Status:
COMPLETED
An 18-month Trial of a Low Glycemic Load Diet
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Charles H. Hood Foundation
Conditions:
Obesity
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
The primary aim of this study is to compare the effects of an experimental low-glycemic load diet with those of a conventional low-fat diet among obese young adults in an 18-month randomized-controlle...
Detailed Description
The prevalence of obesity has risen dramatically among children in the U.S. since the 1960s. Effective treatment of childhood obesity is widely recognized as instrumental to public health efforts to c...
Eligibility Criteria
Inclusion
- Age 18 to 35 years
- Body mass index (BMI) ≥ 30 kg/m2
- Access to a working telephone
- Conversant in English
- Written medical clearance from a primary care physician or nurse practitioner, ruling out any pre-existing or complicating medical condition
Exclusion
- Body weight \>300 lbs
- Major medical illness (heart, kidney or liver disease; diabetes; cancer; endocrinopathy; psychiatric illness) or other active medical problem
- An obesity-associated genetic syndrome (e.g., Prader-Willi)
- An abnormal screening laboratory test (ALT, creatinine, BUN, hematocrit)
- Fasting blood glucose ≥ 126 mg/dl)
- Taking any prescription medication that affects body weight (glucocorticoids, neuropsychiatric agents), blood pressure, or serum cholesterol concentrations
- Currently smoking (1 cigarette during any of the last 7 days)
- Previous diagnosis of an eating disorder (anorexia nervosa, bulimia, binge-eating disorder)
- If female, not pregnant or planning to become pregnant in the next 18 months and not lactating
- Failure to complete the pre-enrollment visits
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00130299
Start Date
July 1 2004
End Date
December 1 2006
Last Update
August 30 2010
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115