Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers

Study Overview
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Brief Summary
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The US Preventive Services Task Force (USPSTF) recommends that providers screen children aged 6 years and older for obesity and offer or refer them to a comprehensive behavioral intervention (≥26 hours over a period of up to 12 months) to promote improvement in weight status. Family-based behavioral treatment (FBT) is an effective treatment that targets both child and parents and meets the USPSTF recommendations. By contrast, the American Medical Association (AMA) recommends a staged approach to childhood obesity screening and counseling, which begins with prevention counseling by the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. Our study compares a staged approach enhanced standard of care (eSOC) vs. eSOC + FBT, to provide families and PCPs with information on the best intervention approach for the behavioral treatment of childhood obesity. Our project seeks to fill the gap in the evidence on family-based weight management in primary care settings among diverse and underserved populations with a special focus on Black children, families insured by Medicaid, and sex differences.

Detailed Description
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Note: our enrollment number includes two participants (one child and one parent) from each enrolled family.

Official Title
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A Pragmatic Family-Centered Approach to Childhood Obesity Treatment

Conditions
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Obesity, Childhood, Pediatric Obesity, Childhood Obesity, Adolescent Obesity, Overweight, Overweight and Obesity, Overweight or Obesity, Overweight Adolescents, Weight Gain, Overnutrition, Body Weight, Body Weight Changes, Nutrition Disorders

Intervention / Treatment
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* Behavioral: eSOC program
* Behavioral: FBT program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for children include: have a BMI percentile ≥95th for age and sex; comfortable speaking English language; able to provide written or verbal (based on age) informed assent; willing to change diet, physical activity, and/or weight; patient of a participating clinic/practice; and able to participate in scheduled sessions. Inclusion Criteria for parents include: • comfortable speaking and reading English language. Exclusion Criteria include: families who plan to no longer have the child be a patient of any participating clinic/practice during any point in the 18-month study period; children with chronic conditions or on medications that substantially impact or interfere with growth, appetite, weight, or physical activity participation; families for whom the Primary Care Provider (PCP) or site PI thinks the intervention is clinically/medically inappropriate (e.g., developmental delay, or emotional or cognitive difficulties, if the PI/PCP believes these factors will interfere with study/intervention participation); and families in whom the parent or child exhibits eating disorder symptomatology.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enhanced Standard of Care (eSOC)<br>This group will receive the eSOC program. A minimum of 6 visits to the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. | Behavioral: eSOC program<br>* American Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling<br>|
| Active Comparator: Family-Based Behavioral Treatment (FBT + eSOC)<br>This group will receive eSOC plus the FBT program. Family-based behavioral treatment (FBT), an effective treatment that targets both child and parents meeting regularly with a health coach for healthy eating, activity, positive parenting strategies, and managing environmental cues. | Behavioral: eSOC program<br>* American Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling<br>Behavioral: FBT program<br>* An intensive,comprehensive, behavioral intervention aligned with the US Preventive Services Task Force recommendations for childhood obesity screening and counseling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child percent overweight |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Management, Child, Intervention, Weight Loss, Behavior Therapy, Nutrition