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Clinical Trials/NCT00807560
NCT00807560
Completed
Phase 1

Parent-Based Treatment for Pediatric Overweight

Icahn School of Medicine at Mount Sinai2 sites in 1 country77 target enrollmentSeptember 2008

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Overweight
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
77
Locations
2
Primary Endpoint
BMI Z Score
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
June 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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)

Outcomes

Primary Outcomes

BMI Z Score

Time Frame: 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 Outcomes

  • Waist Measurement(up to 44 weeks)
  • Weight(up to 44 weeks)
  • BMI(up to 44 weeks)
  • Percent Completion(at 44 weeks)
  • Hip Measurement(up to 44 weeks)
  • Height(up to 44 weeks)
  • BMI Percentile(up to 44 weeks)

Study Sites (2)

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