Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers (TEAM UP)

The Washington University

Status: Completed

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

Treatments: Behavioral: FBT program; Behavioral: eSOC program

Study type: Interventional

Funder types: Other

Identifiers

NCT03843424

PCS-2017C2-7542 (Other Grant/Funding Number)

201810158

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,460 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,460 participants in 2 patient groups

Enhanced Standard of Care (eSOC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: eSOC program

Family-Based Behavioral Treatment (FBT + eSOC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: FBT program

Behavioral: eSOC program