Families Becoming Healthy Together
Completed · Not applicable
Conditions studied: Obesity, Childhood Obesity
In brief
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.
Key facts
- Study ID
- NCT04027426
- Run by
- The University of Tennessee, Knoxville
- People needed
- 83
- Starts
- 2019-10-29
- Expected to finish
- 2025-02-28
- Last updated by the study team
- 2025-06-03
Who can join
Age: 8 and older, up to 12. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- age between 8 and 12 years
- > 85th percentile BMI
- one adult caregiver (> 18 years) living in the household with a BMI > 25 kg/m2 willing to attend treatment meetings
You may not qualify if…
- child and adult caregiver report living in two separate households for > 2 days per week
- child or adult caregiver report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) (individuals reporting joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate)
- child or adult caregiver report being unable to walk for 2 blocks (1/4 mile) without stopping
- child or adult caregiver report major psychiatric diseases or organic brain syndromes
- child or adult caregiver report currently participating in a weight loss program and/or taking weight loss or appetite regulation medication or lost > 5% of body weight during the past 6 months
- child report having bariatric surgery for weight loss/planning to have bariatric surgery in the next 18 months, adult caregiver having bariatric surgery in the previous two years or planning to have bariatric surgery in the next 18 months
- adult caregiver reports being pregnant, lactating, less than 6 months post-partum or plans to become pregnant in the next 18 months
- child or adult caregiver report planning to move outside of the metropolitan area (defined as from Nashville to the east state border of Tennessee) or Memphis (this may include residents who live in Arkansas or Mississippt) within the time frame of the investigation
- child or adult caregiver report dietary restrictions for medical reasons
- 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.
- do not have reliable internet access.
- participation in the study creates conflict with child's educational support or health condition treatment/program due to time needs, incompatible goals, or strain on family resources.
Where it is running
- Healthy Eating and Activity Lab, University of Tennessee — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
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