Fit 24 Technology Intervention YOUTH

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT04953442
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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.

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.

Study Timeline

• Study Start: 2021-04-15
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-08
• Primary Completion: 2024-03-29
• Study Completion: 2024-04-28
• Results First Submitted: 2025-07-22
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Results First Posted: 2025-09-15
• Last Update Posted: 2025-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number Participants Recruited	4 months	We will record the number participants recruited, screened, and enrolled in the study.
Number of Technical Issues Experienced by Participants	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	12-weeks	We will use a survey to assess the % of participants that are satisfied with participation in the study.

Secondary Outcome Measures

Name	Time	Method
Average Minutes of Physical Activity	Baseline and 12-weeks post intervention	Physical activity was measured using accelerometry for a 7 day protocol.

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States