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MedifastG?? Child & Adolescent Study: Frequently Asked Questions

Thank you again for your interest in the Take Shape for Life Child & Adolescent Weight Loss Study. We are currently finalizing arrangements to being recruiting participants later this summer. In the meantime, please read our answers to your most frequently asked questions, and donG??t hesitate to contact us if you have further concerns. We are looking forward to working with you soon.

1. What is the Take Shape for Life-Youth Study?

The Take Shape for Life- Youth Study (the Study) is an upcoming study that will evaluate whether the use of MedifastG?? meal replacements can aid with weight loss in overweight children and adolescents.

2. Who is eligible to participate in this study?

Children and adolescents between the ages of 8 and 18 years whose Body Mass Index percentile is at least 95% may be eligible to participate in this study. You may calculate your childG??s BMI percentile by visiting: http://apps.nccd.cdc.gov/dnpabmi/Calculator.aspx  Our staff will discuss specific criteria with you once we begin recruiting participants. You will be required to receive official permission from your physician in order to participate.

3. I have a client (or friend, or colleague) who would be interest in enrolling his/her child (or client, or patient)- is s/he eligible to participate?

Yes, any child interested in working with a TSFL Health Advisor on the Study, and meeting the study criteria, is eligible to participate. The principal investigators will make all final decisions regarding selection of participants.

4. If my child is already following a weight loss program, is s/he eligible to participate?

Children will not be eligible for participation if they have been following any weight loss plan, or using meal replacements for the purposes of weight loss, within 30 days of enrollment.

5. What does it cost to participate in this study?

Participants will pay for meal replacements up front. However, MedifastG?? will rebate a significant portion of the cost of meal replacements upon successful completion of the study protocol. More details will be provided once we begin recruiting participants.

6. How long will the study last?

The study will last a total of 9 months, divided into 2 phases: a 3-month weight loss phase, and a 6-month weight maintenance phase.

7. What kinds of foods will my child eat during this study?

Study participantsG?? meal plans will be designed by a registered dietitian, and will be dependent on age, gender, activity level, and nutritional requirements. The meal plans will be comprised of MedifastG?? meal replacements as well as whole foods. More details about the meal plans will be provided during the enrollment process. You will have a chance to evaluate the meal plans fully before deciding whether you wish to enroll in the Study.

Warmest Regards,

Dr. Wayne Andersen

Medical Director Medifast/TSFL

dra@sprynet.com

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