Parent-Based Treatment for Pediatric Overweight

Phase 1

Completed

Brief Summary: The purpose of this study is to determine whether a parent/guardian intervention for adolescent overweight/obesity more effective than a nutritional counseling education curriculum for reducing body mass index z-score (BMI Z-score) and related outcomes.

Detailed Description: Rates of pediatric overweight (PO) among Americans are increasing and associated with significant psychological, social, quality of life, and health related outcomes. Because of the broad mental and physical health implications of PO and the difficulty in sustaining weight loss as an adult, it is of interest to find successful methods of weight loss and/or prevention of weight gain for obese children and adolescents. The family unit is a logical and empirically supported point of intervention for PO. Interventions on this level have shown good long term efficacy in young children, but there is very little research on adolescent family intervention. Within the eating disorder literature, there is growing support for the efficacy of family-based interventions (FBI) for adolescents. Given its trans-developmental applicability, focus on family as the unit of intervention, and utility in creating a healthy eating environment, FBI is a logical candidate for adaptation to intervention for PO and intervention for at-risk for overweight youth (FBI-PO). The core of the current project is to test the feasibility and efficacy of an adapted FBI manual for adolescent overweight and at-risk for overweight in an outpatient eating and weight disorders clinic and compare this modality to a minimal nutritional educational control (NEC) condition.

Recruitment & Eligibility

Inclusion Criteria

Ages 13-17
Male and female
Living with at least one parent or guardian who is willing to participate in treatment
A BMI percentile >85% for gender and age (e.g., overweight or at risk for overweight)

Exclusion Criteria

Current psychotic illness
Current alcohol/drug dependence
Active suicidality
Eating disorders (e.g., binge eating disorder)
History of bariatric surgery
Medication associated with significant weight changes (e.g., antipsychotics)
Serious medical or physical conditions resulting in significant weight changes (e.g., pregnancy, genetic disorders).
Complications of obesity that contraindicate moderate physical activity (e.g. orthopedic disorders)

Arm && Interventions

Group	Intervention	Description
FBT-PO	FBT-PO	Family Based Therapy for Pediatric Overweight.
NEC-control	NEC	Nutritional Educational Control Condition (NEC).

Primary Outcome Measures

Name	Time	Method
BMI Z Score	up to 44 weeks	Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html)

Secondary Outcome Measures

Name	Time	Method
Waist Measurement	up to 44 weeks	Waist measurement in inches. This is not a primary outcome variable.
Weight	up to 44 weeks	This variable informs the calculation of the outcome variable of BMI z score.
BMI	up to 44 weeks	Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.
Percent Completion	at 44 weeks	Percent of participants who completed the trial to assess feasibility and retention in the trial
Hip Measurement	up to 44 weeks	Hip measurement in inches. This is not a primary outcome variable.
Height	up to 44 weeks	This variable informs the calculation of the outcome variable of BMI Z score.
BMI Percentile	up to 44 weeks	Body Mass Index percentile. This is not a primary outcome variable.

Locations (2): The University of Chicago
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Chicago, Illinois, United States
Icahn School of Medicine at Mount Sinai
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NY, New York, United States