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The Peds Obesity Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353637
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
Ideal PRotein of America
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Dietary Supplement: Partial Meal Replacements Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Partial Meal Replacements Providing High Protein, Restricted Carbohydrates in the Treatment of Adolescents With Severe Obesity: A Randomized Controlled Trial
Study Start Date : November 2014
Actual Primary Completion Date : February 22, 2018
Actual Study Completion Date : February 22, 2018

Arm Intervention/treatment
Active Comparator: Male High Protein, Restricted Carbo, Partial Meal Replacement
A high protein, restricted carbohydrates diet that utilizes partial meal replacements
Dietary Supplement: Partial Meal Replacements
The use of partial meal replacements will be utilized in conjunction with a high protein, restricted carbohydrate diet

Active Comparator: Female High Protein, Restricted Carbo, Partial Meal Replaceme
A high protein, restricted carbohydrates diet that utilizes partial meal replacements
Dietary Supplement: Partial Meal Replacements
The use of partial meal replacements will be utilized in conjunction with a high protein, restricted carbohydrate diet




Primary Outcome Measures :
  1. Improvement in BMI-Z Scores [ Time Frame: 12 months ]
    BMI measurements will be taken at all appointments for 12 months to track improvement in BMI

  2. Weight Loss [ Time Frame: 12 months ]
    Weigh will be obtained at each appointment to track weight loss of 12 months

  3. Metabolic Abnormalities (Periodic labwork will be obtained over the 12 month period to monitor metabolic abnormalities) [ Time Frame: 12 months ]
    Periodic labwork will be obtained over the 12 month period to monitor metabolic abnormalities



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353637


Locations
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United States, Florida
University of Florida Pediatric Weight Management Center
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
University of Florida
Ideal PRotein of America
Investigators
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Principal Investigator: Madeline Joseph, MD UFJP
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02353637    
Other Study ID Numbers: UFJ 2014-140
IRB201702423 ( Other Identifier: University of Florida )
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms