Clinical trial NCT04953442: Fit 24 Technology Intervention YOUTH
Official title: Fit 24: Using Technology to Improve Activity and Sleep in Hispanic Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-07-08
Enrollment: 63
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number participants recruited and the number of participants that complete data collection
timeFrame: 4 months
measure: Number of technical issues experienced by participants
timeFrame: 12-weeks
measure: Percentage of participants that are satisfied with participation in the study
timeFrame: 12-weeks
Secondary outcomes:
measure: Average of minutes of physical activity per day
timeFrame: 4 months
measure: Average of minutes of sleep per night
timeFrame: 4 months
Other outcomes:
measure: Body Mass Index
timeFrame: 4 months
measure: Psychological need fulfillment as assessed using Psychological Need Satisfaction in Exercise Scale (PNSE)
timeFrame: 4 months
measure: Autonomous motivation for physical activity as assessed using Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2)
timeFrame: 4 months
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
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.