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Sponsored by: |
Boston Medical Center |
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Information provided by: | Boston Medical Center |
ClinicalTrials.gov Identifier: | NCT00207519 |
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 | Intervention | Phase |
---|---|---|
Overweight Obesity |
Behavioral: weekly behavioral modification group Behavioral: liquid meal replacements |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Use of Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents: A 12 Week Safety and Efficacy Study |
Estimated Enrollment: | 40 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | August 2004 |
Ages Eligible for Study: | 12 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Boston University Medical | |
Boston, Massachusetts, United States, 02118 |
Principal Investigator: | Caroline M Apovian, MD | Boston University |
Study ID Numbers: | H-24640 |
Study First Received: | September 13, 2005 |
Last Updated: | June 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00207519 |
Health Authority: | United States: Institutional Review Board |
overweight obesity adolescent |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |