Family-Based Treatment for Childhood Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
The investigators plan to implement a novel limited RED (high-energy-dense) food variety prescription within a 18-month FBT to examine its effect on 18-month body mass index (BMI). This will be the first randomized control trial to examine how habituation rate, assessed via salivary habituation, mediates reduction in RED food intake, overall energy intake, and reductions in BMI over time, as well as if baseline habituation rate is a behavioral phenotype that moderates BMI outcomes. One hundred fifty-six children aged 8 to 12 years at \> 85th percentile BMI will be randomized to one of two, 18-month interventions compared in our 6-month pilot study: FBT (family-based behavioral obesity treatment) or FBT+Variety. Child and adult caregiver assessments will occur at 0, 6, 12, and 18 months on anthropometrics, dietary intake (RED food variety, energy, and diet quality), habituation, and physical activity.
Who Is on the Research Team?
Hollie Raynor, PhD RD LDN
Principal Investigator
University of Tennessee Knoxville
Are You a Good Fit for This Trial?
This trial is for children aged 8-12 with a BMI over the 85th percentile and an adult caregiver in the household with a BMI over 25 kg/m2. Both must live together full-time, be able to walk two blocks without stopping, not have had or plan bariatric surgery within certain time frames, and not be pregnant or planning pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive family-based behavioral obesity treatment (FBT) or FBT+Variety for 18 months, focusing on dietary intake, habituation, and physical activity
Follow-up
Participants are monitored for changes in BMI, dietary intake, and habituation after the treatment phase
What Are the Treatments Tested in This Trial?
Interventions
- FBT
- FBT+Variety
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Tennessee, Knoxville
Lead Sponsor
The Miriam Hospital
Collaborator
University at Buffalo
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Memphis
Collaborator