Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents
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|ClinicalTrials.gov Identifier: NCT00207519|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 11, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: weekly behavioral modification group Behavioral: liquid meal replacements||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents: A 12 Week Safety and Efficacy Study|
|Study Start Date :||April 2003|
|Primary Completion Date :||August 2004|
|Study Completion Date :||January 2009|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207519
|United States, Massachusetts|
|Boston University Medical|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Caroline M Apovian, MD||Boston University|