Fit 24 Technology Intervention YOUTH

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04953442
• Other study ID #: H-49195
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: June 28, 2024

Study information

• Verified date: May 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 28, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Mass Index	Height and weight will be measured to the nearest 0.1cm and 0.1 kg, using a portable stadiometer and research scale to calculate BMI percentile.	4 months
Other	Psychological need fulfillment as assessed using Psychological Need Satisfaction in Exercise Scale (PNSE)	The Psychological Need Satisfaction in Exercise Scale (18-items) will be used to assess psychological needs fulfillment. The total possible scores in the PNSE are 6-108 with higher scores reflect greater perceptions of psychological need fulfillment.	4 months
Other	Autonomous motivation for physical activity as assessed using Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2)	The Behavioural Regulation in Exercise Questionnaire-2 (23-items) will be used to assess autonomous motivation for physical activity. The total possible scores on the BREQ-2 are -24 to 24, with a higher score indicating reflect more self-determined motivation whereas negative scores indicate less self-determined motivation.	4 months
Primary	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
Primary	Number of technical issues experienced by participants	We will record the number of technical issues experienced by participants throughout the study.	12-weeks
Primary	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	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
Secondary	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