Fit 24: Using Technology to Improve Activity and Sleep in Hispanic Youth
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sponsor: Baylor College of Medicine

 
 
Institutional Review Board for Baylor College of Medicine and Affiliated
Hospitals
 
Protocol Number:    H-49195
Status:                        Approved
Initial Submit Date:  12/14/2020
Approval Period:       4/1/2021 - 1/5/2026
 
Section Aa:  Title & PI
A1.  Main Title
     FIT24: USING TECHNOLOGY TO IMPROVE ACTIVITY AND SLEEP IN HISPANIC YOUTH
A2.  Principal Investigator
 
     Name:  
ERICA SOLTERO NGWOLO
Phone:  
7137987154
     Id:  
208468
Fax:  
     Department:  PEDIATRICS: NUTRITION
Email:   
soltero@bcm.edu
     Center:  
Mail Stn:  BCM320
A3.  Administrative Contact
     None
A3a.  Financial Conflict of Interest
Does any member of study personnel (Investigator (including investigator's spouse and/or dependent children)) that are
involved in the design, conduct, or reporting of the research have a Significant Financial Interest (SFI) that would reasonably
appear to be affected by the research for which funding is sought and/or associated with an entity/business that would
reasonably appear to be affected by the research?
          No
 
Section Ab:  General Information    
A4.  Co-Investigators
 
     Name:  
TERESIA O'CONNOR
Phone:  
7137986782
Id:  
128465
Fax:  
7137987098
Department:  PEDIATRICS: NUTRITION
Email:   
teresiao@bcm.edu
Center:  
Mail Stn:  BCM320
 
     Name:  
DEBORAH THOMPSON
Phone:  
7137987076
Id:  
133410
Fax:  
713 7987098
Department:  PEDIATRICS: NUTRITION
Email:   
dit@bcm.edu
Center:  
Mail Stn:  BCM320
 
     Name:  
SALMA MUSAAD
Phone:  
7137987058
Id:  
207944
Fax:  
Department:  PEDIATRICS: NUTRITION
Email:   
musaad@bcm.edu
Center:  
Mail Stn:  BCM320
 
     Name:  
AYLEEN HERNANDEZ
Phone:  
Id:  
234956
Fax:  
Department:  STUDENT AFFAIRS
Email:   
u234956@bcm.edu
Center:  
Mail Stn:  
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     Name:  
SANDRA MIHAIL
Phone:  
Id:  
235036
Fax:  
Department:  STUDENT AFFAIRS
Email:   
u235036@bcm.edu
Center:  
Mail Stn:  
 
     Name:  
ANNA HSU
Phone:  
7137987154
Id:  
244453
Fax:  
Department:  PEDIATRICS: NUTRITION
Email:   
u244453@bcm.edu
Center:  
Mail Stn:  BCM320
 
     Name:  
DEBORAH BABALOLA
Phone:  
Id:  
244720
Fax:  
Department:  STUDENT AFFAIRS
Email:   
u244720@bcm.edu
Center:  
Mail Stn:  
 
     Name:  
LIZETTE VILLANUEVA
Phone:  
Id:  
247316
Fax:  
Department:  PEDIATRICS: NUTRITION
Email:   
u247316@bcm.edu
Center:  
Mail Stn:  
 
     Name:  
MIGUEL CAMEJO FERNANDEZ
Phone:  
7137987154
Id:  
247445
Fax:  
Department:  PEDIATRICS: NUTRITION
Email:   
u247445@bcm.edu
Center:  
Mail Stn:  BCM320
 
     Name:  
ALEXIS RENDON
Phone:  
Id:  
251749
Fax:  
Department:  GRADUATE SCHOOL OF BIOMEDICAL SCIENCES
Email:   
u251749@bcm.edu
Center:  
Mail Stn:  
 
     Name:  
KARINA LOPEZ
Phone:  
Id:  
Non-Baylor
Fax:  
Institution:  
Baylor College of Medecine
Email:   
karina.lopez@uth.tmc.edu
Address:  
 
     Name:  
MARBELLY PARTIDA
Phone:  
Id:  
Non-Baylor
Fax:  
Institution:  
Texas A&M University
Email:   
marbelly.03-
02_1999@tamu.edu
Address:  
 
     Name:  
OSAMAH SALIM
Phone:  
(713) 306-5575
Id:  
Non-Baylor
Fax:  
Institution:  
University of Texas
Email:   
osalim@utexas.edu
Address:  
2405 Robert Dedman Dr, Austin, TX 78712
 
     Name:  
ZABRINA SIDHU
Phone:  
Id:  
Non-Baylor
Fax:  
Institution:  
Rice University
Email:   
zks1@rice.edu
Address:  
6100 Main Street, Houston, TX, 77005
 
