Parent-Based Treatment for Pediatric Overweight (PO)

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT00807560
First received: December 11, 2008
Last updated: December 2, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Overweight
Obesity
Behavioral: FBT-PO
Behavioral: NEC
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Parent-Based Treatment for Pediatric Overweight

Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • BMI Z Score [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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).

  • BMI Z Score [ Time Frame: up to 44 weeks ] [ Designated as safety issue: No ]
    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:
  • Percent Completion [ Time Frame: at 44 weeks ] [ Designated as safety issue: No ]
    Percent of participants who completed the trial to assess feasibility and retention in the trial

  • Waist Measurement [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Waist measurement in inches. This is not a primary outcome variable.

  • Waist Measurement [ Time Frame: up to 44 weeks ] [ Designated as safety issue: No ]
    Waist measurement in inches. This is not a primary outcome variable.

  • Hip Measurement [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Hip measurement in inches. This is not a primary outcome variable.

  • Hip Measurement [ Time Frame: up to 44 weeks ] [ Designated as safety issue: No ]
    Hip measurement in inches. This is not a primary outcome variable.

  • Height [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This variable informs the calculation of the outcome variable of BMI Z score.

  • Height [ Time Frame: up to 44 weeks ] [ Designated as safety issue: No ]
    This variable informs the calculation of the outcome variable of BMI Z score.

  • Weight [ Time Frame: baseline ] [ Designated as safety issue: No ]
    This variable informs the calculation for the outcome variable of BMI Z score.

  • Weight [ Time Frame: up to 44 weeks ] [ Designated as safety issue: No ]
    This variable informs the calculation of the outcome variable of BMI z score.

  • BMI [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score.

  • BMI [ Time Frame: up to 44 weeks ] [ Designated as safety issue: No ]
    Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.

  • BMI Percentile [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Body Mass Index percentile. This is not a primary outcome variable.

  • BMI Percentile [ Time Frame: up to 44 weeks ] [ Designated as safety issue: No ]
    Body Mass Index percentile. This is not a primary outcome variable.


Enrollment: 77
Study Start Date: September 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Nutritional Educational Control Condition

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.
  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807560

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, New York
Icahn School of Medicine at Mount Sinai
NY, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
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
  More Information

Additional Information:
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00807560     History of Changes
Other Study ID Numbers: GCO 07-0216  1R21HD057394-01 
Study First Received: December 11, 2008
Results First Received: March 4, 2014
Last Updated: December 2, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Icahn School of Medicine at Mount Sinai:
Overweight
Obesity
Adolescents
Family Therapy

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 26, 2016