Parent-Based Treatment for Pediatric Overweight (PO)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: FBT-PO; Behavioral: NEC

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University Of Chicago
  • New York
    • NY, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FBT-PO; Family Based Therapy for Pediatric Overweight.	Behavioral: FBT-PO; The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases.; Other Names: Family Based Therapy for Pediatric Overweight
Active Comparator: NEC-control; Nutritional Educational Control Condition (NEC).	Behavioral: NEC; Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.; Other Names: Nutritional Educational Control Condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI Z Score	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).	baseline
BMI Z Score	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)	up to 44 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Katherine L Loeb, PH.D., Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 11, 2008
• First Submitted That Met QC Criteria: December 11, 2008
• First Posted (Estimate): December 12, 2008

Study Record Updates

• Last Update Posted (Estimate): January 8, 2016
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Adolescents; Obesity; Overweight; Family Therapy
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: GCO 07-0216; 1R21HD057394-01 (U.S. NIH Grant/Contract)