Seattle Children’s is conducting a research study, the Familial Overweight: Comparing Use of Strategies (FOCUS) project, to learn more about how to help children and families struggling with overweight make better eating and activity choices that result in better weight management. The goal is to better understand different ways that might help families start and maintain healthy eating and activity behaviors.
Who can take part in the research study?
Eligible children and parents need to meet all the following study criteria:
- Child is 7 to 11 years old.
- One parent or caregiver and the child are English-speaking.
- At least one parent or caregiver is willing and able to actively participate in 20 weeks of treatment (treatment occurs in the evening).
- Child is at or above the 85th percentile for age- and gender-specific body mass index (BMI, which is weight in kilograms divided by the height in meters squared, or kg/m2), but not more than 175% above the median BMI for age and gender.
- At least one parent's BMI is greater than or equal to 25.
What is involved in the research study?
Families will participate in the following ways:
- Complete measurements of body composition (weight, height, waist circumference), diet and activity before receiving any treatment.
- Research staff will complete a one-to-two-hour home visit prior to treatment.
- Participate in 20 weekly, 60-to-75-minute family-based behavioral weight-control treatment sessions (including family and child/parent group sessions).
- Complete body composition measurements throughout and after treatment.
- Complete questionnaires before, during and after treatment.
- Do follow-up measurements, questionnaires and activity and eating assessments at three months and six months after the end of treatment.
We began pre-treatment activities in June 2008 and completed our first family treatment session in January 2009. Our second treatment session started in March 2009 and will be offering our final family treatment session in September 2009.
What are the benefits of taking part in this research study?
There are several potential benefits for children and caregivers. They may lose weight as part of the study. Children and parents often improve their eating and knowledge about eating. Increases in physical activity are also common. The information learned from this research study may benefit other individuals struggling with weight in the future. All families will receive an "active" treatment — there is no placebo or control condition (in which families would not receive a treatment), but we do not know which of the two approaches will be more effective. That is why we are doing the study.
Will participants be paid for their time?
All study activities, including assessments and treatment, are provided at no cost to families. In addition, families will receive a total of $55 for completing measurements and questionnaires over the 20 weeks of treatment, and an additional total of $45 for the questionnaires completed at three and six months following treatment. Parking and/or transit-fare passes for treatment visits are provided at no cost to families.
What are the risks of taking part in this research study?
The risks of this study are minimal. Children and caregivers may feel hungry from reducing intake and may get injured from increasing physical activity.
Will my information from the study be kept confidential?
Information that you and your child provide will be kept strictly confidential to the extent allowed by law. All data provided will be computer-entered by code number, not name. So, every participant will be given a number and names will not be associated with any data.
What rights do research participants have?
Taking part in research is voluntary. Children and caregivers may decide not to take part. If they do take part, they can withdraw from the study at any time and this will not affect care at Seattle Children’s.
How much time will it take to participate in this research study?
The assessment visits (before treatment, at the end of treatment, at a three-month follow-up and at a six-month follow-up) take from 90 minutes to two hours, with some additional time before treatment to go through the consent process. Seven home assessment visits, which take 30 to 60 minutes, are also scheduled throughout treatment and follow-up. The 20 weekly treatment visits last between 60 and 75 minutes per visit.
What happens after the research study is over?
We share all of the information about a family's changes that we measure (such as eating, activity, weight) with the family during and after their participation. During the consent/assent process, we ask parents to sign a release of information (ROI) form that will allow us to contact the child's pediatrician and the parents' own doctor about their participation. If the parents sign the ROI and would like us to, we will share the information about the family's measures taken over the course of the study with the pediatrician or family doctor.
Why is this research study important?
This study is being done to compare two different behavioral treatment approaches for weight management among children and parents who are overweight or at risk of becoming overweight. The study also looks at the effectiveness of behavioral treatment overall and examines whether a treatment works better or worse for some families.
Who is funding this research study?
This study is funded by the National Institutes of Health (NIH).
Where does the research study take place?
Families will be screened on the telephone for eligibility. If eligible and interested, families will take part in assessments at home and at the West 8th building in downtown Seattle (2001 Eighth Avenue). Treatment will be conducted at the Seattle Children’s Research Institute at the West 8th building in downtown Seattle.
Are there any costs to participate in this study?
All study activities, including assessments and treatment, are provided at no cost to families. Parking and/or transit-fare passes for treatment visits are provided at no cost to families.