NCT04027426Completed
Families Becoming Healthy Together
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 166 (actual)
- First submitted
- 13 Jul 2019
- Start date
- 29 Oct 2019
- Primary completion date
- 28 Feb 2025
- Lead sponsor
- The University of Tennessee, Knoxville
- Diseases
- Obesity
- NCT number
- NCT04027426
What you commit to
- Study type: Interventional
- Participants enrolled: 166
- From 29 Oct 2019 to the primary completion date, 28 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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 major psychiatric diseases or organic brain syndromes
- child or adult caregiver report allergies to lemon or lime juice (used in habituation measures)
- 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.
Other
- child and adult caregiver report living in two separate households for \> 2 days per week
- child or adult caregiver report being unable to walk for 2 blocks (1/4 mile) without stopping
- 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 is not able to read at a third-grade reading level.
- do not have reliable internet access.
Who the study is looking for
- 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
Age in the registry: 8 years to 12 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Healthy Eating and Activity Lab, University of Tennessee Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.