     Name:  
NATASHA FLORES-ACTON
Phone:  
Id:  
Non-Baylor
Fax:  
Institution:  
Rice University
Email:   
nf17@rice.edu
Address:  
6100 Main Street, Houston, TX 77005
 
     Name:  
EMILY NGUYEN
Phone:  
Id:  
Non-Baylor
Fax:  
Institution:  
University of Houston
Email:   
emily172021@gmail.com
Address:  
4211 Elgin Street, Suite 200 Houston, Texas 77204-1011
 
     Name:  
ANA RIVERA
Phone:  
Id:  
Non-Baylor
Fax:  
Institution:  
Rice University
Email:   
asr12@rice.edu
Address:  
 
     Name:  
JASON MENDOZA
Phone:  
206-744-9500
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Id:  
Non-Baylor
Fax:  
Institution:  
University of Washington
Email:   
jason.mendoza@seattlechildrens.org
Address:  
325 9th Ave Seattle, WA 98104-2499
 
     Name:  
DEBORAH PARRA-MEDINA
Phone:  
(512) 475-9315
Id:  
Non-Baylor
Fax:  
Institution:  
The University of Texas at Austin
Email:   
parramedina@austin.utexas.edu
Address:  
The University of Texas at Austin 116 Inner Campus Dr Stop
G6000 Austin, TX 78712
A5.  Funding Source:
     Organization:  NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK)
A6a.  Institution(s) where work will be performed:
     BCM: Baylor College of Medicine
HCHD: Harris County Hospital District
A6b.  Research conducted outside of the United States:
     
Country:  
Facility/Institution:  
Contact/Investigator:  
Phone Number:  
If documentation of assurances has not been sent to the Office of Research, please explain:
A7.  Research Category:
     
A8. Therapeutic Intent
Does this trial have therapeutic intent?
     No
 
A9. ClinicalTrials.gov Registration
Does this protocol/trial require registration on ClinicalTrials.gov due to it: meeting the definition of an Applicable Clinical Trial,
being required under the terms and conditions of an award, or being proposed to be published in ICMJE journals?
     Yes
 
Who will be responsible for registering and maintaining the registration of this Applicable Clinical Trial?
     The BCM PI will register the trial because either:
     -   the trial is BCM PI-initiated,
     -   BCM is the lead site of this multicenter trial, or,
     -   the industry sponsor has instructed the BCM PI to register the trial, or,
     -   registration of this trail is required as a term and condition of the reward by the funding agency.
 
ClinicalTrials.gov Identifier:
     NCT04953442
 
Section B:  Exempt Request
B.  Exempt From IRB Review
     Not Applicable
 
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Section C:  Background Information
     
Hispanic adolescents are disproportionately burdened by obesity (25.8% vs 18.5% general population) and type 2 diabetes
(T2D) 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 (PA), excessive time spent in sedentary behaviors (SB), 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. Studies
using wearable devices in conjunction with text-messaging or smartphone applications have been effective in increasing
PA in adults; however, less is known about the use of these technology-based tools among adolescents, particularly among
high-risk youth like Hispanic adolescents. Therefore the purpose of this study is to examine the feasibility, acceptability, and
preliminary efficacy of a 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 sample of Hispanic
adolescents (14-16 years) with obesity.
 
Section D:  Purpose and Objectives
     
The purpose of this study is to examine the feasibility of a 12-week goal-setting intervention that utilizes a Fitbit device and
text messages grounded in the Self-Determination Theory (SDT) to promote healthy wake time (PA,SB) and sleep
behaviors in Hispanic adolescents (14-16 years old) with obesity (BMI%≥95th).
 
Section E:  Protocol Risks/Subjects
E1.  Risk Category
     Category 1: Research not involving greater than minimum risk.
E2.  Subjects
Gender:
     Both
Age:
     Adolescent (13-17 yrs)
Ethnicity:
     Hispanic Or Latino
Primary Language:
     English, Spanish
Groups to be recruited will include:
     Healthy, non-patient, normals
Which if any of the following vulnerable populations will be recruited as subjects?
     Children
Vulnerable populations require special protections.  How will you obtain informed consent, protect subject confidentiality, and
prevent undue coercion?
     
