Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents

This study has been completed.
Sponsor:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00207519
First received: September 13, 2005
Last updated: February 10, 2009
Last verified: February 2009
  Purpose

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 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

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

Estimated Enrollment: 40
Study Start Date: April 2003
Study Completion Date: January 2009
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
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  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00207519

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

Publications:
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.

Responsible Party: Caroline Apovian, MD, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00207519     History of Changes
Other Study ID Numbers: H-24640
Study First Received: September 13, 2005
Last Updated: February 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
overweight
obesity
adolescent

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014