Fit 24 Technology Intervention YOUTH

NCT ID: NCT04953442

Last Updated: 2025-09-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2024-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Fitbit Device Self-Determination Theory Text Messages

Group Type EXPERIMENTAL

Fit 24

Intervention Type 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.

Wait List Control

Informational flyer of evidence-based strategies on engaging in healthy physical activity and sleep lifestyle habits.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

NIH

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Erica Gabrielle Soltero Ngwolo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Soltero EG, Lopez C, Musaad SM, O'Connor TM, Thompson D. Fit24, a digital health intervention to reduce type 2 diabetes risk among Hispanic youth: Protocol for a feasibility pilot study. Contemp Clin Trials. 2023 Apr;127:107117. doi: 10.1016/j.cct.2023.107117. Epub 2023 Feb 10.

Reference Type DERIVED
PMID: 36775009 (View on PubMed)

Soltero EG, Lopez C, Hernandez E, O'Connor TM, Thompson D. Technology-Based Obesity Prevention Interventions Among Hispanic Adolescents in the United States: Scoping Review. JMIR Pediatr Parent. 2022 Nov 4;5(4):e39261. doi: 10.2196/39261.

Reference Type DERIVED
PMID: 36331547 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-49195

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

HealtheTech Lifestyle Program
NCT00146510 COMPLETED PHASE1