The Peds Obesity Study
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

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.
    

Detailed description: 
      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 University of Florida Health Pediatric
      Weight Management Center. Therefore, all these patients would have undergone a multifaceted
      assessment that is part of the standard of care at the University of Florida 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: Complete
      Blood Count, comprehensive metabolic panel, liver enzymes, thyrotropin, fasting plasma
      glucose and insulin levels, fasting lipid profile and urinalysis. In addition, as part of the
      standard of care at the University of Florida Pediatric Weight Management Center, patients
      and families complete the Obesity and Quality of Life questionnaires as well as the
      University of Florida Pediatric Weight Management Center Physical Activity questionnaire.
      Inclusion criteria include adolescents with primary obesity and a BMI≥ 99th percentile for
      age. Exclusion criteria include current diagnosis of Type II Diabetes Mellitus; gall bladder,
      liver or renal disorders; known eating disorders; known endocrine disorders such as
      hypothyroidism or polycystic ovary syndrome; pregnancy; genetic disorder, such as
      Prader-Willi Syndrome; mental retardation; severe depression; or use of any chronic
      medication that could impact appetite significantly. Patients with poor family support that
      might potentially preclude compliance with the study requirements will also be excluded.
      These diseases will be ruled out by means of medical history, physical examination and
      standard of care laboratory tests obtained on patients upon their entry to the University of
      Florida Health Pediatric Weight Management Center. A urine pregnancy test will be performed
      on female adolescents prior to enrolment in the study. Written informed consent will be
      obtained from the parent and assent from the adolescent.

      These patients will participate in a high protein, restricted carbohydrates utilizing partial
      meal replacements diet (HPRC-PMR) after obtaining consent to participate in the study.

      Behavioral counseling will be provided to all participants in the study. The behavior
      modification used as part of the standard of care at the University of Florida Health
      Pediatric Weight Management Center includes a combination of immediate, short-term, and
      long-term individual and family psychotherapy sessions to increase motivation to change diet
      and physical activity level. These treatments may also help children cope with the emotional
      stresses associated with being overweight and boost confidence especially within the school
      system. Obesity and Quality of Life survey will be completed by patients at baseline, and at
      3, 6 and 12 months after enrollment. (Permission to use this survey in the Center was
      obtained from Obesity and Quality of Life Consulting, Durham, North Carolina, and Children's
      Hospital Medical Center, OH). The survey includes questions regarding physical comfort, body
      esteem, social life and family relations.

      Patients on the HPRC-PMR diet will follow 4 phases. Please see attached table for details.

      The minimum amount of protein intake should be 1 g/Kg of protein/day. All meats and fish are
      permitted in this phase. Lean meats should be chosen. Patients will be encouraged to avoid
      hunger by having meals and 3 snacks throughout the day.

      Enrolled participants will have scheduled meetings with the dietitian. The schedule involves
      weekly meetings for the first 2 months, then every other week for additional 4 months,
      followed by monthly meeting for additional 6 months for each patient/family.

      Participants will be encouraged via the scheduled meetings with the dietitian to manage
      expected slip-ups. Minor, inconsequential slip-ups usually occur when the patient is not
      eating at home. In these cases, patients are encouraged to avoid carbohydrates, or starchy
      foods and desserts. In these cases, there will be no consequences, as long as these meals
      don't become a habit should go back to their regular diet the next day. A major diet slip-up
      is a big meal with all the trimmings. Patient will be encouraged to make up for a major diet
      slip-up the next day by avoiding all simple and complex carbohydrates for that one day only.

      All participants will be encouraged to have "break day" in the maintenance phase. It is a day
      where the patient goes "all-out" and enjoys whatever foods they feel like eating! Dieters who
      have struggled with his/her weight and beef, poultry, pork or veal in place of the meal
      replacement at lunch.
    

Intervention name(s): Partial Meal Replacements
Intervention type(s): Dietary Supplement
Intervention description(s): The use of partial meal replacements will be utilized in conjunction with a high protein, restricted carbohydrate diet
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science