Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents

Completed · Phase 1

Conditions studied: Overweight, Obesity

In brief

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.

Key facts

Study ID

NCT00207519

Run by

Boston Medical Center

People needed

40

Starts

2003-04-01

Expected to finish

2009-01-01

Last updated by the study team

2009-02-11

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Boston University Medical — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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