Status:
COMPLETED
Efficacy of Parent-Child Dieting Plans Incorporating Medifast Meal Replacements for Weight Loss
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Medifast, Inc.
Conditions:
Obesity
Eligibility:
All Genders
8-15 years
Phase:
NA
Brief Summary
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 no...
Detailed Description
Weight Loss Phase: This phase will take place between week 0 and week 26 (6 months). Participants will be randomly assigned to one of two weight loss treatment groups: 1. Medifast meal replacement di...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00198744
Start Date
June 1 2004
End Date
June 1 2006
Last Update
September 20 2005
Active Locations (1)
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1
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205