Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207519
Status:
COMPLETED
Last Update Posted:
2009-02-11
First Post:
2005-09-13
Brief Title:
Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
The Use of Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents A 12 Week Safety and Efficacy Study
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this 3-month pilot study we will introduce to 40 adolescents at risk for overweight ie a BMIage 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
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 ie a BMIage 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 mgdl LDL 130 mgdl HDL 40 mgdl for male subjects and 50 mgdl for female subjects and triacylglycerol of 150 mgdl Insulin resistancediabetes shall be defined as a fasting glucose of 110 mgdl
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 05 to 1 pound weight loss per week Basal Energy Expenditure will be calculated by using the Harris-Benedict equation as follows
Females 655 44wt in lbs 43ht in inches - 47age in yrs x AF Males 66 62wt in lbs 127ht in inches - 68age in yrs x AF
Activity Factors AF
11 Restricted Activity 12 Sedentary most commonly used 13 Cardiovascular Activity 3xwk
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 25-3 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 gday 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 ie 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 granolafruit 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
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 mgdl LDL 130 mgdl HDL 40 mgdl for male subjects and 50 mgdl for female subjects and triacylglycerol of 150 mgdl Insulin resistancediabetes shall be defined as a fasting glucose of 110 mgdl
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 05 to 1 pound weight loss per week Basal Energy Expenditure will be calculated by using the Harris-Benedict equation as follows
Females 655 44wt in lbs 43ht in inches - 47age in yrs x AF Males 66 62wt in lbs 127ht in inches - 68age in yrs x AF
Activity Factors AF
11 Restricted Activity 12 Sedentary most commonly used 13 Cardiovascular Activity 3xwk
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 25-3 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 gday 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 ie 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 granolafruit 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None