What is the purpose of this study?
The goal of LAUNCH is to partner with families to develop a program that will promote healthy child growth. As part of this goal, LAUNCH is inviting families of preschool-aged children who are at the higher end of the growth curve to participate in a study to help understand the relationship between patterns of growth and health in preschoolers.
The primary goal of LAUNCH is to learn whether preschool children who are at the higher end of the growth curve can benefit from treatment or if they will outgrow this percentile as they grow in height.
Who can participate?
Preschool children, ages 2-5, at the upper end of the growth curve for body mass index (≥ 95%) without a diagnosed medical or developmental condition precluding participation.
Participation in this study is by invitation only.
What is involved?
Families who agree to participate will be randomly assigned to one of three groups. Randomly assigned means families will be assigned to a group by chance, like flipping a coin. The three possible groups are:
- In-Person Nutrition and Activity Intervention. Families assigned to this group will be asked to attend 12 weekly sessions that will alternate between clinic visits with other families and individual home visits. Each clinic visit will last 90 minutes and home visits will last 60 minutes. After that, for the next 12 weeks families will be asked to meet bi-weekly, still alternating between clinic and home visits. LAUNCH makes every effort to hold group clinic sessions at a location convenient to the families attending, and to schedule home visits at the family’s convenience. See sample in-person group schedule here.
- Telephone Nutrition and Activity Intervention. Families assigned to this group will also have 12 weekly sessions followed by 12 weeks of bi-weekly sessions however, most of the sessions will occur over the phone. The first session will be conducted at Cincinnati Children's and 3 sessions will occur in the family’s home. Each phone session will last less than 20 minutes and home visits will last 60 minutes. See sample telephone group schedule here.
- Usual Care Group. Families assigned to the usual care group will not have any additional visits. Families will complete only the assessment visits every 6 months. See Sample usual care group schedule here.
Families in all three groups will be asked to complete several measures to evaluate the study’s results. Measures are collected at four assessment periods occurring about every 6 months over the course of 18 months. At these visits, measurements such as your child's growth, food intake, and activity, parental satisfaction with treatment, and parental weight would be assessed. Families will be reimbursed for completing these assessment visits (see below)
What are the benefits?
Although there may not be a direct medical benefit your participation will help us know if treatment is necessary or helpful for preschool children at the upper end of the growth curve. If you agree to take part in this research study, potential benefits include an improved awareness of nutritional and physical activity for you and your child. Also, the information learned from this research study may improve future interventions for other preschool children, if we find the nutrition and activity education sessions are helpful.
Will I get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. It describes the study procedures, risks, benefits, compensation, 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/guardian has signed this form.
Do participants receive pay, compensation or reimbursement?
For each assessment visit, you will be given $50 for your time and effort. There will be four visits at Cincinnati Children's Hospital Medical Center including:
- Your first visit when you start the study
- Your six-month visit
- Your one-year follow-up visit
- Your eighteen-month follow up visit
- From 2 through 5 years old
Who should I contact for more information?
LAUNCH Study Coordinator
Cincinnati Children's Hospital Medical Center
Department of Behavioral Medicine and Clinical Psychology, MLC 3015
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Phone: (513) 636-7727