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Completed

NCT Number: NCT00807560

Parent-Based Treatment for Pediatric Overweight

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.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The University of Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FBT-PO

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.

Other names: Family Based Therapy for Pediatric Overweight

NEC

Behavioral

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

Other names: Nutritional Educational Control Condition

Primary outcomes

  1. BMI Z Score

    Time frame: baseline

    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).

  2. BMI Z Score

    Time frame: up to 44 weeks

    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 outcomes

  1. Percent Completion

    Time frame: at 44 weeks

    Percent of participants who completed the trial to assess feasibility and retention in the trial

  2. Waist Measurement

    Time frame: baseline

    Waist measurement in inches. This is not a primary outcome variable.

  3. Waist Measurement

    Time frame: up to 44 weeks

    Waist measurement in inches. This is not a primary outcome variable.

  4. Hip Measurement

    Time frame: baseline

    Hip measurement in inches. This is not a primary outcome variable.

  5. Hip Measurement

    Time frame: up to 44 weeks

    Hip measurement in inches. This is not a primary outcome variable.

  6. Height

    Time frame: Baseline

    This variable informs the calculation of the outcome variable of BMI Z score.

  7. Height

    Time frame: up to 44 weeks

    This variable informs the calculation of the outcome variable of BMI Z score.

  8. Weight

    Time frame: baseline

    This variable informs the calculation for the outcome variable of BMI Z score.

  9. Weight

    Time frame: up to 44 weeks

    This variable informs the calculation of the outcome variable of BMI z score.

  10. BMI

    Time frame: baseline

    Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score.

  11. BMI

    Time frame: up to 44 weeks

    Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.

  12. BMI Percentile

    Time frame: baseline

    Body Mass Index percentile. This is not a primary outcome variable.

  13. BMI Percentile

    Time frame: up to 44 weeks

    Body Mass Index percentile. This is not a primary outcome variable.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

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

Registry information

Acronym: PO

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 12, 2008
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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