Families Becoming Healthy Together

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.

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• The Miriam Hospital

  collaborator OTHER

• University of Memphis

  collaborator OTHER

• University at Buffalo

  collaborator OTHER

• The University of Tennessee, Knoxville

  lead OTHER

Principal Investigators

• Hollie Raynor, PhD RD LDN · University of Tennessee Knoxville

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-29

Primary Completion

2025-02-28

Completion

2025-02-28

Countries

• United States

Study Locations