Status:
COMPLETED
Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents
Lead Sponsor:
Boston Medical Center
Conditions:
Overweight
Obesity
Eligibility:
All Genders
12-18 years
Phase:
PHASE1
Brief Summary
In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight" (i.e., a BMI/age \>85th percentile) a structured meal plan consisting of meal replacements, fruits, vegetables...
Detailed Description
In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight" (i.e., a BMI/age \>85th percentile), a structured meal plan consisting of meal replacements, fruits, vegetable...
Eligibility Criteria
Inclusion
- BMI \>85th% for age and sex
- Weight gain over the last 6 months of \>5% than expected on the growth curve
- 12-17 years of age
Exclusion
- Subjects with intolerance to dairy products (e.g., lactose intolerance) will be excluded from entering into the study.
- Subjects must not have a history of clinically significant cardiac disease, congenital heart disease, any clinically significant abnormal cardiac condition, or be known to have a clinically significantly abnormal ECG. Specifically excluded conditions include coronary artery disease, clinically significant cardiac arrhythmias, and congestive heart failure.
- Subjects must not have a history of anorexia nervosa, untreated hypothyroidism (TSH greater than 4.0 mU/L for a second generation test), malignancy, pathophysiologic or genetic syndromes associated with obesity (i.e., Cushing's syndrome, Turner's syndrome, Prader Willi syndrome), major psychiatric illness such as bi-polar disorder, ADD, major depression, bulimia, schizophrenia, or psychosis.
- Subjects may not participate in any weight management program, except for that in this study, during this pilot. Subjects may not use prescription or over-the-counter (or herbal) weight control medication during the trial.
- Subjects must not have a history of alcohol or drug addiction or substance abuse within the previous 2 years.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00207519
Start Date
April 1 2003
End Date
January 1 2009
Last Update
February 11 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Boston University Medical
Boston, Massachusetts, United States, 02118