Status:
COMPLETED
Families Becoming Healthy Together
Lead Sponsor:
The University of Tennessee, Knoxville
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Miriam Hospital
Conditions:
Obesity
Childhood Obesity
Eligibility:
All Genders
8-12 years
Phase:
NA
Brief Summary
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 fi...
Detailed Description
Identifying successful methods for reducing long-term energy intake continues to be a challenge in obesity treatment. Basic behavioral research has found that the rate of habituation (i.e., rate of re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT04027426
Start Date
October 29 2019
End Date
February 28 2025
Last Update
June 3 2025
Active Locations (1)
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1
Healthy Eating and Activity Lab, University of Tennessee
Knoxville, Tennessee, United States, 37996