Fit 24 Technology Intervention YOUTH

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fit 24: Using Technology to Improve Activity and Sleep in Hispanic Youth

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Fit 24


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Fitbit Device Self-Determination Theory Text Messages | Behavioral: Fit 24<br>* 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.<br>|
| No Intervention: Wait List Control<br>Informational flyer of evidence-based strategies on engaging in healthy physical activity and sleep lifestyle habits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number participants recruited and the number of participants that complete data collection | 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. | 4 months | 
| Number of technical issues experienced by participants | We will record the number of technical issues experienced by participants throughout the study. | 12-weeks | 
| Percentage of participants that are satisfied with participation in the study | We will use a survey to assess the % of participants that are satisfied with participation in the study. | 12-weeks | 

Secondary Outcome Measures

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