Project Summary
PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
One in five children in the United States has obesity, where a person’s weight is higher than the healthy range for his or her age, sex, and height. Children with obesity have an increased risk of mental and physical health problems, which can worsen their quality of life.
In this study, the research team is comparing the effectiveness of two approaches for treating obesity to see how well each approach helps children with obesity lose weight in one year. The first is a counseling approach called enhanced standard of care, or eSOC; the second approach is eSOC plus family-based behavioral therapy, or FBT.
Who can this research help?
Results may help doctors, children, and parents when considering how to prevent and treat childhood obesity.
What is the research team doing?
The research team is enrolling 1,296 children ages 6–15 who have obesity. Children are patients at clinics in Louisiana, Missouri, and New York. The team is assigning children by chance to one of two groups. Children in the first group take part in the eSOC program with their parents. The program includes at least six visits to a primary care doctor. At these visits, the doctor weighs the child and asks about his or her interest in making lifestyle changes. Using behavior change methods, the doctor suggests ways to eat healthier and do more physical activities. If the child responds well to care, the doctor suggests more ways to lose weight.
Children in the second group receive eSOC plus the FBT program. In the FBT program, children and their parents meet regularly with a health coach. The health coach provides advice on healthy eating, activity, positive parenting, and managing environmental cues.
The research team is reviewing medical records to see children’s weight, lipids, blood pressure, and blood sugar at the start of the study and one year later. At these same times, the team is also surveying children about their quality of life and how well they cope with bullying. The team is comparing these outcomes between the two groups and among groups of patients based on their race, ethnicity, and gender.
Children with obesity, their parents, primary care doctors, behavioral counselors, and health insurers help with this study. They help design the study and programs, choose outcomes, and provide ideas for recruiting study participants.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 1,296 children ages 6–15 years who have a body mass index ≥ the 95th percentile |
| Interventions/ Comparators |
|
| Outcomes |
Primary: children’s percentage overweight Secondary: quality of life, coping with bullying, blood pressure, lipids, HbA1c |
| 1-year follow-up for primary outcomes |