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Fit 24 Technology Intervention for Type 2 Diabetes

N/A
Recruiting
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obese, defined as body mass index percentile (BMI%) ≥ 95th percentile
Ages of 14-16 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

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.

Who is the study for?
This trial is for Hispanic adolescents aged 14-16 with obesity, defined as having a BMI at or above the 95th percentile. Participants must own a cellphone and not be on medications like steroids, have conditions affecting activity/sleep/cognition, be pregnant, recently hospitalized, injured, or already using fitness trackers or in an exercise program.Check my eligibility
What is being tested?
The study tests a Fitbit device and text messaging-based goal-setting intervention aimed at increasing physical activity and improving sleep among obese Hispanic teenagers.See study design
What are the potential side effects?
Since this trial involves non-invasive technology and lifestyle changes rather than medication, side effects are minimal but may include skin irritation from wearing the Fitbit or increased fatigue due to new physical activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is in the top 5% for my age and height.
Select...
I am between 14 and 16 years old.
Select...
I am considered obese based on my BMI percentile.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of technical issues experienced by participants
Number participants recruited and the number of participants that complete data collection
Percentage of participants that are satisfied with participation in the study
Secondary outcome measures
Average of minutes of physical activity per day
Average of minutes of sleep per night
Other outcome measures
Autonomous motivation for physical activity as assessed using Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2)
Body Mass Index
Psychological need fulfillment as assessed using Psychological Need Satisfaction in Exercise Scale (PNSE)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Fitbit Device Self-Determination Theory Text Messages
Group II: Wait List ControlActive Control1 Intervention
Informational flyer of evidence-based strategies on engaging in healthy physical activity and sleep lifestyle habits.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,110 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,314,996 Total Patients Enrolled

Media Library

Fit 24 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04953442 — N/A
Type 2 Diabetes Research Study Groups: Intervention, Wait List Control
Type 2 Diabetes Clinical Trial 2023: Fit 24 Highlights & Side Effects. Trial Name: NCT04953442 — N/A
Fit 24 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04953442 — N/A
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04953442 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor offering enrollment to individuals who are 65 years and older?

"This research is recruiting participants aged between 14 and 16 years old."

Answered by AI

What criteria must one fulfill to be accepted into this research program?

"This study seeks 70 Hispanic or Latino minors between 14 and 16 with type 2 diabetes mellitus. Additionally, participants must have a BMI percentile of 95% or higher as well as their own cellular device to qualify for enrollment."

Answered by AI

How many participants are actively engaging in this research project?

"Affirmative. Clinicaltrials.gov data suggests that this trial has started recruiting patients, with an initial post date of April 15th 2021 and its most recent update occurring on July 21st 2022. 70 people need to be enrolled across a single medical centre."

Answered by AI

Is this research undertaking actively seeking participants?

"Affirmative. According to available clinicaltrials.gov resources, this medical trial is currently seeking participants and has 70 positions open at 1 research centre. The study was initially posted on April 15th 2021 and the listing was last modified on July 21st 2022."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I am taking my medication regularly still my diabetes is not under control.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

what results can I expect from you study?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Fit 24 Technology Intervention YOUTH
Erica Gabrielle Soltero Ngwolo 2021. "Fit 24 Technology Intervention YOUTH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04953442.
All > Diabetes Type 2
~17 spots leftby Apr 2025
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