Design of the FRESH-DOSE study: A randomized controlled noninferiority trial evaluating a guided self-help

Kerri N Boutelle1, Kyung E Rhee2, Michael A Manzano3

  • 1Department of Pediatrics, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA; Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA.

Insights

A new guided self-help version of Family-Based Behavioral Treatment (gshFBT) offers a promising, accessible approach to childhood obesity management. This intervention could significantly improve reach for effective weight management strategies in children.

Area of Science:

  • Pediatric Endocrinology
  • Public Health
  • Behavioral Science

Background:

  • Childhood obesity affects 45% of children, increasing risks for negative health outcomes.
  • Family-Based Behavioral Treatment (FBT) is effective but resource-intensive.
  • Guided Self-Help (GSH) therapies offer a scalable alternative by combining manuals with coaching.

Purpose of the Study:

  • To evaluate the efficacy and cost-effectiveness of a novel Guided Self-Help version of Family-Based Behavioral Treatment (gshFBT) for pediatric weight management.
  • To compare gshFBT with traditional group-based FBT in a randomized controlled trial.
  • To assess long-term outcomes of gshFBT for child weight change (BMIz).

Main Methods:

  • A randomized controlled trial involving 150 children (mean age 10.1 years, mean BMI% 97.3%) and one parent.
  • Participants were assigned to either group-based FBT or gshFBT (manual + 14 coaching sessions over 6 months).
  • Assessments included baseline, post-treatment (6 months), and follow-ups at 12 and 18 months, focusing on child BMIz and cost-effectiveness.

Main Results:

  • Recruitment completed between May 2017 and October 2021.
  • Follow-up assessments are ongoing, with primary outcomes being child weight change (BMIz) and cost-effectiveness.
  • The study is poised to provide crucial data on gshFBT's effectiveness and accessibility.

Conclusions:

  • gshFBT presents a potentially scalable and accessible intervention for childhood obesity.
  • This approach may overcome barriers associated with traditional, resource-intensive FBT programs.
  • gshFBT could significantly expand access to effective pediatric weight management interventions.

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