Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents
Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents
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.
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.
Inclusion Criteria:

 -  BMI >85th% for age and sex

 -  Weight gain over the last 6 months of >5% than expected on the growth curve

 -  12-17 years of age

 Exclusion Criteria:

 -  Subjects with intolerance to dairy products (e.g., lactose intolerance) will be
 excluded from entering into the study.

 -  Subjects must not have a history of clinically significant cardiac disease, congenital
 heart disease, any clinically significant abnormal cardiac condition, or be known to
 have a clinically significantly abnormal ECG. Specifically excluded conditions include
 coronary artery disease, clinically significant cardiac arrhythmias, and congestive
 heart failure.

 -  Subjects must not have a history of anorexia nervosa, untreated hypothyroidism (TSH
 greater than 4.0 mU/L for a second generation test), malignancy, pathophysiologic or
 genetic syndromes associated with obesity (i.e., Cushing's syndrome, Turner's
 syndrome, Prader Willi syndrome), major psychiatric illness such as bi-polar disorder,
 ADD, major depression, bulimia, schizophrenia, or psychosis.

 -  Subjects may not participate in any weight management program, except for that in this
 study, during this pilot. Subjects may not use prescription or over-the-counter (or
 herbal) weight control medication during the trial.

 -  Subjects must not have a history of alcohol or drug addiction or substance abuse
 within the previous 2 years.