Phase 2
N=77
Parent-Based Treatment for Pediatric Overweight
Overweight · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00807560 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: BMI Z Score — 2.3; 2.4 Z-score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- FBT-PO (Behavioral); NEC (Behavioral)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BMI Z Score |
2.2; 2.4 | — |
| PRIMARY BMI Z Score |
2.2; 2.4 | — |
| SECONDARY Percent Completion |
34.2; 28.2 | — |
| SECONDARY Waist Measurement |
41.7; 45.3 | — |
| SECONDARY Waist Measurement |
41.7; 45.3 | — |
| SECONDARY Hip Measurement |
47.3; 50.3 | — |
| SECONDARY Hip Measurement |
47.3; 50.3 | — |
| SECONDARY Height |
66.1; 64.8 | — |
| SECONDARY Height |
66.1; 64.8 | — |
| SECONDARY Weight |
213.3; 233.0 | — |
| SECONDARY Weight |
213.3; 233.0 | — |
| SECONDARY BMI |
34.5; 38.7 | — |
| SECONDARY BMI |
34.5; 38.7 | — |
| SECONDARY BMI Percentile |
98.3; 99.2 | — |
| SECONDARY BMI Percentile |
98.3; 99.2 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT00807560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.