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

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: NCT00198744
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
Medifast, Inc.
Information provided by:
Johns Hopkins Bloomberg School of Public Health

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 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?

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Medifast FIT! for Kids Behavioral: standard recommendations for dietary intake in children Behavioral: both diet plans with and without a parent dieting Not Applicable

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 diet group (3 supplements per day) plus food-based diet
  2. Reference diet group (Food Guide Pyramid-based diet)

Participants will be further randomly assigned to one of two parent-child approaches:

  1. Dieting child with one dieting parent
  2. Dieting child without dieting parent Although it is encouraged to have both parents involved in the child's care, only one parent will be permitted to be dieting as a part of the study along with the child so that we can more cleanly assess the effects of a parent dieting without confounding effects of some families having two parents dieting. Both groups will attend separate biweekly educational lessons during the weight loss phase (same curriculum and teacher). Data collection visits will occur at baseline, week 12, and transition. There are a total of 31 visits for a child participating in this study, and 30.for a parent participating by dieting with their child.

Transition Phase: Transition to a maintenance diet will be individually timed by participant attainment of goal "healthy" weight (BMI≤ 25) or week 26, whichever comes first.

Maintenance Phase: This phase will occur after completion of weight loss or between weeks 27 and 78 (12 months). Groups will attend separate educational lessons (same curriculum and teacher) once every 4 weeks. The Medifast group will reduce supplements to 2 per day with a larger portion of calories from whole foods. The reference diet group will remain on a food-based (no supplements) maintenance diet for the entire 52+ week maintenance period. Data collection visits will occur at weeks 26 and 52.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2004
Study Completion Date : June 2006

Primary Outcome Measures :
  1. Weight
  2. BMI

Secondary Outcome Measures :
  1. blood changes
  2. body composition
  3. psychometrics

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. 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.
  2. 40 parents, male or female, with a BMI > 25 kg/m2 and desiring weight loss
  3. Not using appetite-affecting medications (e.g. Prozac, Ritalin) unless on established and stable doses
  4. Not using weight loss drugs or herbals (phentermine, sibutramine, orlistat, etc…)
  5. Willing and able to comply with the protocol requirements
  6. Child willing and able to give informed consent/assent
  7. Parent or legal guardian willing and able to give informed consent
  8. 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.)
  9. Have regular source of health care (e.g. pediatrician) and permission of primary care provider

Exclusion Criteria:

  1. Uncontrolled or unstable use of medications
  2. Chronic uncontrolled health problems (not including obesity, mild dyslipidemia, hypertension <160/95)
  3. Bulimia, laxative abuse, substance abuse, alcohol intake > 10 drinks per week, or uncontrolled psychiatric disorder (major depression, bipolar disorder, etc…) as determined at screening
  4. 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.
  5. Child/family distress determined by assessment of family situation at screening
  6. Food allergies, such as peanuts, to ingredients in Medifast products

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): NCT00198744

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United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Medifast, Inc.
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Principal Investigator: Lawrence J Cheskin, MD Johns Hopkins Bloomberg School of Public Health
Layout table for additonal information Identifier: NCT00198744    
Other Study ID Numbers: MEDI2004-01
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 20, 2005
Last Verified: January 2005