Sleep in Adolescents - Pilot Study
Phase: NA
Conditions: Sleep
Sponsor: Rutgers, The State University of New Jersey

Version Number: 6.0 
Protocol Number: Pro2018000606 
PI Name: Dr. Andrea Spaeth 
Protocol Title: Sleep in Adolescents- Pilot 
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PROTOCOL 
 
 
 
STUDY INFORMATION 
Title of Project: Sleep in Adolescents- Pilot 
Principal Investigator: 
Name: Dr. Andrea Spaeth 
Division & Department: School of Arts and Sciences, The Department of Kinesiology and Health 
Contact Information: 
Phone Number: 848-932-0271 
Email: ams853@kines.rutgers.edu 
 
 
PROTOCOL VERSION NUMBER: 6.0 
DATE: 11/1/2022 

Version Number: 6.0 
Protocol Number: Pro2018000606 
PI Name: Dr. Andrea Spaeth 
Protocol Title: Sleep in Adolescents- Pilot 
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Table of Contents 
 
 
6.1 
Data Management and Confidentiality 
 
6.2 
Data Security 
6.3 
Data and Safety Monitoring 
 
6.4 
Reporting Results 
6.5 
Data Sharing 
7.0 
Data and/or Specimen Banking 
8.0 
Other Approvals/Authorizations 
9.0 
Bibliography 
1.1 
Purpose/Specific Aims 
1.2 
Research Significance 
1.3 
Research Design and Methods 
1.4 
Preliminary Data 
1.5 
Sample Size Justification 
1.6 
Study Variables 
1.7 
Specimen Collection As A Primary Source 
1.8 
Interviews, Focus Groups, or Surveys and/or Observations 
2.1 
Research Staff and Qualifications 
2.2 
Resources Available 
2.3 
Research Sites 
3.1 
Non-Rutgers Research Sites 
4.1 
Primary Data – Subjects and Specimens 
4.2 
Subject Selection and Enrollment Considerations 
4.3 
Subject Randomization 
4.4 
Secondary Subjects 
4.5 
Number of Subjects 
4.6 
Consent Procedures 
4.7 
Special Consent Populations 
4.8 
Economic Burden and/or Compensation 
4.9 
Risks and Benefits to Subjects 
4.10 
Secondary Data – Record/Chart Reviews, Databases, Tissue Banks, Etc. 
4.11 
Chart/Record Review Selection 
4.12 
Secondary Specimen Collection 
5.1 
Health Insurance Portability and Accountability Act (HIPAA) 
5.2 
Family Educational Rights and Privacy Act (FERPA) 
5.3 
NJ Access to Medical Research Act 
5.4 
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
6.0 
Research Data Protection and Reporting 
5.0 
Special Considerations 
4.0 
Research Data Source/s 
3.0 
Multi-Site Research Communication & Coordination 
2.0 
Project Management 
1.0 
Research Design 

Version Number: 6.0 
Protocol Number: Pro2018000606 
PI Name: Dr. Andrea Spaeth 
Protocol Title: Sleep in Adolescents- Pilot 
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1.0 Research Design 
 
 
1.1 Purpose/Specific Aims 
The purpose of this proposed pilot study is to test different recruitment approaches, examine the acceptability and feasibility of 3h 
sleep extension in 14-17 year olds, and determine if there are any issues with having adolescents wear the two devices we use to 
measure sleep and physical activity. 
 
A. Objectives 
The proposed study will serve as a pilot for a planned future study. In the future study, adolescents will be asked to increase 
time-in-bed (TIB) for sleep by ~3h/night in order to assess how sleep extension impacts markers of insulin sensitivity. 
 
B. Research Question(s) 
Aim 1: Determine the additional amount of sleep short-sleeping-adolescents (~7h TIB/night) will obtain when asked to 
increase time-in-bed to 10h/night for seven consecutive nights compared to those who are not asked to increase time-in- 
bed. 
Aim 2: Determine if adolescents are able to comply with study demands: wearing two devices (one on wrist and one on hip) 
and completing daily sleep diaries and call-ins for seven days. 
Aim 3: Acquire participant feedback regarding feasibility and acceptability of increasing TIB for sleep to 10h/night using a 
questionnaire and semi-structured interview. 
 
1.2 Research Significance 
Short sleep has become a significant health concern in adolescents; approximately 73% of adolescents in the U.S. self-report sleeping 
less than the recommended 8-10 h/night (1), and many exhibit irregular sleep patterns with short sleep during school nights and longer 
sleep on weekends (2). Observational studies reliably demonstrate a relationship between adolescent short sleep and adverse health 
outcomes (3-5). Therefore sleep interventions that successfully increase sleep duration are needed in this age group. Furthermore, 
adolescence may represent an important stage in the lifespan to target a sleep intervention as it is a developmental period during 
which lifestyle patterns – such as sleep, eating, and activity behaviors– are established and endure into adulthood(6). It is critical to 
first assess the feasibility and acceptability of increasing sleep duration in short sleeping adolescents prior to conducting a larger 
experimental study which will examine the impact of increased sleep on metabolic health outcomes. 
 
