Fit 24 Technology Intervention YOUTH

Sponsor
Baylor College of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04953442
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
70
1
2
36
1.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Fit 24
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Fit 24: Using Technology to Improve Activity and Sleep in Hispanic Youth
Actual Study Start Date :
Apr 15, 2021
Anticipated Primary Completion Date :
Apr 15, 2024
Anticipated Study Completion Date :
Apr 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Fitbit Device Self-Determination Theory Text Messages

Behavioral: Fit 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.

No Intervention: Wait List Control

Informational flyer of evidence-based strategies on engaging in healthy physical activity and sleep lifestyle habits.

Outcome Measures

Primary Outcome Measures

  1. Number participants recruited and the number of participants that complete data collection [4 months]

    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.

  2. Number of technical issues experienced by participants [12-weeks]

    We will record the number of technical issues experienced by participants throughout the study.

  3. 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 Outcome Measures

  1. Average of minutes of physical activity per day [4 months]

    Physical activity will be assessed using accelerometry to assess average minutes/day using a 24-hour, 7-day accelerometer protocol.

  2. Average of minutes of sleep per night [4 months]

    Sleep will be assessed using accelerometry to assess average minutes/night using a 24-hour, 7-day accelerometer protocol.

Other Outcome Measures

  1. Body Mass Index [4 months]

    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.

  2. Psychological need fulfillment as assessed using Psychological Need Satisfaction in Exercise Scale (PNSE) [4 months]

    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.

  3. Autonomous motivation for physical activity as assessed using Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2) [4 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 16 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baylor College of Medicine Houston Texas United States 77030

Sponsors and Collaborators

  • Baylor College of Medicine
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erica Gabrielle Soltero Ngwolo, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT04953442
Other Study ID Numbers:
  • H-49195
First Posted:
Jul 8, 2021
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2022