Fit 24 Technology Intervention YOUTH

April 13, 2026 updated by: Erica Gabrielle Soltero Ngwolo, Baylor College of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number Participants Recruited
Time Frame: 4 months
We will record the number participants recruited, screened, and enrolled in the study.
4 months
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.
12-weeks
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.
12-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Minutes of Physical Activity
Time Frame: Baseline and 12-weeks post intervention
Physical activity was measured using accelerometry for a 7 day protocol.
Baseline and 12-weeks post intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index
Time Frame: 4 months
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
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.
4 months
Psychological Need Fulfillment as Assessed Using Psychological Need Satisfaction in Exercise Scale (PNSE)
Time Frame: 4 months
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
Autonomous Motivation for Physical Activity as Assessed Using Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2)
Time Frame: 4 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Actual)

March 29, 2024

Study Completion (Actual)

April 28, 2024

Study Registration Dates

First Submitted

June 2, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-49195

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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