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Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00207519
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 11, 2009
Information provided by:
Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: weekly behavioral modification group Behavioral: liquid meal replacements Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2003
Actual Primary Completion Date : August 2004
Actual Study Completion Date : January 2009

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Include laboratory parameters such as lipids and HbA1c.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00207519

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United States, Massachusetts
Boston University Medical
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
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Principal Investigator: Caroline M Apovian, MD Boston University

Leighty J, Greve L, Hembrooke T, Hood K, Hughes T, O'Brien P, Warden N, Styne D. Alterations in nutrient intake in 6-10 year old, severely obese children following a 12-week family centered integrated treatment program. Pediatric Research. 2001;49:P3-758.
Styne D, Greve L, Hembrooke T, Hood K, Hughes T, Leighty J, O'Brien P, Warden N. Anthropomorphic and biochemical results of a family centered integrated treatment program for severely obese children. Pediatric Research. 2001;49:P3-757.
Brownell, KD. The LEARN Program for Weight Control. Dallas, TX: American Health Publishing: 1998.

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Responsible Party: Caroline Apovian, MD, Boston Medical Center Identifier: NCT00207519     History of Changes
Other Study ID Numbers: H-24640
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: February 2009
Keywords provided by Boston Medical Center:
Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms