Parent-Based Treatment for Pediatric Overweight - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

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

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	80
Study Start Date:	September 2008
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	September 2012 (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 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

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

Contacts

Contact: Terri L Bacow, Ph.D.	(917) 710-0846	Terri.Bacow@mssm.edu
Contact: Kali Ludwig

Locations

United States, Illinois
The University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Contact: Daniel le Grange, Ph.D. 773-702-9277 legrange@uchicago.edu
Contact: Kali Ludwig, BA (773) 702-0789 kludwig@bsd.uchicago.edu
Principal Investigator: Daniel le Grange, Ph.D.
Sub-Investigator: Angela Celio Doyle, Ph.D.
United States, New York
Mount Sinai School of Medicine	Recruiting
NY, New York, United States, 10029
Contact: Katherine L Loeb, Ph.D. 212-659-8724 Katharine.Loeb@mssm.edu
Contact: Teri L Bacow, Ph.D. (917) 710-0846 Terri.Bacow@mssm.edu
Principal Investigator: Katherine L Loeb, Ph.D.
Sub-Investigator: Thomas Hildebrandt, Psy.D.
Sub-Investigator: Danielle Laraque, MD

Sponsors and Collaborators

Mount Sinai School of Medicine

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Katherine L Loeb, PH.D.

Mount Sinai School of Medicine

More Information

Additional Information:

information about this study: Parent-Based Treatment for Pediatric Overweight This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00807560 History of Changes
Other Study ID Numbers:	GCO# 07-0216, 1R21HD057394-01
Study First Received:	December 11, 2008
Last Updated:	March 13, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:

Overweight
Obesity
Adolescents
Family Therapy

Additional relevant MeSH terms:

Obesity
Overweight
Overnutrition

Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013

Parent-Based Treatment for Pediatric Overweight (PO)