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Completed

NCT Number: NCT04953442

Fit 24 Technology Intervention 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fit 24

Behavioral

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.

Primary outcomes

  1. Number Participants Recruited

    Time frame: 4 months

    We will record the number participants recruited, screened, and enrolled in the study.

  2. 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.

  3. 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.

Secondary outcomes

  1. Average Minutes of Physical Activity

    Time frame: Baseline and 12-weeks post intervention

    Physical activity was measured using accelerometry for a 7 day protocol.

Other outcomes

  1. 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.

  2. 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.

  3. 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. 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.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2021
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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