Study Summary
This trial will test if a goal-setting intervention using a Fitbit and text messaging can help improve physical activity and sleep in obese Hispanic adolescents.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 2 Secondary · Reporting Duration: 4 months
12-weeks
Number of technical issues experienced by participants
Percentage of participants that are satisfied with participation in the study
4 months
Autonomous motivation for physical activity as assessed using Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2)
Average of minutes of physical activity per day
Average of minutes of sleep per night
Body Mass Index
Number participants recruited and the number of participants that complete data collection
Psychological need fulfillment as assessed using Psychological Need Satisfaction in Exercise Scale (PNSE)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Wait List Control
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment
70 Total Participants · 2 Treatment Groups
Primary Treatment: Fit 24 · No Placebo Group · N/A
Intervention
Behavioral
Experimental Group · 1 Intervention: Fit 24 · Intervention Types: BehavioralWait List ControlNoIntervention Group · 1 Intervention: Wait List Control · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
923 Previous Clinical Trials
5,987,979 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,148 Previous Clinical Trials
4,074,679 Total Patients Enrolled
Eligibility Criteria
Age 14 - 16 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Baylor College of Medicine | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "I am taking my medication regularly still my diabetes is not under control"
What questions have other patients asked about this trial?
- "what results can I expect from you study?"
How many prior treatments have patients received?
| 0 | 100.0% |
References
- 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. Review.
- 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.
- Erica Gabrielle Soltero Ngwolo 2021. "Fit 24 Technology Intervention YOUTH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04953442.
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Conditions
Cancer Related
Treatments