This study will evaluate the impact a behavioral intervention can have on BMI. We 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.

Condition	Intervention
Obesity	Behavior: Education on exercise and nutrition; Exercise; Empowerment

Further Study Details: 

Primary Outcomes: The primary outcome will be improvement of BMI by 5 points in those in the intervention group.
Secondary Outcomes: The secondary outcomes will be improvement in fasting blood studies (fasting insulin, glucose, lipid panel)
Expected Total Enrollment:  30

This is a long term randomized controlled trial, looking at the impact of a behavioral intervention on BMI,in participants ages 10-20 with a BMI > 85%.

The intervention group will:

• have baseline and follow up blood work (fasting insulin, glucose, lipid panel)
• have baseline and follow up BMI, blood pressure measurements
• see a dietician-minimum of three visits during study

• attend monthly, four hour sessions. These sessions include:

  1. registration-monitoring of choices of liquid intake using standardized models, monitoring of sedentary behaviors-hours watching television, computer, video games, monitoring of heart rate at baseline and after exercise, monitoring of METs (metabolic equivalents), motivational interviewing, monitoring of exercise abilities (endurance, agility, curl ups, balance, power)
  2. one hour of exercise (including strength training)
  3. educational lectures on nutrition and the medical aspects of obesity and Type 2 diabetes epidemic
  4. projects/games
  5. empowerment tools such as leading exercises and presenting food labels for discussion

The control group will have:

1. baseline and follow up blood work (fasting insulin, glucose, lipid panel)
2. baseline and follow up BMI and blood pressure measurements
3. visits to dietician (minimum of three visits during study)
4. standard education on nutrition and exercise given during office visit with primary care doctor

Ages Eligible for Study:  10 Years   -   20 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Ages 10-20 years
• BMI>85%

Exclusion Criteria:

• Endocrine disorder
• On psychotropic medications

Please refer to this study by ClinicalTrials.gov identifier  NCT00132132

Shirley Gonzalez, MD      617-926-0114    shirleyg@massmed.org

Massachusetts
      Caritas St. Elizabeth''''s Medical Center, Boston,  Massachusetts,  02135,  United States; Recruiting

Study chairs or principal investigators

Shirley Gonzalez, MD,  Principal Investigator,  Caritas St. Elizabeth''''s Medical Center   

Study ID Numbers:  00203 (number assigned by IRB)
Last Updated:  August 18, 2005
Record first received:  August 17, 2005
ClinicalTrials.gov Identifier:  NCT00132132
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23