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Parent-Based Treatment for Pediatric Overweight (PO)

Mount Sinai Health System logo

Mount Sinai Health System

Status and phase

Completed
Phase 2
Phase 1

Conditions

Overweight
Obesity

Treatments

Behavioral: FBT-PO
Behavioral: NEC

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00807560
1R21HD057394-01 (U.S. NIH Grant/Contract)
GCO 07-0216

Details and patient eligibility

About

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.

Full 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.

Enrollment

77 patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

77 participants in 2 patient groups

FBT-PO
Experimental group
Description:
Family Based Therapy for Pediatric Overweight.
Treatment:
Behavioral: FBT-PO
NEC-control
Active Comparator group
Description:
Nutritional Educational Control Condition (NEC).
Treatment:
Behavioral: NEC

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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