Childhood Obesity Treatment Designed for Low Income and Hispanic Families

NCT05041855 | Active Not Recruiting

• 2 other identifiers: 21-37211R01DK130176-01
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Childhood Obesity; Childhood obesity treatment; Adolescent obesity; Childhood Obesity Prevention; Family; Community; Physical activity; Nutrition; Hispanic; Latino; Motivational Interviewing; Food Insecurity

Outcome Measures

Primary Outcomes (2)

• Change in Body Mass Index (BMI) %95 in children with obesity (treatment)

  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).

  From Baseline to Month 18

• Change in Body Mass Index (BMI) %95 in healthy and overweight children (prevention)

  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.

  From Baseline to Month 18

Secondary Outcomes (34)

• Change in Body Mass Index (BMI) %95 in children with obesity (treatment)

  From Baseline to Month 12

• Change in Body Mass Index (BMI) %95 in healthy and overweight children (prevention)

  From Baseline to Month 12

• Change in nutrition aspects of the home environment as measured by the Comprehensive Home Environment Survey (CHES)

  Baseline, Month 18

• Change in physical activity and media aspects of the home environment as measured by the Comprehensive Home Environment Survey (CHES)

  Baseline, Month 18

• Change from Baseline in food insecurity at 18 months as measured by the US Department of Agriculture (USDA) Household Food Security Survey scores

  Baseline, Month 18

Study Arms (2)

Community based childhood obesity intervention

EXPERIMENTAL

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.

Behavioral: The Healthy Living Program/La Vida Saludable

Primary care based childhood obesity intervention

ACTIVE COMPARATOR

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

Behavioral: Recommended Treatment of Obesity in Primary Care

Interventions

The Healthy Living Program/La Vida Saludable BEHAVIORAL

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

Also known as: HeLP

Community based childhood obesity intervention

Recommended Treatment of Obesity in Primary Care BEHAVIORAL

A healthy lifestyle counseling protocol that enhances usual primary care

Also known as: RTOP

Primary care based childhood obesity intervention

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado State University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

Colorado State University-College of Health and Human Sciences

Fort Collins, Colorado, 80523, United States

Location

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  BACKGROUND

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• Haemer, M., et al. One-Year Outcomes from a Controlled Trial of Family-Inclusive Weight Management in Underserved Children. in Pediatric Academic Societies. 2015. San Diego, CA

  BACKGROUND

• Haemer, M., et al., Food Neophobia in Latino Preschoolers: Correlation with Intake and Pilot Intervention Results, in American Society of Nutrition Annual Meeting at Experimental Biology. 2014: San Diego, CA

  BACKGROUND

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• Haemer M, Tong S, Bracamontes P, Gritz M, Osborn B, Perez-Jolles M, Shomaker L, Steen E, Studts C, Boles R. Randomized-controlled trial of a whole-family obesity prevention and treatment intervention designed for low-income Hispanic families: HeLP the healthy living program. Contemp Clin Trials. 2023 Dec;135:107359. doi: 10.1016/j.cct.2023.107359. Epub 2023 Oct 16.

  PMID: 37852530 DERIVED

Related Links

• Evidence Synthesis, No. 150: Screening for Obesity and Interventions for Weight Management in Children and Adolescents: A Systematic Evidence Review for the U.S. Preventive Services Task Force : Agency for Healthcare Research and Quality (US)
• USDA. Food Security in the U.S. - Survey Tools.
• FITNESSGRAM by GreenLight Fitness
• Pew Research Center - Hispanic Trends. Demographic and Economic Profiles of Hispanics by State and County, 2014. 2020
• Share\_our\_Strength. Cooking Matters Hands-On Cooking Courses. \[web page\] 2019
• US\_Census\_Bureau. Detailed Languages Spoken at Home and Ability to Speak English for the Population 5 Years and Over: 2009-2013. 2015 Oct 28, 2015
• ServSafe. ServSafe - Food Safety Training. 2020 2020

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Matthew A Haemer, MD MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Family participants (children and their caregivers) will be randomized to the Healthy Living Program group intervention or the Recommended Treatment of Obesity in Primary Care individual intervention for an observation period of 18 months from baseline.

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: November 15, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)