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

NCT00198744 | Completed

• 1 other identifier: MEDI2004-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Does a joint parent-child dieting approach, as opposed to an individually-based approach, improve weight loss outcomes?
2. 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. 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. 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?

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Weight

• BMI

Secondary Outcomes (3)

• blood changes

• body composition

• psychometrics

Interventions

Medifast FIT! for Kids BEHAVIORAL

standard recommendations for dietary intake in children BEHAVIORAL

both diet plans with and without a parent dieting BEHAVIORAL

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Medifast, Inc.: collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Eating

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Lawrence J Cheskin, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2004
• Study Completion: June 1, 2006
• Last Updated: September 20, 2005

Record last verified: 2005-01

Locations

US (1)