Pediatric Obesity Clinical Trial
Official title:
Partial Meal Replacements Providing High Protein, Restricted Carbohydrates in the Treatment of Adolescents With Severe Obesity: A Randomized Controlled Trial
Verified date | June 2018 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to investigate, in severely obese adolescents, the effects of a high protein, restricted carbohydrates utilizing partial meal replacements diet (HPRC-PMR) on weight loss, body composition, and bio-chemical markers of lipid metabolism, insulin resistance, and inflammation over a 12 months period.
Status | Completed |
Enrollment | 12 |
Est. completion date | February 22, 2018 |
Est. primary completion date | February 22, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Severely obese adolescents (13 to 17 year old males and post-menarcheal females between the ages of 12 and 17) will be recruited through the UF Health Pediatric Weight Management Center. - All patients would undergo a multifaceted assessment that is part of the standard of care at the UF Pediatric Weight Management Center. (This includes a behavioral assessment conducted by the Center's psychologist, a detailed medical history and physical examination as well as a comprehensive laboratory testing to investigate for obesity comorbidities as indicated clinically for the individual patient. These laboratory tests include but not limited to the following: CBC, comprehensive metabolic panel, liver enzymes, thyrotropin, fasting plasma glucose and insulin levels, fasting lipid profile and urinalysis.) - As part of the standard of care at the UF Pediatric Weight Management Center, patients and families complete the IWQOL (Obesity and Quality of Life) questionnaires as well as the UF Pediatric Weight Management Center Physical Activity questionnaire. - Adolescents with primary obesity and a BMI= 99th percentile for age. Exclusion Criteria: - Current Diagnosis of Type II Diabetes Mellitis - Gall Bladder, Renal or Liver Disorders - Known Eating Disorders - Known Endocrine Disorders (such as hyperthyroidism or polycystic ovary syndrome) - Pregnancy - Genetic disorder (such as Prader-Willi Syndrome) - Mental Retardation - Severe Depression - Use of any chronic medicine which could impact appetite |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida Pediatric Weight Management Center | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Ideal PRotein of America |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in BMI-Z Scores | BMI measurements will be taken at all appointments for 12 months to track improvement in BMI | 12 months | |
Primary | Weight Loss | Weigh will be obtained at each appointment to track weight loss of 12 months | 12 months | |
Primary | Metabolic Abnormalities (Periodic labwork will be obtained over the 12 month period to monitor metabolic abnormalities) | Periodic labwork will be obtained over the 12 month period to monitor metabolic abnormalities | 12 months |
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