Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight"
      (i.e., a BMI/age >85th percentile) a structured meal plan consisting of meal replacements,
      fruits, vegetables, whole grains, lean protein and dairy products. We will encourage and
      invite at least one parent to the scheduled visits, however, no subject will be eliminated
      because of lack of parental involvement. In this study, we will conduct behavior modification
      group sessions using lessons which are structured and patterned after the suggestions
      documented in the LEARNÒ Program for Weight Control. Diet instruction by a registered
      dietitian will include the appropriate use of meal replacements for a low-fat, low-calorie
      meal plan. Portion sizes of all foods recommended will be reviewed and a structured meal plan
      will be developed by the dietitian for subjects to follow.

      Subjects will return on a weekly basis for behavioral modification groups sessions in
      conjunction with the liquid meal replacement diet. Blood work and physical examinations will
      occur pre and post intervention.
    

Detailed description: 
      In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight"
      (i.e., a BMI/age >85th percentile), a structured meal plan consisting of meal replacements,
      fruits, vegetables, whole grains, lean protein and dairy products. We will encourage and
      invite at least one parent to the scheduled visits, however, no subject will be eliminated
      because of lack of parental involvement. Parents will be encouraged to attend group sessions
      designed to include behavior modification, nutrition education, physical activity
      recommendations, and food demonstrations as a means of family support for the subject. In
      this study, we will conduct behavior modification group sessions using lessons which are
      structured and patterned after the suggestions documented in the LEARN Program for Weight
      Control. Diet instruction by a registered dietitian will include the appropriate use of meal
      replacements for a low-fat, low-calorie meal plan. Portion sizes of all foods recommended
      will be reviewed and a structured meal plan will be developed by the dietitian for subjects
      to follow. Subjects will return for 12 weekly group sessions.

      For the purposes of this pilot study, mild hypertension is defined as a systolic blood
      pressure of >130 but <140 mm Hg and a diastolic blood pressure of >85 but <90 mm Hg.
      Dyslipidemia will be defined as a total cholesterol of >200 mg/dl, LDL >130 mg/dl, HDL <40
      mg/dl for male subjects and <50 mg/dl for female subjects, and triacylglycerol of >150 mg/dl.
      Insulin resistance/diabetes shall be defined as a fasting glucose of >110 mg/dl.

      Calculating Estimated Caloric Need:

      Total caloric needs for subjects with a BMI >85th% for age and sex shall be calculated using
      the Basal Energy Expenditure multiplied by an Activity Factor (for an estimate of total
      energy requirements), then subtracting 250-500 calories (to achieve a 0.5 to 1 pound weight
      loss per week). Basal Energy Expenditure will be calculated by using the Harris-Benedict
      equation as follows:

      Females = 655 + 4.4(wt. in lbs) + 4.3(ht. in inches) - 4.7(age in yrs) x AF Males = 66 +
      6.2(wt. in lbs) +12.7(ht. in inches) - 6.8(age in yrs) x AF

      Activity Factors (AF):

      1.1 Restricted Activity 1.2 Sedentary (most commonly used) 1.3 Cardiovascular Activity 3x/wk

      Ideal body weight is defined as:

      Females = 100 lb for the first 5 ft + 5 lb for each inch over 5 ft Males = 106 lb for the
      first 5 ft + 6 lb for each inch over 5 ft

      Subjects will be prescribed a meal plan consisting of 3 meals and 2 snacks per day. However,
      2 of the 3 meals will be replaced with a liquid meal replacement which contains 220 kcal, 10
      g. protein, 40 g. carbohydrate, 2.5-3 g. fat, and 5 g. dietary fiber as well as vitamin and
      mineral fortification. The third meal will be high in fruits, vegetables, whole grains, lean
      protein (30-45 g/day) and contain 600-900 kcal. Low-calorie snacks, to include additional
      fruit servings, will be encouraged. The meal replacements will be taken at a time the subject
      will be most compliant, i.e., if subject is a chronic breakfast skipper, a meal replacement
      will be added for the breakfast meal. All meal replacements will be provided to the subjects
      at no cost; subjects will complete an order form at each visit indicating flavor choices of
      vanilla, chocolate or strawberry for the liquid meal replacements. They will be offered the
      option of a meal replacement bar versus liquid meal replacement for only one of the meal
      replacements per day (220 kcal, 8 g. protein, 36 g. carbohydrate, 2 g. dietary fiber). These
      will be a choice of chocolate peanut or granola/fruit bars.

      To identify and encourage dietary compliance, subjects will be provided with a food record
      and will be instructed to complete 3 food records per week, two week days and one weekend
      day, and to indicate the time of day and which type of meal replacement was consumed. This
      indication will be helpful in dietary instruction regarding time of day compliance is best
      for consuming the meal replacement. Subjects will also be instructed to return any unused
      meal replacements and labels from consumed meal replacements at their regularly scheduled
      visits as further identification of compliance to diet. A validated Youth and Adolescent Food
      Frequency Questionnaire or Adolescents Food Habits Checklist will be obtained at the
      beginning and end of the pilot study. Blood work and a physical exam will be performed pre
      and post intervention.
    

Intervention name(s): weekly behavioral modification group; liquid meal replacements
Intervention type(s): Behavioral; Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overweight; obesity; adolescent