A Pragmatic Family-Centered Approach to Childhood Obesity Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,460
- Locations
- 7
- Primary Endpoint
- Child percent overweight
Study Overview
Brief Summary
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
Note: our enrollment number includes two participants (one child and one parent) from each enrolled family.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Arms & Interventions
Enhanced Standard of Care (eSOC)
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.
Intervention: eSOC program (Behavioral)
Family-Based Behavioral Treatment (FBT + eSOC)
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.
Intervention: eSOC program (Behavioral)
Family-Based Behavioral Treatment (FBT + eSOC)
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.
Intervention: FBT program (Behavioral)
Outcomes
Primary Outcomes
Child percent overweight
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported