Fit 24 Technology Intervention YOUTH

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Fit 24

• 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
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Arm && Interventions

Group	Intervention	Description
Intervention	Fit 24	Fitbit Device Self-Determination Theory Text Messages

Primary Outcome Measures

Name	Time	Method
Number of technical issues experienced by participants	12-weeks	We will record the number of technical issues experienced by participants throughout the study.
Number participants recruited and the number of participants that complete data collection	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.
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 of minutes of physical activity per day	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	4 months	Sleep will be assessed using accelerometry to assess average minutes/night using a 24-hour, 7-day accelerometer protocol.

Trial Locations

Locations (1)

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