The Peds Obesity Study (NCT02353637) | Clinical Trial Compass
CompletedNot Applicable
The Peds Obesity Study
United States12 participantsStarted 2014-11
Plain-language summary
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.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 med…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement in BMI-Z Scores
Timeframe: 12 months
2
Weight Loss
Timeframe: 12 months
3
Metabolic Abnormalities (Periodic labwork will be obtained over the 12 month period to monitor metabolic abnormalities)