Fit 24 Technology Intervention YOUTH

NCT04953442 | Completed Results DMC

• 1 other identifier: H-49195
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Number Participants Recruited

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

  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 Outcomes (1)

• Average Minutes of Physical Activity

  Baseline and 12-weeks post intervention

Other Outcomes (4)

• Average of Minutes of Sleep Per Night

  4 months

• Body Mass Index

  4 months

• Psychological Need Fulfillment as Assessed Using Psychological Need Satisfaction in Exercise Scale (PNSE)

  4 months

Study Arms (2)

Intervention

EXPERIMENTAL

Fitbit Device Self-Determination Theory Text Messages

Behavioral: Fit 24

Wait List Control

NO INTERVENTION

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

Interventions

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.

Intervention

Eligibility Criteria

• Age: 14 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 36775009 DERIVED

• 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.

  PMID: 36331547 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Limitations included issues related to the feasibility of the Fitbit device. Several participants reported that the Fitbit watch band was uncomfortable and irritated their skin. The Fitbit device syncs through the Fitbit app once a Bluetooth connection has been established; however, sync issues occurred in this study due to a loss of Bluetooth connection, differences in app settings, or differences in operating systems that did not allow for the automatic or continuous syncing of the device.

Results Point of Contact

• Title: Erica Soltero, PhD
• Organization: Baylor College of Medicine

soltero@bcm.edu

4029100832

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: July 8, 2021
• Study Start: April 15, 2021
• Primary Completion: March 29, 2024
• Study Completion: April 28, 2024
• Last Updated: May 4, 2026
• Results First Posted: September 15, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)