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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Fitbit Device Self-Determination Theory Text Messages |
|
| Wait List Control | No Intervention | Informational flyer of evidence-based strategies on engaging in healthy physical activity and sleep lifestyle habits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Minutes of Physical Activity | Physical activity was measured using accelerometry for a 7 day protocol. | Baseline and 12-weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36775009 | Derived | 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. | |
| 36331547 | 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. |
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After baeline data collection participating youth were randomized (1:1 randomization) to the intervention or to a waitlist control group. The youth in the intervention received a Fitbit Charge 5 device and daily SMS text messages grounded in SDT. Youth randomized to the waitlist control group received a Fitbit Charge 5 device and a one-page informational handout on PA and sleep guidelines.
Youth were recruited from local pediatric clinics, community-based organizations (eg, Houston Public Library and Baker Ripley Community Developers), and by word of mouth. Interested participants were screened via telephone for eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Wait List Control | Youth randomized to the waitlist control group received a Fitbit Charge 5 device and a one-page informational handout on PA and sleep guidelines. |
| FG001 | Intervention | The youth in the intervention received a Fitbit Charge 5 device and daily SMS text messages grounded in SDT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Fitbit Device Self-Determination Theory Text Messages |
| BG001 | Wait List Control | Informational flyer of evidence-based strategies on engaging in healthy physical activity and sleep lifestyle habits. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was self-reported. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number Participants Recruited | We will record the number participants recruited, screened, and enrolled in the study. | This is the count of participants that were enrolled in each intervention arm. | Posted | Count of Participants | Participants | 4 months |
|
From enrollment up to 14 weeks
Given that no adverse events were experienced, there is no relevant information about adverse event collection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Fitbit Device Self-Determination Theory Text Messages | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erica Soltero, PhD | Baylor College of Medicine | 4029100832 | soltero@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2020 | Jul 22, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2020 | Sep 12, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 4 months |
| 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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex was self-reported as sex assigned at birth. | Sex was self-reported as sex assigned at birth. | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Self Reported demographic survey completed by parents | Self Reported demographic survey completed by parents | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Technical Issues Experienced by Participants | We will record the number of technical issues experienced by participants throughout the study. | Posted | Number | number of technical issues | 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. | Only participants originally randomized to the intervention completed the exit survey to indicate their satisfaction with the intervention. | Posted | Count of Participants | Participants | 12-weeks |
|
|
|
| Secondary | Average Minutes of Physical Activity | Physical activity was measured using accelerometry for a 7 day protocol. | Not Posted | Apr 2026 | Baseline and 12-weeks post intervention | Participants |
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | minutes/night | 4 months |
|
|
|
| Other Pre-specified | 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. | Not Posted | May 2026 | 4 months | Participants |
| Other Pre-specified | 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. | Not Posted | May 2026 | 4 months | Participants |
| Other Pre-specified | 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. | Not Posted | May 2026 | 4 months | Participants |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Wait List Control | Informational flyer of evidence-based strategies on engaging in healthy physical activity and sleep lifestyle habits. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D004700 | Endocrine System Diseases |