Efficacy of Parent-Child Dieting Plans Incorporating Medifast Meal Replacements for Weight Loss

Completed · Not applicable

Conditions studied: Obesity

In brief

1. Does a joint parent-child dieting approach, as opposed to an individually-based approach, improve weight loss outcomes? 2. Is a diet which includes Medifast meal replacements as efficacious as a non-supplemented Food Guide Pyramid-based diet (reference diet) in achieving better adherence to the diet, initial weight loss, reduction in % body fat, and weight maintenance? 3. Does regular use of Medifast meal replacements, in conjunction with a Food Guide Pyramid-based diet, result in significantly better compliance, greater dietary satisfaction, dietary quality, and palatability than the reference diet? 4. Do children who have lost weight using Medifast meal replacements, as an adjunct to a Food Guide Pyramid-based diet, achieve health benefits compared to baseline values and are these health benefits greater than those obtained following the reference diet?

Key facts

Study ID: NCT00198744
Run by: Johns Hopkins Bloomberg School of Public Health
People needed: 80
Starts: 2004-06-01
Expected to finish: 2006-06-01
Last updated by the study team: 2005-09-20

Who can join

Age: 8 and older, up to 15. Sex: any. Healthy volunteers: accepted.

You may qualify if…

80 males and females between 8 and 15 years of age, who are overweight (> 25kg/m2 or BMI > 95th percentile on BMI-for-age growth charts) and desiring weight loss.
40 parents, male or female, with a BMI > 25 kg/m2 and desiring weight loss
Not using appetite-affecting medications (e.g. Prozac, Ritalin) unless on established and stable doses
Not using weight loss drugs or herbals (phentermine, sibutramine, orlistat, etc…)
Willing and able to comply with the protocol requirements
Child willing and able to give informed consent/assent
Parent or legal guardian willing and able to give informed consent
Parents must be willing and able to attend all sessions with the child. (One parent or legal guardian is mandatory, however, both are encouraged to attend.)
Have regular source of health care (e.g. pediatrician) and permission of primary care provider

You may not qualify if…

Uncontrolled or unstable use of medications
Chronic uncontrolled health problems (not including obesity, mild dyslipidemia, hypertension <160/95)
Bulimia, laxative abuse, substance abuse, alcohol intake > 10 drinks per week, or uncontrolled psychiatric disorder (major depression, bipolar disorder, etc…) as determined at screening
Breast-feeding or pregnant at screening (determined by serum pregnancy test when applicable)- If a pregnancy occurs during the protocol treatment will end and the pregnancy will be followed to term.
Child/family distress determined by assessment of family situation at screening
Food allergies, such as peanuts, to ingredients in Medifast products

Where it is running

Johns Hopkins Bloomberg School of Public Health — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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