change in Body Mass Index (BMI) %95 in healthy and overweight children (prevention)From Baseline to Month 18

Change in BMI%95 as measured in healthy and overweight 2-11 yr old siblings of the 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 CDC program for SAS.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

University of Colorado Anschutz🇺🇸 Aurora, Colorado, United States
Open map
Colorado State University-College of Health and Human Sciences🇺🇸 Fort Collins, Colorado, United States
Open map