Plant-Based, American Heart Assoc. or Mediterranean Diets In 9-18 yo With BMI >95%, Cholesterol >169 and Their Parents
Condition: Obesity; Hypercholesterolemia; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Hypercholesterolemia
Study type: Interventional

Summary: 
      The purpose of this research is to investigate the effects of a PB no- added-fat and the AHA
      and MED in obese (BMI >95%) children ages 9-18 with hypercholesterolemia (>169 mg/dl) and a
      parent or guardian. Eligible patients will be identified by utilizing the Pediatric Obesity
      Registry. When possible, in-person discussions or phone calls with their primary or tertiary
      care physicians will introduce eligible patients and their parents to the study. All eligible
      patients and parents will receive letters describing the study and requesting their
      participation. Subjects can choose not to participate in the study, and their health care
      will not be affected in any way. Subjects not participating will be asked if they are willing
      to answer a brief questionnaire about why they chose not to participate. The proposed study
      will be carried out for a total of 52 weeks. The investigators expect to recruit a total of
      180 participants (30 children and 30 parents/guardians in each of the three groups). Each
      child and parent/guardian pair will be randomly assigned to either PB no-added-fat, AHA or
      MED.
    

Detailed description: 
      Background: There is a need to have effective lifestyle modifications that target the growing
      group of obese children with dyslipidemia. The beneficial health effects of plant-based (PB)
      diets in adults are known. Studies have suggested that a low-fat vegan diet (no animal
      products) may promote weight loss, lower body mass index (BMI), and improve lipoprotein
      profiles and insulin sensitivity and possibly prevent cardiovascular disease (CVD).1-5 Those
      who follow a vegetarian diet(no animal products except for dairy and/or eggs) typically have
      lower cholesterol levels and a lower risk for heart disease than non-vegetarians.6-8
      Additionally, vegetarian diets have been shown to not only prevent but reverse heart disease
      in adults.9-11 The three major diets emphasized in the 2015 United States Dietary Guidelines
      are a Plant-based Diet (PB), and the American Heart Association-like Diet (AHA) and
      Mediterranean Diet (MED).(11) Similar to the PB, the AHA diet encourage fruits, vegetables,
      whole grains, and low sodium intake but permits non-whole grains, low-fat dairy, selected
      plant oils, and lean meat and fish in moderation. The MED, is similar to AHA with more
      emphasis on fish and extra virgin olive oil and/or nuts).

      Study Aims: The primary aim of this study is to determine whether a PB and/or AHA and/or MED
      diets significantly change anthropometric measurements and/or biomarkers of CVD risk after a
      4 and 52-week intervention in obese children with hypercholesterolemia ages 9-18 years and
      one of their parents. The investigators also aim to prospectively determine for the first
      time in children and adults if there are significant outcome differences between the three
      diets highlighted in the 2015 U.S. Dietary Guidelines.

      Protocol Summary The purpose of this research is to investigate the effects of a PB no-
      added-fat and the AHA and MED in obese (BMI >95%) children ages 9-18 with
      hypercholesterolemia (>169 mg/dl) and a parent or guardian. Eligible patients will be
      identified by utilizing the Pediatric Obesity Registry. When possible, in-person discussions
      or phone calls with their primary or tertiary care physicians will introduce eligible
      patients and their parents to the study. All eligible patients and parents will receive
      letters describing the study and requesting their participation. Subjects can choose not to
      participate in the study, and their health care will not be affected in any way. Subjects not
      participating will be asked if they are willing to answer a brief questionnaire about why
      they chose not to participate. The proposed study will be carried out for a total of 52
      weeks. The investigators expect to recruit a total of 180 participants (30 children and 30
      parents/guardians in each of the three groups). Each child and parent/guardian pair will be
      randomly assigned to either PB no-added-fat, AHA or MED.

      Procedures of the study:

      Eligible patients and parent/guardian pairs who are interested in participating in the study
      will have an initial phone call with the study team to answer any questions regarding the
      study. Informed consent, or assent for children under age 18, will then be obtained by study
      team investigators face-to-face with the parent/guardian and child pairs prior to the start
      of the study at a mutually convenient time and place at Cleveland Clinic Regional and Main
      Campus sites. Patient and parent/guardian pairs will be randomized to one of the three diets
      at the first study visit.

      Throughout the 52 week diet study, participants will be asked to attend group sessions held
      on Saturdays during weeks 0, 1, 2, 3, 4, and 52 to learn about their assigned diets and
      receive support for their efforts. There will Saturday support sessions during weeks 6, 10,
      16, 24, 34, and 46 and support phone calls every 2 weeks.

      The participants will also provide 24 hour dietary recalls of 2 weekdays and 1 weekend day on
      three time points: before the first study visit, between weeks 2 and 4, and then between
      weeks 48 and 52.

      Participants will have fasting blood tests to assess biomarkers of cardiovascular risk and
      anthropometric measurements will be performed weeks 0, 4, and 52. Stool and urine specimens
      will be obtained for possible future testing for microbiome, genomic data and markers of
      cardiovascular risk at weeks 0, 4, and 52.
    

Intervention name(s): Plant-Based Diet; American Heart Association Diet; Mediterranean Diet
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention