Parent-Based Treatment for Pediatric Overweight (PO)
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FBT-PO
NEC
Sponsored by

About this trial
This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, Adolescents, Family Therapy
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)
Sites / Locations
- The University of Chicago
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FBT-PO
NEC-control
Arm Description
Family Based Therapy for Pediatric Overweight.
Nutritional Educational Control Condition (NEC).
Outcomes
Primary Outcome Measures
BMI Z Score
Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html).
BMI Z Score
Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html)
Secondary Outcome Measures
Percent Completion
Percent of participants who completed the trial to assess feasibility and retention in the trial
Waist Measurement
Waist measurement in inches. This is not a primary outcome variable.
Waist Measurement
Waist measurement in inches. This is not a primary outcome variable.
Hip Measurement
Hip measurement in inches. This is not a primary outcome variable.
Hip Measurement
Hip measurement in inches. This is not a primary outcome variable.
Height
This variable informs the calculation of the outcome variable of BMI Z score.
Height
This variable informs the calculation of the outcome variable of BMI Z score.
Weight
This variable informs the calculation for the outcome variable of BMI Z score.
Weight
This variable informs the calculation of the outcome variable of BMI z score.
BMI
Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score.
BMI
Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.
BMI Percentile
Body Mass Index percentile. This is not a primary outcome variable.
BMI Percentile
Body Mass Index percentile. This is not a primary outcome variable.
Full Information
NCT ID
NCT00807560
First Posted
December 11, 2008
Last Updated
December 2, 2015
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00807560
Brief Title
Parent-Based Treatment for Pediatric Overweight
Acronym
PO
Official Title
Parent-Based Treatment for Pediatric Overweight
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, Adolescents, Family Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FBT-PO
Arm Type
Experimental
Arm Description
Family Based Therapy for Pediatric Overweight.
Arm Title
NEC-control
Arm Type
Active Comparator
Arm Description
Nutritional Educational Control Condition (NEC).
Intervention Type
Behavioral
Intervention Name(s)
FBT-PO
Other Intervention Name(s)
Family Based Therapy for Pediatric Overweight
Intervention Description
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
Intervention Name(s)
NEC
Other Intervention Name(s)
Nutritional Educational Control Condition
Intervention Description
Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.
Primary Outcome Measure Information:
Title
BMI Z Score
Description
Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html).
Time Frame
baseline
Title
BMI Z Score
Description
Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html)
Time Frame
up to 44 weeks
Secondary Outcome Measure Information:
Title
Percent Completion
Description
Percent of participants who completed the trial to assess feasibility and retention in the trial
Time Frame
at 44 weeks
Title
Waist Measurement
Description
Waist measurement in inches. This is not a primary outcome variable.
Time Frame
baseline
Title
Waist Measurement
Description
Waist measurement in inches. This is not a primary outcome variable.
Time Frame
up to 44 weeks
Title
Hip Measurement
Description
Hip measurement in inches. This is not a primary outcome variable.
Time Frame
baseline
Title
Hip Measurement
Description
Hip measurement in inches. This is not a primary outcome variable.
Time Frame
up to 44 weeks
Title
Height
Description
This variable informs the calculation of the outcome variable of BMI Z score.
Time Frame
Baseline
Title
Height
Description
This variable informs the calculation of the outcome variable of BMI Z score.
Time Frame
up to 44 weeks
Title
Weight
Description
This variable informs the calculation for the outcome variable of BMI Z score.
Time Frame
baseline
Title
Weight
Description
This variable informs the calculation of the outcome variable of BMI z score.
Time Frame
up to 44 weeks
Title
BMI
Description
Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score.
Time Frame
baseline
Title
BMI
Description
Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.
Time Frame
up to 44 weeks
Title
BMI Percentile
Description
Body Mass Index percentile. This is not a primary outcome variable.
Time Frame
baseline
Title
BMI Percentile
Description
Body Mass Index percentile. This is not a primary outcome variable.
Time Frame
up to 44 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine L Loeb, PH.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
NY
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Parent-Based Treatment for Pediatric Overweight
We'll reach out to this number within 24 hrs