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Families Becoming Healthy Together
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.
Conditions:
🦠 Obesity 🦠 Childhood Obesity
🗓️ Study Start (Actual) 29 October 2019
🗓️ Primary Completion (Estimated) 27 January 2025
✅ Study Completion (Estimated) 27 January 2025
👥 Enrollment (Estimated) 156
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Knoxville, Tennessee, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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.
Ages Eligible for Study: 8 Years to 12 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 July 2019
  • First Submitted that Met QC Criteria 16 July 2019
  • First Posted 22 July 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 August 2023
  • Last Update Posted 16 August 2023
  • Last Verified August 2023
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