Parent-Based Treatment for Pediatric Overweight

Obesity Clinical Trial

— PO  

Official title:

Parent-Based Treatment for Pediatric Overweight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807560
• Other study ID #: GCO 07-0216
• Secondary ID: 1R21HD057394-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 11, 2008
• Last updated: December 2, 2015
• Start date: September 2008
• Est. completion date: June 2013

Study information

• Verified date: December 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois
United States	Icahn School of Medicine at Mount Sinai	NY	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline	No
Primary	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)	up to 44 weeks	No
Secondary	Percent Completion	Percent of participants who completed the trial to assess feasibility and retention in the trial	at 44 weeks	No
Secondary	Waist Measurement	Waist measurement in inches. This is not a primary outcome variable.	baseline	No
Secondary	Waist Measurement	Waist measurement in inches. This is not a primary outcome variable.	up to 44 weeks	No
Secondary	Hip Measurement	Hip measurement in inches. This is not a primary outcome variable.	baseline	No
Secondary	Hip Measurement	Hip measurement in inches. This is not a primary outcome variable.	up to 44 weeks	No
Secondary	Height	This variable informs the calculation of the outcome variable of BMI Z score.	Baseline	No
Secondary	Height	This variable informs the calculation of the outcome variable of BMI Z score.	up to 44 weeks	No
Secondary	Weight	This variable informs the calculation for the outcome variable of BMI Z score.	baseline	No
Secondary	Weight	This variable informs the calculation of the outcome variable of BMI z score.	up to 44 weeks	No
Secondary	BMI	Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score.	baseline	No
Secondary	BMI	Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.	up to 44 weeks	No
Secondary	BMI Percentile	Body Mass Index percentile. This is not a primary outcome variable.	baseline	No
Secondary	BMI Percentile	Body Mass Index percentile. This is not a primary outcome variable.	up to 44 weeks	No

External Links

•   information about this study: Parent-Based Treatment for Pediatric Overweight