N/A
N=30
Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00132132 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Change in BMI (Body Mass Index) — -0.74; 1.33; -0.18; 0.98 kg/m^2 — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral education program (Behavioral)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in BMI (Body Mass Index) |
-0.74; 1.33; -0.18; 0.98; -0.37; 1.28 | 0.03 sig |
| PRIMARY Percentage of Participants With BMI Reduction |
75; 23 | 0.02 sig |
Summary
This study will evaluate the impact a behavioral intervention can have on BMI. The researchers anticipate the intervention group will experience a decrease in BMI of approximately five points. The intervention group will be compared to a control group. This is a long term, randomized, controlled study. The behavioral intervention is conducted during a four hour monthly session. The behavioral intervention includes: exercise, education on medical aspects and nutrition, and empowerment.
Eligibility Criteria
Inclusion Criteria
- Ages 10-20 years
- BMI>85%
Exclusion Criteria
- Endocrine disorder
- On psychotropic medications
Data sourced from ClinicalTrials.gov (NCT00132132). 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.