The Peds Obesity Study
Completed · Not applicable
Conditions studied: Pediatric Obesity
In brief
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.
Key facts
- Study ID
- NCT02353637
- Run by
- University of Florida
- People needed
- 12
- Starts
- 2014-11-01
- Expected to finish
- 2018-02-22
- Last updated by the study team
- 2018-06-19
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Florida Pediatric Weight Management Center — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
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