Seattle Children's, the University of Washington and Washington University in St. Louis are conducting a research study, the Comprehensive Maintenance Program to Achieve Sustained Success (COMPASS), to learn more about the best type of treatment for long-term weight management in overweight children and their families. The goal is to better understand the relationship between duration of treatment and long-term maintenance of healthy behavior changes.
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 up to 48 weeks of treatment (treatment occurs on weekday evenings)
- Child is at or above the 85th percentile for age- and gender-specific body mass index (BMI is weight in kilograms divided by height in meters squared, or kg/m2)
- At least one parent's BMI is greater than 25
What is involved in the research study?
Families will participate in the following ways:
- Complete measurements of body composition (weight, height and waist circumference), diet and activity before receiving any treatment
- Participate in 16 weekly 60-to-75-minute family-based behavioral weight control treatment sessions over the course of 4 months
- After the first 4 months of weekly treatment, all families will be randomly assigned to continue to meet every week or meet every other week for the remaining 8 months of treatment
- Complete body composition, diet and activity measurements throughout treatment, and at 6 months and 12 months following treatment
Pre-treatment activities began in late November 2009, and our first family treatment session began in April 2010. Our second treatment session will begin in mid-August 2010.
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 approaches will be the most 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 $50 for completing measurements and questionnaires over the course of treatment, and an additional total of $175 for the questionnaires and measurements completed at 6 and 12 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 making changes to their eating and may feel sore from increasing physical activity.
Will my information from the study be kept confidential?
Information provided will be kept strictly confidential to the extent allowed by law. Every participant will be given a number so that names will not be associated with any data. All data provided will be computer-entered by code number, not name.
Data will be stored in locked file cabinets and protected computer files at our laboratories at Seattle Children’s and the University of Washington. Only the investigators and research assistants associated with this study and Children’s Institutional Review Board (a committee that protects the rights and welfare of children and families who participate in research activities) will have access to this information. Information from participants will be combined when presenting results so that no one’s individual information will be seen.
What rights do research participants have?
Participation in this study is voluntary. Any decision to participate will not influence participants’ future relations or care with Seattle Children’s or the University of Washington. Participants are free to withdraw their participation at any time without penalty.
How much time will it take to participate in this research study?
Families will be in the research study for about two years. Families attend either 32 or 48 treatment session (depending on random group assignment) over the course of 48 weeks. Each treatment visit lasts approximately 75 minutes per visit. The assessment visits (before treatment, at the end of treatment, at a 6-month and 12-month follow-up) take from 90 minutes to 2.5 hours.
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 and 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.
Study results will be published with any names or other identifying information removed. Interested participants can request a summary of the study results to be sent to them in the mail.
Why is this research study important?
This study is being done to find out more about the best type of treatment for long-term weight management in overweight children and their families. This study aims to learn more about how long treatment should last, how often it should occur and what type of treatment works best.
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 over the telephone for eligibility. If eligible and interested, families will take part in assessments at the West 8th building in downtown Seattle (2001 Eighth Avenue) and at the University of Washington Medical Center. Treatment will be conducted at the Seattle Children's Research Institute at the Met Park West building in downtown Seattle.
Are there any costs to participate in this study?
No. There are no costs to participate in this study.