Fit 24 Technology Intervention YOUTH
Primary Purpose
Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fit 24
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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.
Sites / Locations
- Baylor College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Wait List Control
Arm Description
Fitbit Device Self-Determination Theory Text Messages
Informational flyer of evidence-based strategies on engaging in healthy physical activity and sleep lifestyle habits.
Outcomes
Primary Outcome Measures
Number participants recruited and the number of participants that complete data collection
We will record the number participants recruited, screened, and enrolled in the study. We will also record the percentage of participants that complete data collection.
Number of technical issues experienced by participants
We will record the number of technical issues experienced by participants throughout the study.
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.
Secondary Outcome Measures
Average of minutes of physical activity per day
Physical activity will be assessed using accelerometry to assess average minutes/day using a 24-hour, 7-day accelerometer protocol.
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.
Full Information
NCT ID
NCT04953442
First Posted
June 2, 2021
Last Updated
July 31, 2023
Sponsor
Baylor College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04953442
Brief Title
Fit 24 Technology Intervention YOUTH
Official Title
Fit 24: Using Technology to Improve Activity and Sleep in Hispanic Youth
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Fitbit Device Self-Determination Theory Text Messages
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
Informational flyer of evidence-based strategies on engaging in healthy physical activity and sleep lifestyle habits.
Intervention Type
Behavioral
Intervention Name(s)
Fit 24
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number participants recruited and the number of participants that complete data collection
Description
We will record the number participants recruited, screened, and enrolled in the study. We will also record the percentage of participants that complete data collection.
Time Frame
4 months
Title
Number of technical issues experienced by participants
Description
We will record the number of technical issues experienced by participants throughout the study.
Time Frame
12-weeks
Title
Percentage of participants that are satisfied with participation in the study
Description
We will use a survey to assess the % of participants that are satisfied with participation in the study.
Time Frame
12-weeks
Secondary Outcome Measure Information:
Title
Average of minutes of physical activity per day
Description
Physical activity will be assessed using accelerometry to assess average minutes/day using a 24-hour, 7-day accelerometer protocol.
Time Frame
4 months
Title
Average of minutes of sleep per night
Description
Sleep will be assessed using accelerometry to assess average minutes/night using a 24-hour, 7-day accelerometer protocol.
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Body Mass Index
Description
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.
Time Frame
4 months
Title
Psychological need fulfillment as assessed using Psychological Need Satisfaction in Exercise Scale (PNSE)
Description
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.
Time Frame
4 months
Title
Autonomous motivation for physical activity as assessed using Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2)
Description
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.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Soltero, PhD
Phone
713-798-7154
Email
soltero@bcm.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36331547
Citation
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.
Results Reference
derived
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Fit 24 Technology Intervention YOUTH
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