Fit24, a digital health intervention to reduce type 2 diabetes risk among Hispanic youth: Protocol for a feasibility pilot study

Contemp Clin Trials. 2023 Apr:127:107117. doi: 10.1016/j.cct.2023.107117. Epub 2023 Feb 10.

Abstract

Background: Poor physical activity (PA) and sleep behaviors in Hispanic adolescents contributes to increased risk for type 2 diabetes. Commonly owned digital devices and services like smartphones and text-messaging are highly used among adolescents and are promising intervention tools for reaching this age group. Personal activity trackers assess activity and sleep, making them ideal tools for addressing these behaviors. We propose to examine the feasibility of a 12-week intervention that uses theoretically grounded text messages and a Fitbit device to improve PA and sleep among Hispanic adolescents with obesity, as compared to a wait-list control group with a Fitbit device only.

Methods: Participants (N = 48; 14-16 years) will be randomized (1:1) to the intervention or wait-list control group. Youth in the intervention will receive a Fitbit Charge 5 and daily text messages. Youth in the wait-list control group will receive a Fitbit Charge 5 and information on PA and sleep guidelines.

Results: Feasibility will be examined by collecting process evaluation data on the following criteria: (1) recruit 48 Hispanic adolescents 14-16 years; (2) retain 85% of participants for post-assessments; (3) Fitbit wear ≥4 days/week and respond to 80% of text messages when prompted; (4) ≤10% technical issues; and (5) obtain 80% satisfaction from participants.

Discussion: This study will advance our knowledge on the feasibility of digital prevention strategies to promote PA and sleep behaviors to reduce T2D risk among Hispanic youth. If feasible, this approach has the potential to be a scalable, cost-effective diabetes prevention strategy among high-risk youth.

Trial registration: NCT04953442, registered on July 8, 2021.

Keywords: Adolescent health; Digital health; Health disparities; Physical activity; Sleep; Type 2 diabetes.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adolescent
  • Diabetes Mellitus, Type 2* / prevention & control
  • Exercise*
  • Feasibility Studies
  • Fitness Trackers
  • Hispanic or Latino
  • Humans
  • Mobile Applications*
  • Pilot Projects
  • Randomized Controlled Trials as Topic

Associated data

  • ClinicalTrials.gov/NCT04953442