Clinical trial NCT00807560: Parent-Based Treatment for Pediatric Overweight
Official title: Parent-Based Treatment for Pediatric Overweight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Overweight
Obesity
Keywords: Overweight
Obesity
Adolescents
Family Therapy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-12-12
Enrollment: 77
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: BMI Z Score
timeFrame: baseline
measure: BMI Z Score
timeFrame: up to 44 weeks
Secondary outcomes:
measure: Percent Completion
timeFrame: at 44 weeks
measure: Waist Measurement
timeFrame: baseline
measure: Waist Measurement
timeFrame: up to 44 weeks
measure: Hip Measurement
timeFrame: baseline
measure: Hip Measurement
timeFrame: up to 44 weeks
measure: Height
timeFrame: Baseline
measure: Height
timeFrame: up to 44 weeks
measure: Weight
timeFrame: baseline
measure: Weight
timeFrame: up to 44 weeks
measure: BMI
timeFrame: baseline
measure: BMI
timeFrame: up to 44 weeks
measure: BMI Percentile
timeFrame: baseline
measure: BMI Percentile
timeFrame: up to 44 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: NY
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Katherine L Loeb, PH.D.
role: PRINCIPAL_INVESTIGATOR
References: