Clinical trial NCT00207519: Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents
Official title: The Use of Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents: A 12 Week Safety and Efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Obesity
Keywords: overweight
obesity
adolescent
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Outcome measures include for efficacy of intervention, height, weight, BMI, waist circumference, percent body fat, height Z-score, weight Z-score, BMI-Z score, degree of change in weight Z-score, BMI Z-score, and percent body.
Secondary outcomes:
measure: Include laboratory parameters such as lipids and HbA1c.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical
state: Massachusetts
Study officials:
affiliation: Boston University
name: Caroline M Apovian, MD
role: PRINCIPAL_INVESTIGATOR
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