Informed consent will be obtained from parents of participating adolescents and child assent will be obtained from
participating adolescents. Consent and assent will be obtained electronically by a trained research staff member. In this
study, qualitative interviews will be conducted remotely, thus an electronic consent/assent will be sent to the participant via
REDCap, we will schedule a time and day to speak to the participant and his/her parent or legal guardian, at which time we
will review the forms over the phone and answer any questions, and then the participant and his/her parent or legal
guardian will electronically sign the consent form and send it back to the research team. For participation in the
intervention, the participant and his/her legal guardian will complete the electronic consent/assent form in person. The
research staff member will explain all aspects of the study and answer any questions. Whether the participant is
completing the consent/assent forms remotely or in person, we will ask comprehension questions to ensure that parents
and adolescents understand all study procedures, risks, benefits, and the voluntary nature of this study. We will also
provide all participants and parents or legal guardians with a paper copy of the consent and assent forms for their personal
records.
E3.  Pregnant woman/fetus
Will pregnant women and/or fetuses (as described in 45 CFR 46 Subpart B) be enrolled in the research?
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     No
E4.  Neonates
Will neonates of uncertain viability or nonviable neonates (as described in 45 CFR 46 Subpart B) be enrolled in the research?
     No
E5.  Children
Will children be enrolled in the research?
     Yes
 
Section F:  Design/Procedure
F1.  Design
Select one category that most adequately describes your research:
     c) Pilot
Discuss the research design including but not limited to such issues as: probability of group assignment, potential for subject
to be randomized to placebo group, use of control subjects, etc.
     
In collaboration with Hispanic youth (N=30) and an expert panel (N=6), text message content will be adapted and refined
from a previously conducted pilot study. A mixed-methods approach (surveys and interviews) will be applied to ensure that
text message content adheres to the SDT and is age and culturally appropriate. A different sample of Hispanic youth
(N=48) will be recruited and randomized to the intervention or a wait-list control group. In the intervention, the youth will
receive guidance from the research team on setting weekly steps/day and hours of sleep/night goals, a Fitbit device to self-
monitor progress towards goals, and theory-informed text messages that promote autonomous motivation for behavior
change. At the end of the initial 12-week intervention, youth in the wait-list control group will be invited to participate in the
intervention. Feasibility will be evaluated using a priori criteria for recruitment, data collection, intervention implementation,
and acceptability.
This study will receive assistance from a non-BCM personnel, Marbelly Partida, will assist with the development of project
materials, assist with data collection and the implementation of the intervention. Ms. Partida will also assist in conducting
literature reviews and assisting in the lab in basic scholarly work such as creating data tables. Ms. Partida will rely on the
BCM IRB for her involvement in this research.
Inclusion Criteria:
     Participants will be screened using the following inclusion criteria: 1) Self-report as Hispanic 2) obese, defined as body
mass index percentile (BMI%) ≥ 95th percentile 3)between the ages of 14-16 years, and 4) own his or her own cellphone.
Exclusion Criteria:
     
Youth will be excluded based on the following criteria: 1) Taking a medication (i.e. steroids) or diagnosed with a condition
(i.e. sleep apnea) that influences activity, sleep, and/or cognition, 2)recent hospitalization or injury that prevents normal
physical activity, 3) pregnant, and 4) currently enrolled in an exercise program or currently using a personal activity
monitoring device like Fitbit.
F2.  Procedure
     Hispanic adolescents (N=30) will participate in in-depth interviews. Trained interviewers will use an interview script to elicit
information on:1) personal values, 2) given that social frameworks have demonstrated that multiple levels of influence
affect health behaviors in high-risk, minority youth we will ask questions as to how to promote wake-time and sleep
behaviors in a manner that is feasible and realistic in the environmental and sociocultural context of Hispanic youth, 3) the
type of goal-setting guidance and feedback desired, and 4) desired frequency and timing of text messages. To protect staff
and participants, we will conduct interviews via zoom until it is safe to host interviews in person. In-depth interviews will be
audio-recorded, transcribed, coded by two trained, independent coders, and qualitatively analyzed using NVivo version 9.
Thematic content analysis will be used to identify emergent themes to adapt existing text messages. As youth are
screened and participate in interviews, parents will complete a text-based survey, to assess their perceptions of the
intervention.
An expert panel (N=6) of co-investigators (Soltero, Thompson, Musaad, O'Connor) and consultants (Jason Mendoza,
Deborah Parra-Medina) will convene to ensure text messages are age and culturally-appropriate, adhere to the self-
determination theory, and use evidence-based strategies to promote healthy behaviors. Consultants will not participate in
any data collection or seek IRB Approval from their home institutions. Youth that participated in the interviews will review a
revised draft of the text messages and provide feedback via a survey. If extensive modifications are needed an additional
review by youth and the expert panel will be conducted.
To test the feasibility and acceptability of the intervention, we will recruit a new sample of Hispanic adolescents (14-16
years) with obesity. Youth will be randomized (1:1) to the intervention or wait-list control .
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Intervention In the intervention, youth will be given a Fitbit which has shown high validity and reliability (ICC 0.71 - 1.00) for
assessing steps/day and sleep in youth. Participants will download the Fitbit app and staff will input individual user height
and weight to improve measurement accuracy. The theory-informed text messages that were previously developed with
youth and the expert panel will be sent 3-5 times/week using a text-message platform called Mosio, which is HIPAA
compliant and secure. We have exacted a Business Associate Agreement with Mosio. At the start of the week, texts will
guide participants to set one activity and one sleep goal. Texts will promote autonomy by encouraging youth to develop
their own solutions for achieving their goals. Mid-week texts will emphasize competence, acknowledge progression
towards goals, and provide tips and evidence-based strategies for increasing health behaviors (competence). Tips and
strategies for increasing physical activity will include suggestions on resources within each participant's neighborhood,
which will require the use of their home address. End-of-week texts will provide feedback on goal achievement and
encourage participants to connect goal achievement to personal values to build relatedness.
Youth in the intervention will also receive assistance in goal-setting as well as need supportive feedback on goal
attainment. At the start of week 2, research staff will contact participants via text message to guide them in setting goals for
steps/day and hours of sleep/night based on their weekly averages from the previous week. In successive weeks,
participants will be guided to gradually increase their step count and sleep goals to meet or maintain current
recommendations of ~12,000 steps/day and 8-10 hours of sleep/night. Participants with less than 5,000 steps/day will be
guided to increase their average by 600 steps/day each week, participants with 5,000-11,999 steps/day will be guided to
increase their steps/day goal by 10% of their week 1 average in successive weeks, and participants with greater or equal
to12,000 steps/day or greater will be instructed to maintain that level of step counts in successive weeks. Achieving greater
or equal to 12,000 steps/day is equivalent to meeting PA recommendations of 60 minutes of PA/day. For sleep, participants
that average less than 8 hours of sleep/night will be encouraged to increase their average sleep time by 30 minutes each
week and participants with more than 8 hours of sleep/night will be encouraged to maintain that sleep duration. Data
collected using the Fitbit Flex is continuously collected and wirelessly transmitted to a web-based platform called Fitabase.
This secure, platform aggregates and analyzes step and sleep data at the daily, weekly, and monthly level, and provides
customized data reports for each participant. These reports will be downloaded and saved for data checks and goal
monitoring. These reports will inform help us develop texts that guide goal-setting and provide feedback on goal
achievement.
At the completion of the intervention, youth will return the Fitbit Flex to the study team.
Wait-list Control Group Youth in the wait-list control group will also receive a Fitbit and a one-page handout with standard
health information on the importance of PA and sleep to their health. After the 12-week intervention period, youth in the
wait-list control group will be invited to participate in the intervention.
Assessments Primary Outcomes: Feasibility will be evaluated using a priori criteria: recruitment, data collection, the
integrity of the study protocol, technical issues, internal consistency of measures, and satisfaction. Given this study's high
potential for dissemination in clinical settings, 'Recruitment' and 'Data Collection' criteria will assess the feasibility of
recruiting and retaining participants from community clinics. 'Integrity of Study Protocol' criteria will be used to identify the
feasible and acceptable `dose' of the intervention. `Technical Issues' criteria will assess the feasibility of using the Fitbit
device and text messaging as behavior change tools. `Internal Consistency of Measures' criteria will assess the
appropriateness of our instruments for Hispanic youth. `Satisfaction' will assess acceptability, which is especially important
for interventions in minority populations. This will provide information on the availability of high-risk youth in community
clinics and the ability of our recruitment strategies to engage youth from these settings.
Secondary outcomes: Physical activity, sedentary behaviors, and sleep will be assessed using a hip-worn wGT3X-BT
accelerometer (Actigraph, Pensacola, Florida). Participants will wear the accelerometer 24 hours a day for 7 days at both
timepoints. A research team member will review instructions for device wear and will send daily text messages to remind
participants to wear the device to promote compliance. Accelerometer data will be processed using ActiLife v6.13 software.
A valid day of wear will be defined as ≥ 18 hours of wear on 4 days or more, one of which has to be a weekend day.
Evenson cut points will be used to analyze and categorize SB (defined as <100 counts per minute) and moderate-to-
vigorous PA. The Sadeh algorithm will be used to assess sleep duration. While wrist-worn devices are superior for
assessing all sleep characteristics (i.e.sleep efficiency, wake after sleep onset, etc), hip-worn devices provide accurate
measures of sleep duration and timing. Participants will be asked to complete a wear log to indicate wake and sleep times,
which will be used to verify accelerometer data. Data will be reported as average minutes per day spent in PA, SB, and
sleep.
Tertiary Outcomes: 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. We will assess waist circumference to measure central adiposity. Psychological
Needs will be assessed using the Psychological Need Satisfaction in Exercise Scale (18-items), which has shown
acceptable validity and reliability among youth. Autonomous motivation for PA will be assessed using a scale from the
Behavioral Regulation in Exercise Questionnaire-2 (23-items), which has acceptable psychometric properties among
youth. Each participant's social network will be assessed using the interview-administered social network survey to analyze
the social connections or ties of each participant in preparation for the next version of this study, which will allow
participants to participate and receive support from family members or friends. Information collected via the social network
survey will be used to calculate descriptive information on the number of ties the participant reports and the strength of
those ties, which will give us an overall measure of how weak or strong their social network is. This data will be unidentified
and aggregated. We will only collect first names and will never collect the address, phone number, or any other personal
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health information on any of the network ties reported by participants. There will be no attempts to identify or collect data
from any of the ties mentioned by participants.
Process Evaluation data will be collected to further evaluate the feasibility, assess the impact of implementation on study
outcomes, and identify mechanisms by which the intervention impacts health behaviors and BMI. We will use research
team logs and field notes entered into a REDCap online database to assess the recruitment of participants, resources
needed for intervention implementation, maintenance of the participants, implementation fidelity, the dose of intervention
delivered and received, and potential contamination.
All assessments will be conducted in a private room at a community center partners like Baker Ripley or at the home of the
participant. For safety, trained research assistants will travel in pairs for home-based data collection. They will notify their
supervisor Dr. Soltero of their time of arrival and departure at the participant's home. Additionally, we will provide
reimbursement for use of uber or other ride-share services.
Exit-Interviews. A subsample of participants (N=15) randomized to the intervention will participate in a 1-hour, post-
intervention exit interview
Data collection for this study has been concluded. The current database includes N-43 participants. To conduct further
analysis and maximize the potential knowledge to be gained from this study we will collaborate with students and faculty at
Rice Unviersity through the Data 2 Knowledge capstone program to conduct high-level analysis to identify patterns of 24-
hour physical activity and sleep behaviors and their associations with metabolic health. Data shared through this capstone
program will be de-identified and will include demographic information, accelerometer derived physical activity, sleep, and
sedentary behaviors, anthropometrics (BMI, heigh, weight, waist circumference), zipcode (not full address) as well as
surveys on autonomous motivation. An IRB protocol will be submitted at Rice University and all faculty and students
working on this project will be added to the IRB protocol at Rice University.
 
