83 Participants Needed

Family-Based Treatment for Childhood Obesity

HR
Overseen ByHollie Raynor, PhD RD LDN
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: The University of Tennessee, Knoxville
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

HR

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

BMI > 85th percentile
> 85th percentile BMI
I have an adult caregiver with a BMI over 25 willing to attend treatment meetings.
See 3 more

Exclusion Criteria

Do not have reliable internet access
Child or adult caregiver report allergies to lemon or lime juice (used in habituation measures)
Child is not able to read at a third-grade reading level
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive family-based behavioral obesity treatment (FBT) or FBT+Variety for 18 months, focusing on dietary intake, habituation, and physical activity

18 months
Assessments at 0, 6, 12, and 18 months

Follow-up

Participants are monitored for changes in BMI, dietary intake, and habituation after the treatment phase

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • FBT
  • FBT+Variety
Trial Overview The study tests if limiting high-energy-dense food variety affects body mass index (BMI) in kids during an 18-month family-based treatment (FBT). It compares standard FBT against FBT plus varied diet interventions, measuring changes in weight, eating habits, and physical activity.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: FBT+VarietyExperimental Treatment1 Intervention
The FBT+Variety condition will receive FBT along with a limited variety prescription. In this prescription families will identify two RED foods, a dinner entree and snack food, and develop meal plans that reduce variety of RED foods by regularly consuming these foods and limiting consumption of other RED entrees and snack foods.
Group II: FBT (family-based behavioral treatment)Active Control1 Intervention
This condition will be prescribed the Traffic Light Diet (1000-1500 kcal/day, \< 2 servings/day of RED \[non-nutrient-dense, energy-dense\] foods) and a \> 60 min/day of MVPA prescription for children and \> 30 min/day of MVPA for adults at least 5 days/week. FBT will receive a family-based, behavioral intervention to assist the targeted child and a participating adult caregiver with making changes in energy balance behaviors.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Tennessee, Knoxville

Lead Sponsor

Trials
93
Recruited
19,500+

The Miriam Hospital

Collaborator

Trials
252
Recruited
39,200+

University at Buffalo

Collaborator

Trials
139
Recruited
105,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

University of Memphis

Collaborator

Trials
73
Recruited
12,000+
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