Parent-Based Treatment for Pediatric Overweight

Study Overview
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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.

Official Title
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Parent-Based Treatment for Pediatric Overweight

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: FBT-PO
* Behavioral: NEC


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FBT-PO<br>Family Based Therapy for Pediatric Overweight. | Behavioral: FBT-PO<br>* 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.<br>* Other names: Family Based Therapy for Pediatric Overweight;|
| Active Comparator: NEC-control<br>Nutritional Educational Control Condition (NEC). | Behavioral: NEC<br>* Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.<br>* Other names: Nutritional Educational Control Condition;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Completion | Percent of participants who completed the trial to assess feasibility and retention in the trial | at 44 weeks | 
| Waist Measurement | Waist measurement in inches. This is not a primary outcome variable. | baseline | 
| Waist Measurement | Waist measurement in inches. This is not a primary outcome variable. | up to 44 weeks | 
| Hip Measurement | Hip measurement in inches. This is not a primary outcome variable. | baseline | 
| Hip Measurement | Hip measurement in inches. This is not a primary outcome variable. | up to 44 weeks | 
| Height | This variable informs the calculation of the outcome variable of BMI Z score. | Baseline | 
| Height | This variable informs the calculation of the outcome variable of BMI Z score. | up to 44 weeks | 
| Weight | This variable informs the calculation for the outcome variable of BMI Z score. | baseline | 
| Weight | This variable informs the calculation of the outcome variable of BMI z score. | up to 44 weeks | 
| BMI | Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score. | baseline | 
| BMI | Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score. | up to 44 weeks | 
| BMI Percentile | Body Mass Index percentile. This is not a primary outcome variable. | baseline | 
| BMI Percentile | Body Mass Index percentile. This is not a primary outcome variable. | up to 44 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obesity, Adolescents, Family Therapy