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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-12

Study Completion Date

2024-07-26

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.

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Detailed Description

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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

eSOC program

Intervention Type BEHAVIORAL

American Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling

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.

Group Type ACTIVE_COMPARATOR

eSOC program

Intervention Type BEHAVIORAL

American Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling

FBT program

Intervention Type BEHAVIORAL

An intensive,comprehensive, behavioral intervention aligned with the US Preventive Services Task Force recommendations for childhood obesity screening and counseling.

Interventions

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eSOC program

American Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling

Intervention Type BEHAVIORAL

FBT program

An intensive,comprehensive, behavioral intervention aligned with the US Preventive Services Task Force recommendations for childhood obesity screening and counseling.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

• 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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes