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.
Behavioral: weekly behavioral modification group
Behavioral: liquid meal replacements
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Use of Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents: A 12 Week Safety and Efficacy Study|
- 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.
- Include laboratory parameters such as lipids and HbA1c.
|Study Start Date:||April 2003|
|Study Completion Date:||January 2009|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207519
|United States, Massachusetts|
|Boston University Medical|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Caroline M Apovian, MD||Boston University|