Fit 24 Technology Intervention YOUTH

Overview

The purpose of this study is to examine the effects of a goal-setting intervention that utilizes a Fitbit device and text messaging to improve physical activity and sleep in Hispanic adolescents with obesity.

Full Title of Study: “Fit 24: Using Technology to Improve Activity and Sleep in Hispanic Youth”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 15, 2024

Detailed Description

Hispanic adolescents are disproportionately burdened by obesity and type 2 diabetes compared to non-Hispanic white youth. Disparities in T2D emerge early in life and are driven in part by unhealthy lifestyle behaviors including low levels of physical activity, excessive time spent in sedentary behaviors and short sleep durations. Given that Hispanic youth are the fastest growing pediatric subgroup in the U.S., developing strategies to promote healthy lifestyle behaviors and addressing T2D disparities is a public health imperative. Wearable activity monitoring devices like Fitbits are designed to continuously monitor both wake time and sleep behaviors. Therefore the purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a 12-week technology-based intervention that uses a Fitbit and text messages grounded in the Self-Determination Theory to promote healthy lifestyle habits and reduce risk for type 2 diabetes among a Hispanic adolescents with obesity.

Interventions

  • Behavioral: Fit 24
    • This 12-week goal-setting intervention will test the feasibility of using a Fitbit watch and motivational text messaging to improve physical activity and sleep in Hispanic youth (14-16 years of age) with obesity. Youth will be prompted to set weekly steps per day and hours of sleep per night goals. Text messages will be grounded in the Self-Determination Theory and will provide evidence-based strategies, support, and motivation to encourage youth to meet their goals.

Arms, Groups and Cohorts

  • Experimental: Intervention
    • Fitbit Device Self-Determination Theory Text Messages
  • No Intervention: Wait List Control
    • Informational flyer of evidence-based strategies on engaging in healthy physical activity and sleep lifestyle habits.

Clinical Trial Outcome Measures

Primary Measures

  • Number participants recruited and the number of participants that complete data collection
    • Time Frame: 4 months
    • We will record the number participants recruited, screened, and enrolled in the study. We will also record the percentage of participants that complete data collection.
  • Number of technical issues experienced by participants
    • Time Frame: 12-weeks
    • We will record the number of technical issues experienced by participants throughout the study.
  • Percentage of participants that are satisfied with participation in the study
    • Time Frame: 12-weeks
    • We will use a survey to assess the % of participants that are satisfied with participation in the study.

Secondary Measures

  • Average of minutes of physical activity per day
    • Time Frame: 4 months
    • Physical activity will be assessed using accelerometry to assess average minutes/day using a 24-hour, 7-day accelerometer protocol.
  • Average of minutes of sleep per night
    • Time Frame: 4 months
    • Sleep will be assessed using accelerometry to assess average minutes/night using a 24-hour, 7-day accelerometer protocol.

Participating in This Clinical Trial

Inclusion Criteria

  • Self identify as Hispanic or Latino – obese, defined as body mass index percentile (BMI%) ≥ 95th percentile – Ages of 14-16 years – Own his or her own cellphone. Exclusion Criteria:

  • Taking a medication(Steroids) or diagnosed with a condition (i.e. sleep (i.e. sleep apnea) that influences activity, sleep, and/or cognition – Recent hospitalization or injury that prevents normal physical activity – pregnant – currently enrolled in an exercise program or currently using a personal activity monitoring device like Fitbit.

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Baylor College of Medicine
  • Collaborator
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Erica Gabrielle Soltero Ngwolo, Assistant Professor – Baylor College of Medicine

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.