Section G:  Sample Size/Data Analysis
G1.  Sample Size
How many subjects (or specimens, or charts) will be used in this study?
     Local: 98              Worldwide: 98
Please indicate why you chose the sample size proposed:
     
Qualitative interviews will be conducted among 30 adolescents, 20 parents will be invited to complete a parent survey, and
48 adolescents will be recruited for participation in the intervention component. A formal power calculation was not used as
the primary purpose of this study is to examine feasibility, which is adequate for estimating feasibility parameters needed to
inform a fully powered intervention.
G2.  Data Analysis
Provide a description of your plan for data analysis. State the types of comparisons you plan (e.g. comparison of means,
comparison of proportions, regressions, analysis of variance). Which is the PRIMARY comparison/analysis? How will the
analyses proposed relate to the primary purposes of your study?
     All qualitative in-depth interviews and exit interviews will be audio-recorded, transcribed verbatim using a professional
transcription service, coded by two trained, independent coders, and qualitatively analyzed using NVivo version 9 (QSR
International, Cambridge, MA). Thematic content analysis will be used to identify emergent themes on participant
satisfaction and opportunities to improve the intervention.
Feasibility and process evaluation data will be collected to further evaluate feasibility, assess the impact of implementation
on study outcomes, and identify mechanisms by which the intervention impacts health behaviors and BMI. We will use
research team logs and field notes entered into a REDCap online database to assess the recruitment of participants,
resources needed for intervention implementation, maintenance of the participants, implementation fidelity, the dose of
intervention delivered and received, and potential contamination. Data recorded on the recruitment of participants will
include staff time, resources, strategies, and number of participants screened and enrolled. Data on resources for
implementation will include staff time, materials, and equipment used for implementation. Data on maintenance of
participants will include the number of text messages and calls sent to non-responsive participants and careful
documentation of dropouts and reasons for leaving the study. Implementation fidelity, dose delivered, and dose received,
will be defined by device wear, the number of technical issues (device or text message malfunction), and text message
engagement (number of text messages delivered, opened, and if participants respond when prompted). Potential
contamination will be assessed in the exit in-depth interview with intervention participants. Data on environmental factors
that could impact physical activity will be collected and analyzed using geographic information systems.
Analyses of Secondary and Tertiary Outcomes: Comparisons of PA, SB, sleep, BMI, waist circumference, blood pressure,
and heart rate between (Mann-Whitney U test) and within treatment groups (pre to post; paired t-tests, signed rank test)
will be tested. Cronbach's alpha will be used to assess the reliability of the psychological needs satisfaction and
autonomous motivation for PA scales. While clinically significant changes in secondary and tertiary outcomes are not
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expected, we will examine clinically meaningful effects and estimate the reliable change index. These analyses will guide
power calculations for future trials.
 
Section H:  Potential Risks/Discomforts
H1.  Potential Risks/Discomforts
Describe and assess any potential risks/discomforts; (physical, psychological, social, legal, or other) and assess the likelihood
and seriousness of such risks:
     
Risks associated with this study are classified as no greater than minimal risk. The primary risks of this study will be loss of
confidentiality. There is a small risk of causing adolescents or their family anxiety if the adolescent is identified as obese
and at high-risk for T2D. There is also a small risk of feeling discomfort when answering questions in qualitative interviews
or demographic surveys. This study has a small risk for injury or medical problems when youth increase or participate in
regular physical activity exercise (similar to a PE class) as they will be encouraged to do in this study. There are three
different SOP's in place for different adverse events that can occur to the participant throughout the study.The three SOP's
are for a participant receiving COVID-19 throughout the study, report an injury or if they show signs of psychological or
physical harm. If your child, receives COVID-19 or is injured while participating, we will provide them a sheet that will give
them steps of what to do in those incidents.
H2.  Data and safety monitoring plan
     Do the study activities impart greater than minimal risk to subjects?
          No
H3.  Coordination of information among sites for multi-site research
Is the BCM Principal Investigator acting as the SPONSOR-INVESTIGATOR for this multi-site research?
          No or Not Applicable
Is BCM the COORDINATING CENTER for this multi-site research?
          No or Not Applicable
 
Section I:  Potential Benefits
Describe potential benefit(s) to be gained by the individual subject as a result of participating in the planned work.
     
There may be no direct benefits to the participants. However, lifestyle interventions that promote physical activity and sleep
have been shown to improve metabolic health and reduce T2D risk in obese youth. The intervention is designed to
increase psychological needs satisfaction and youth may become more autonomously motivated to make healthy behavior
changes. These behavior changes may improve their weight status, reduce their body mass index, and could reduce their
risk for type 2 diabetes and other obesity-related diseases. Youth who participate in the wait-list control group may benefit
after the study ends, by being provided the opportunity to participate in the intervention. However, participants in either arm
may gain no direct benefit, as the study has not previously been tested for efficacy.
Describe potential benefit(s) to society of the planned work.
     
In light of the public health goal to decrease health disparities for Hispanic populations, this study has the potential to lead
to a program that can reduce obesity-related chronic conditions among Hispanic youth. Identifying novel ways to intervene
with this high-risk group is essential. This study will provide much needed information to society on delivering diabetes
prevention interventions to vulnerable Hispanic youth using technology-based strategies. This information is essential for
developing and implementing age- and culturally-appropriate diabetes prevention strategies that reach and engage this key
population to improve their metabolic health. The long-term trajectory of this work could significantly contribute to the
limited body of literature on evidence-based diabetes prevention interventions for high-risk, minority youth.
Do anticipated benefits outweigh potential risks? Discuss the risk-to-benefit ratio.
     
Potential risks are outweighed by the fact that the information gained will significantly advance the science regarding the
effects of sedentariness in an underrepresented population. This information, will inform the development of future lifestyle
interventions aimed at reducing sedentary behaviors to improve metabolic health in a high-risk, vulnerable population.
These intervention shave the potential for scalability and widespread dissemination which has the potential to reach
numerous communities and significantly improve health in the Latino population.
 
Section J:  Consent Procedures
J1.  Waiver of Consent
Will any portion of this research require a waiver of consent and authorization?
     No
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J1a.  Waiver of requirement for written documentation of Consent
Will this research require a waiver of the requirement for written documentation of informed consent?
     No
J2.  Consent Procedures
Who will recruit subjects for this study?
     PI
PI's staff
Describe how research population will be identified, recruitment procedures, any waiting period between informing the
prospective participant and obtaining consent, steps taken to minimize the possibility of coercion or undue influence and
consent procedures in detail.
     
Participants will be recruited from community clinics using the following strategies: 1) Monthly provider meetings at
collaborating clinics to encourage physicians to refer patients 2) On-site recruitment at clinical settings 3) Post study
information on the Texas Children's Hospital Primary Care Practice and Harris Health Pediatric Clinic social media sites
and inpatient newsletters. 4) Health fairs, immunizations fairs, back-to-school events, and any other community event, to
recruit participants in person. 5) Facebook advertising using a BCM approved lab page
Mothers or fathers will complete a release of information form at their pediatrician's office or during a health fair where we
recruit. We will use this information to contact them to provide more information about the study. If the family is interested in
participating, a telephone screening with the mother, father or legal guardian will be scheduled. If we cannot schedule a
phone screening then a self-screening survey will be texted or emailed to the participant, which will allow us to make
decisions regarding eligibility faster. After the self-screener is complete, a research team member will follow up via phone
to complete eligibility screening. During the screening call, we will use a scripted screening questionnaire that reviews the
inclusion and exclusion criteria for their child's participation. If inclusion criteria are met, we will then ask to speak directly to
the adolescent to explain the study, answer questions, and confirm their interest in participating. If the participant is to
participate in the first aim of the study, which includes an in-depth interview and feedback survey to help us develop text-
messages, then we will schedule their interview appointment which will take place in a private room at a public library or
community center. At the beginning of the interview appointment, prior to any study activities, informed consent will be
completed by the parent/legal guardian and informed assent will be obtained from the adolescent in English or in Spanish.
After the feedback survey we will conduct a (15-20mins) follow up phone interview to clarify survey responses . Due to the
addition of the follow up phone interview, we will call each participant and notify them of the changes to the procedure. If
they are interested in participating, we will send them a zoom link and a REDCap link to an electronic short form consent.
During the zoom call we will explain all procedures and answer questions. We will obtain their signature prior to conducting
the phone interview.
For youth who will participate in the Fitbit intervention portion of the study, they will complete the American College of
Sports Medicine 2015 exercise screener as part of their screening call to ensure that it is safe for him/her to engage in
physical activity. Once both the parent and adolescent agree to participate, they will be scheduled for their initial visit at the
clinic in which they were recruited to increase the accessibility of the study. At the initial visit, electronic informed consent
will be completed by the parent/legal guardian and electronic assent will be obtained from the adolescent through our
tablet. This will be given in their preferred language in English or in Spanish. Next, we will confirm the participant's BMI%
by measuring weight and height. If the adolescent qualifies, the remainder of the baseline data collection will be completed
and they will be enrolled in the study. In the consent form, youth will be notified that they must return the Fitbit device upon
completion of the intervention. For all consents and assents, the research coordinator will explain all study activities and
risks to the families and will ask three comprehension questions to check for understanding. Study information,
consent/assent, and data collection will be conducted in English and Spanish.
Are foreign language consent forms required for this protocol?
     Yes
Which of the following ways will you document informed consent in languages other than English?
     A full-length informed consent document
J3.  Privacy and Intrusiveness
Will the research involve observation or intrusion in situations where the subjects would normally have an expectation of
privacy?
     No
J4.  Children
Will children be enrolled in the research?
     Yes
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J5.  Neonates
Will non-viable neonates or neonates of uncertain viability be involved in research?
     No
J6.  Consent Capacity - Adults who lack capacity
Will Adult subjects who lack the capacity to give informed consent be enrolled in the research?
     No
J7.  Prisoners
Will Prisoners be enrolled in the research?
     No
 
Section K:  Research Related Health Information and Confidentiality
Will research data include identifiable subject information?
     Yes
Information from health records such as diagnoses, progress notes, medications, lab or radiology findings, etc.
     No
Specific information concerning alcohol abuse:
     No
Specific information concerning drug abuse:
     No
Specific information concerning sickle cell anemia:
     No
Specific information concerning HIV:
     No
Specific information concerning psychiatry notes:
     No
Demographic information (name, D.O.B., age, gender, race, etc.):
     Yes
Full Social Security #:
     Yes
Partial Social Security # (Last four digits):
     No
Billing or financial records:
     No
Photographs, videotapes, and/or audiotapes of you:
     Yes
Identifiable biospecimens
     No
Will identifiable biospecimens be stored for future research?
     NA
If yes, is the storage of biospecimens optional for subjects?
     NA
Will identifiable private information be stored for future research?
     NA
If yes, is the storage of information optional for subjects?
     NA
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Questionnaire, Survey, and/or subject diary
     NA
Other:
     
Yes, as described:
We will need participant's home address and phone number. We would also like to take pictures of your child to show
others how the study goes. To do this, we will need you and your child to sign an image consent form. This is not needed to
participate in this study. Also, in the event that you contract COVID-19 or disclose any evidence of physical or
psychological harm, parents and the appropriate medical and non-medical professionals will be notified and your child may
be withdrawn from the study. The Principal Investigator reserves the right to withdraw a participant for any reason deemed
necessary by the research team.
At what institution will the physical research data be kept?
     
Physical research data will be kept at Baylor College of Medicine. Physical Data containing demographic information will
be kept in a locked cabinet in a locked office. Electronic data will be kept in a secure server and will be password
protected.
How will such physical research data be secured?
     Physical Data containing demographic information will be kept in a locked cabinet in a locked office. Only the PI will have
direct access to the physical data.
At what institution will the electronic research data be kept?
     Electronic research data will be kept at Baylor College of Medicine. Electronic data will be kept in a secure server and will
be password protected.
Such electronic research data will be secured via BCM IT Services- provided secured network storage of electronic research
data (Non-Portable devices only):
     Yes
Such electronic research data will be secured via Other:
     No
Will there be anyone besides the PI, the study staff, the IRB and the sponsor, who will have access to identifiable research
data?
     No
Please describe the methods of transmission of any research data (including PHI, sensitive, and non-sensitive data) to
sponsors and/or collaborators.
     
Participant's phone numbers will be shared with Mosio, a secure text message platform; however, we will not use the
participant's name only their unique participant ID# to identify each participant.
We will collaborate with students and faculty at Rice University through the Data 2 Knowledge capstone program to
conduct high-level analysis to identify patterns of 24-hour physical activity and sleep behaviors and their associations with
metabolic health. Data shared through this capstone program will be de-identified and will include demographic
information, accelerometer derived physical activity, sleep, and sedentary behaviors, anthropometrics (BMI, heigh, weight,
waist circumference) as well as surveys on autonomous motivation. Data will be shared via encrypted files and sent
through an encrypted email. Only approved individuals will have access to the data. Once the data is at Rice University it
will be stored on a password protected computer on a secure server.
 
Will you obtain a Certificate of Confidentiality (COC) for this study?
     No
Please further discuss any potential confidentiality issues related to this study.
     There are no other potential confidentiality issue related to this study.
 
Section L:  Cost/Payment
Delineate clinical procedures from research procedures. Will subject's insurance (or subject) be responsible for research
related costs? If so state for which items subject's insurance (or subject) will be responsible (surgery, device, drugs, etc). If
appropriate, discuss the availability of financial counseling.
     The participant's insurance will not be responsible for the costs of the tests/analyses related to this study. There will be no
direct costs to the participants.
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If subjects will be paid (money, gift certificates, coupons, etc.) to participate in this research project, please note the total dollar
amount (or dollar value amount) and distribution plan (one payment, pro-rated payment, paid upon completion, etc) of the
payment.
Dollar Amount:
     200
Distribution Plan:
     The participating youth will receive compensation for their time and effort. The funds for compensation will be loaded onto a
ClinCard which will be given to participants in person.
 
Section M:  Genetics
How would you classify your genetic study?
     
Discuss the potential for psychological, social, and/or physical harm subsequent to participation in this research. Please
discuss, considering the following areas: risks to privacy, confidentiality, insurability, employability, immigration status, paternity
status, educational opportunities, or social stigma.
     
Will subjects be offered any type of genetic education or counseling, and if so, who will provide the education or counseling
and under what conditions will it be provided? If there is the possibility that a family's pedigree will be presented or published,
please describe how you will protect family member's confidentiality?
     
 
Section N:  Sample Collection
None
 
Section O:  Drug Studies
Does the research involve the use of ANY drug* or biologic? (*A drug is defined as any substance(other than food) that is
used to elicit a pharmacologic or physiologic response whether it is for treatment or diagnostic purposes)
     No
Does the research involve the use of ANY gene transfer agent for human gene transfer research?
     No
O1.  Current Drugs
 
Is this study placebo-controlled?
     No
Will the research involve a radioactive drug?
     No
 
Section P:  Device Studies
     Does this research study involve the use of ANY device?
          No
 
Section Q:  Consent Form(s)
The consent provides information on all research activities, including the risks and benefits, we will use to examine if
technology-based intervention can improve physical activity and sleep in Hispanic youth.
The consent provides information on all research activities, including the risks and benefits, which we will use to develop text-
messages that will be used to promote healthy activity and sleep behaviors among Hispanic adolescents.
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The consent provides information of the brief follow up interviews that we will be conducting regarding the text message
feedback survey. The purpose of this brief phone interview is to clarify any of the feedback information that is provided via the
survey to aid in the finalization of our text messages, which serve as the primary tool in the Fit24 intervention.
 
Section R:  Advertisements
None
 
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