Childhood Obesity Treatment Designed for Low Income and Hispanic Families

University of Colorado Denver (CU Denver)

Status: Active, not recruiting

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

Treatments: Behavioral: Recommended Treatment of Obesity in Primary Care; Behavioral: The Healthy Living Program/La Vida Saludable

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05041855

21-3721

1R01DK130176-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Full description

This study is a Randomized Controlled Trial (RCT) to learn about how well a family childhood weight management program works compared to healthy lifestyle counseling by providers at participating clinics. The goal is to compare weight change in children with obesity from low-income predominantly Hispanic/Latino families that will participate in the program, the Healthy Living Program (HeLP) vs. Recommended Treatment of Obesity in Primary Care (RTOP). Low-income children with obesity from mostly Hispanic clinical populations will be referred to the project by their primary doctors and will be enrolled into either HeLP or RTOP. Families (including siblings and caregivers) who are in HeLP will be offered 12 sessions at local rec centers where health educators and fitness trainers will teach them about parenting skills, nutrition, fitness, and mindfulness. Families who are in RTOP will receive an enhanced version of the care that is usually provided at their primary care clinics. Providers will be trained in a skill called Motivational Interviewing and use an electronic tool called "HeartSmartKids" to help families make healthy lifestyle changes. Families who are in RTOP will go to follow-up visits every 3 months and will go to HeLP after 18 months.

Aim 1 (Treatment): To compare the BMI change relative to the 95th percentile for age and sex in children with obesity in 3 different age groups (2-6, 7-12, and 13-16 years old) 18 months after being in either HeLP or RTOP.

Aim 2 (Prevention): To compare the weight change in healthy and unhealthy weight 2-6-year-old children who have siblings with obesity and are in either HeLP or RTOP.

Aim 3 (Implementation): To describe implementation processes of HeLP and RTOP using a framework called RE-AIM: R-Reach: Is the project reaching the people it needs to reach? E-Effectiveness: Is the program effective? A-Adoption: are the health educators, providers, and clinics promoting and doing the program? I-Implementation: Are the health educators, providers and clinics delivering the intervention as intended? M-Maintenance: Is the intervention working to help children with their weight and healthy lifestyle changes? The cost of delivering the program will also be studied to inform potential sustainability.

Enrollment: 554 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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554 participants in 2 patient groups

Community based childhood obesity intervention

Experimental group

Description:

A novel family-inclusive childhood obesity treatment program consisting of 12 family group sessions delivered in English and Spanish by health educators at community recreation centers, followed by three group booster sessions occurring every 6 months.

Treatment:

Behavioral: The Healthy Living Program/La Vida Saludable

Primary care based childhood obesity intervention

Active Comparator group

Description:

A healthy lifestyle counseling intervention delivered by trained primary care providers and health educators at visits occurring every 3 months.

Treatment:

Behavioral: Recommended Treatment of Obesity in Primary Care