Parent-Based Treatment for Pediatric Overweight

NCT ID: NCT00807560

Last Updated: 2016-01-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FBT-PO

Family Based Therapy for Pediatric Overweight.

Group Type EXPERIMENTAL

FBT-PO

Intervention Type BEHAVIORAL

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.

NEC-control

Nutritional Educational Control Condition (NEC).

Group Type ACTIVE_COMPARATOR

NEC

Intervention Type BEHAVIORAL

Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.

Interventions

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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.

Intervention Type BEHAVIORAL

NEC

Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.

Intervention Type BEHAVIORAL

Other Intervention Names

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Family Based Therapy for Pediatric Overweight Nutritional Educational Control Condition

Eligibility Criteria

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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)
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katherine L Loeb, PH.D.

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1R21HD057394-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 07-0216

Identifier Type: -

Identifier Source: org_study_id

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