Parent-Based Treatment for Pediatric Overweight (PO)

This study is currently recruiting participants.
Verified March 2012 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00807560
First received: December 11, 2008
Last updated: March 13, 2012
Last verified: March 2012

December 11, 2008
March 13, 2012
September 2008
September 2012   (final data collection date for primary outcome measure)
  • Height and weight (converted into BMI Z-score) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Height and weight (converted into BMI Z-score) [ Time Frame: Post 6-months ] [ Designated as safety issue: No ]
  • Height and weight (converted into BMI Z-score) [ Time Frame: Post 12-months ] [ Designated as safety issue: No ]
Height and weight(converted into BMI Z-score) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00807560 on ClinicalTrials.gov Archive Site
  • Youth and Parent/Guardian Eating Questionnaire Y-EDE Q [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Youth and Parent/Guardian Eating Questionnaire Y-EDE Q [ Time Frame: Post 6-months ] [ Designated as safety issue: No ]
  • Youth and Parent/Guardian Eating Questionnaire Y-EDE Q [ Time Frame: Post 12-months ] [ Designated as safety issue: No ]
  • Child Depression Inventory (CDI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Child Depression Inventory (CDI) [ Time Frame: Post 6-months ] [ Designated as safety issue: No ]
  • Child Depression Inventory (CDI) [ Time Frame: Post 12-months ] [ Designated as safety issue: No ]
  • PEDS QL [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • PEDS QL [ Time Frame: Post 6-months ] [ Designated as safety issue: No ]
  • PEDS QL [ Time Frame: Post 12-months ] [ Designated as safety issue: No ]
  • Moderate to Vigorous Physical Activity Measure (MVPA) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Moderate to Vigorous Physical Activity Measure (MVPA) [ Time Frame: Post 6-months ] [ Designated as safety issue: No ]
  • Moderate to Vigorous Physical Activity Measure (MVPA) [ Time Frame: Post 12-months ] [ Designated as safety issue: No ]
  • Sedentary Activity Checklist (SAC) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Sedentary Activity Checklist (SAC) [ Time Frame: Post 6-months ] [ Designated as safety issue: No ]
  • Sedentary Activity Checklist (SAC) [ Time Frame: Post 12-months ] [ Designated as safety issue: No ]
  • PACE +Fruit Vegetable Screening Measure (FVS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • PACE +Fruit Vegetable Screening Measure (FVS) [ Time Frame: Post 6-months ] [ Designated as safety issue: No ]
  • PACE +Fruit Vegetable Screening Measure (FVS) [ Time Frame: Post 12-months ] [ Designated as safety issue: No ]
  • PACE+ Dietary Fat Screening Measure (DFS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • PACE+ Dietary Fat Screening Measure (DFS) [ Time Frame: Post 6-months ] [ Designated as safety issue: No ]
  • PACE+ Dietary Fat Screening Measure (DFS) [ Time Frame: Post 12-months ] [ Designated as safety issue: No ]
  • Parent 24 Hour Dietary Recall [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Parent 24 Hour Dietary Recall [ Time Frame: Post 6-months ] [ Designated as safety issue: No ]
  • Parent 24 Hour Dietary Recall [ Time Frame: Post 12-months ] [ Designated as safety issue: No ]
  • Parent Overweight Status Height and weight (converted into BMI z-score) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Parent Overweight Status Height and weight (converted into BMI z-score) [ Time Frame: Post 6-months ] [ Designated as safety issue: No ]
  • Parent Overweight Status Height and weight (converted into BMI z-score) [ Time Frame: Post 12-months ] [ Designated as safety issue: No ]
  • Youth and Parent/Guardian Eating Questionnaire Y-EDE Q [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • Child Depression Inventory (CDI) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • PEDS QL [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • Moderate to Vigorous Physical Activity Measure (MVPA) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • Sedentary Activity Checklist(SAC) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • PACE +Fruit Vegetable Screening Measure (FVS) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • PACE+ Dietary Fat Screening Measure (DFS) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • Parent 24 Hour Dietary Recall [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • Parent Overweight Status Height and weight (converted into BMI z-score) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Parent-Based Treatment for Pediatric Overweight
Parent-Based Treatment for Pediatric Overweight

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Overweight
  • Obesity
  • 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
  • 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
  • Experimental: FBT-PO
    Family Based Therapy for Pediatric Overweight.
    Intervention: Behavioral: FBT-PO
  • Active Comparator: NEC
    Nutritional Educational Control Condition (NEC).
    Intervention: Behavioral: NEC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
August 2013
September 2012   (final data collection date for primary outcome measure)

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)
Both
13 Years to 17 Years
No
Contact: Terri L Bacow, Ph.D. (917) 710-0846 Terri.Bacow@mssm.edu
Contact: Kali Ludwig
United States
 
NCT00807560
GCO# 07-0216, 1R21HD057394-01
No
Mount Sinai School of Medicine
Mount Sinai School of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Katherine L Loeb, PH.D. Mount Sinai School of Medicine
Mount Sinai School of Medicine
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP