The study will last for approximately 18 months and includes 1 screening visit and 12 study visits. If your child qualifies for this study after the initial screening, he/she will be randomized (put into one of two study groups by chance) to be part of one of two nutrition treatment study groups. Each study group will have a different focus. The following are some of the study procedures:
- Your child will:
- Have his/her medical chart reviewed for information such as date of CF diagnosis, weight, height, other nutrition status evaluations, prescription information, results from lung function tests, etc.
- Submit one stool sample at the screening visit
- Submit throat cultures and have skinfold, height and weight measurements similar to his/her regular CF visits
- Have a body scan called a DXA (lasts about 3 minutes)
- Will wear a small monitor to assess his/her physical activity
- You will:
- Be asked to record your child’s food and beverage intake
- Complete questionnaires about your child’s quality of life, mealtime behavior and family stress levels
- You and your child will attend regular study visits with a therapist
What are the benefits?
Potential benefits from participating in this study include the following:
- You and your child may improve your knowledge of CF treatment and nutrition.
- Your child’s nutrition may improve.
- Your family will be contributing to knowledge about the best approach to nutrition treatment for CF, which may benefit other patients with CF.
Will I get all the facts about the study?
You will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the reimbursements , who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent or guardian has signed this form and, if of age, the child has given at minimum, his/her verbal agreement.
What are the risks and discomforts of the study?
There is a slight risk from the very small amount of radiation exposure from the DXA body scan. The other assessment measures have been used with children, and with children with CF specifically, with no negative effects. Participation in the study involves time and effort with keeping diet diaries, your child wearing an activity monitor, attending treatment sessions, and answering questions which may bring some discomfort to you or your child. A detailed list of potential risks and discomforts will be provided to those interested in knowing more about this study.
What is the pay?
Families will receive up to $520 for study participation and be given a digital food scale and measuring cups
Who should I contact for more information?
FUN (Families Understanding Nutrition) Study Contact
Stephanie Sullivan
513-636-7735
Principal Investigator:
Scott Powers, PhD
Behavioral Medicine and Clinical Psychology
Cincinnati Children’s Hospital Medical Center
