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COMPLETED

NCT04027426

Families Becoming Healthy Together

Sponsor: The University of Tennessee, Knoxville

View on ClinicalTrials.gov

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 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 Details

Gender

All

Age Range

8 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

166

Start Date

2019-10-29

Completion Date

2025-02-28

Last Updated

2026-10-19

Healthy Volunteers

Yes

Conditions

Obesity Childhood Obesity

Interventions

BEHAVIORAL

FBT

FBT will receive a family-based, behavioral intervention for childhood obesity, consisting of group meetings once a week for months 1 to 4, twice a month for months 5 to 6, once a month for months 7 to 12, and once every two months for months 13 to 18 (29 sessions). For all meetings, the child and adult caregiver will be weighed and be provided with feedback, homework will be reviewed, and a behavioral lesson will be presented. At the 60-min meetings, the child and adult will attend separate 40 min group meetings, and then for the last 20 min of the meetings they will meet together with an individual therapist to address specific family-issues by developing behavioral action plans. No goals on variety in RED foods will be provided.

BEHAVIORAL

FBT+Variety

This condition is FBT with a limited variety prescription. The limited variety prescription reduces the number of different RED foods consumed.

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.

Locations (1)

Healthy Eating and Activity Lab, University of Tennessee

Knoxville, Tennessee, United States