Diabetes Mellitus, Type 2
Conditions
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.
Interventions
BEHAVIORALFit 24
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.
Sponsors
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 16 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Participants Recruited | 4 months | We will record the number participants recruited, screened, and enrolled in the study. |
| Number of Technical Issues Experienced by Participants | 12-weeks | 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 | 12-weeks | We will use a survey to assess the % of participants that are satisfied with participation in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Minutes of Physical Activity | Baseline and 12-weeks post intervention | Physical activity was measured using accelerometry for a 7 day protocol. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Fitbit Device Self-Determination Theory Text Messages | 22 |
| Wait List Control Informational flyer of evidence-based strategies on engaging in healthy physical activity and sleep lifestyle habits. | 21 |
| Total | 43 |
Baseline characteristics
| Characteristic | Intervention | Wait List Control | Total |
|---|---|---|---|
| Age, Continuous | 15.09 years STANDARD_DEVIATION 0.768 | 14.95 years STANDARD_DEVIATION 0.95 | 15.02 years STANDARD_DEVIATION 0.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 21 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 21 |
| other Total, other adverse events | 0 / 22 | 0 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 |
Outcome results
Primary
Number of Technical Issues Experienced by Participants
We will record the number of technical issues experienced by participants throughout the study.
Time frame: 12-weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wait List Control | Number of Technical Issues Experienced by Participants | 0 number of technical issues |
| Intervention | Number of Technical Issues Experienced by Participants | 16 number of technical issues |
Primary
Number Participants Recruited
We will record the number participants recruited, screened, and enrolled in the study.
Time frame: 4 months
Population: This is the count of participants that were enrolled in each intervention arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wait List Control | Number Participants Recruited | 21 Participants |
| Intervention | Number Participants Recruited | 22 Participants |
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.
Time frame: 12-weeks
Population: Only participants originally randomized to the intervention completed the exit survey to indicate their satisfaction with the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wait List Control | Percentage of Participants That Are Satisfied With Participation in the Study | 0 Participants |
| Intervention | Percentage of Participants That Are Satisfied With Participation in the Study | 19 Participants |
Secondary
Average Minutes of Physical Activity
Physical activity was measured using accelerometry for a 7 day protocol.
Time frame: Baseline and 12-weeks post intervention
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.
Time frame: 4 months
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.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wait List Control | Average of Minutes of Sleep Per Night | 503.3 minutes/night | Standard Deviation 87.7 |
| Intervention | Average of Minutes of Sleep Per Night | 470.98 minutes/night | Standard Deviation 60.54 |
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.
Time frame: 4 months
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.
Time frame: 4 months