1.3 Research Design and Methods 
Adolescents (14-17y) will be recruited to participate in an observational pilot study. Participants will be asked to wear a sleep monitor 
on the wrist, a physical activity monitor on the hip, and complete a brief daily sleep diary and call-in procedure for 1 week. 
Approximately 15 subjects will be assigned to increase their time-in-bed for sleep by ~3h per night and 15 subjects will maintain their 
normal sleep schedule. The proposed study will incorporate a mixed-methods approach to gather information about the feasibility of 
implementing a similar sleep protocol in a future study. 
 
A. Screening Interview: Participants will undergo a phone screen which will be carried out by the trained study coordinator 
or a research assistant. During the phone screen, participants will be asked to provide oral consent so information can be 
recorded to determine participant eligibility. If participants are determined to be eligible, they will be invited by the study 
staff to the sleep center for an orientation to the study. Prior to scheduling families, research staff will ensure that there are 
no planned family vacations, changes in typical family routine that might impact sleep (e.g., planned sleepovers), or current 
minor illness(e.g., colds) that might disrupt sleep or result in the child needing to take medications that might impact sleep. 
The study will be timed around family’s schedules to maximize adherence to study protocol. Subjects who expressed interest 
to participate in future research studies will be screened again to determine eligibility following modification 
Mod2018002469 to the study protocol. Only subjects who gave permission to be contacted again will be screened again. 
 
Orientation: When the family arrives to the sleep center, study staff will first collect additional eligibility information (height 
and weight measurement, additional information about the adolescent’s typical sleep, availability to complete study 

Version Number: 6.0 
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PI Name: Dr. Andrea Spaeth 
Protocol Title: Sleep in Adolescents- Pilot 
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schedule). Note: if the subject is not eligible based on BMI, the height and weight data will be destroyed immediately. If the 
adolescent is eligible, study staff will provide an overview of the study and will review the Informed Consent/Assent forms 
with the family. 
 
Participants will be asked to provide written informed consent/assent prior to data collection. After participants agree to 
participate and are enrolled in the study, participants will complete the followingquestionnaires: 1) Children’s Chronotype 
Questionnaire (7), 2) Demographic Questionnaire, 3) Sleep Disorders Inventory for Students- Adolescents (SDIS-A) (8) 4) 
Mood Questionnaire (9), the Perceived Stress Scale (10) and the Freiburg Mindfulness Inventory (11) (NOTE: questionnaires 
will be converted to an online format using Qualtrics, an online survey platform). Participants will also complete a battery of 
cognitive tests during the orientation to assess how sleep affects cognitive function (12). A final check for eligibility (based on 
the sleep disorder questionnaire) will be conducted. Adolescents who remain eligible will be provided with wrist actigraphs, 
waist accelerometers and sleep diaries and instructed on their use for the next 7 days. To assist in scoring the actigraphs, 
participants will be asked to call a time-stamped voice mail (or text) twice daily: before bedtime and when they wake up. 
Research staff will follow up with families who do not call in or text. 
 
A consistent wake time will be established with families randomized to the 10 h time-in-bed condition based on the 
adolescents’ typical schedules. Bedtime will then be calculated as 10 h prior to wake time. Families will be provided with 
handouts (See Tasks Overview for Families) that explicitly state the participant’s bedtime and wake time for each day during 
the sleep schedule to ensure adherence to the protocol. Research staff will also discuss the participant’s bedtime routine and 
will ask that participants begin that routine with the sufficient time so that it can be completed prior to the prescribed 
bedtime. Research staff will reiterate that the participant must be lying in bed with the lights out at the prescribed bedtime, 
and that an alarm clock should be set for the prescribed wake time. Parents will also be asked to ensure that the adolescent 
goes to bed and wakes up (and gets out of bed) on time. Participants will be instructed to remain in bed with the lights off 
even if they have difficulty falling asleep or wake up earlier than the prescribed wake time. Participants must refrain from 
engaging in any activity (e.g., reading a book or engaging in social media) during the prescribed TIB. 
 
Handouts (See Sleep Health Education Information Sheet) on sleep hygiene practices (i.e., strategies to ensure a good night’s 
sleep) will be reviewed and provided to families. These include a list of caffeinated foods/beverages to avoid after 2pm, not 
watching TV, using computer/smartphone/tablet or play video games as part of the bedtime routine, and ensuring that the 
adolescent has a quiet, cool, and dark sleep environment. Research staff will discuss potential barriers to following the 
protocol and provide strategies to overcome these barriers (e.g., providing participants with an eye mask to block out excess 
light, discussing the use of fans or white noise machines to decrease noise, turning phone/tablets off or giving these devices 
to parents when it is time for bed and recording TV shows that begin late at night). 
 
Subjects who are randomized to the control condition will be asked to maintain their typical bedtime and wake times. These 
subjects will be instructed to wear wrist actigraphs, waist accelerometers, complete sleep diaries and call-ins for 7 days. 
Handouts and resources on sleep hygiene practices will be reviewed at the end of the study. 
 
Study staff will conclude the orientation session by answering any remaining questions that the family has and scheduling 
the follow-up visit. 
 
Week-long study protocol: Participants are instructed to wear the sleep monitor (on wrist) 24h a day for the entire 7 day 
period and to wear the physical activity monitor (on hip) during all waking hours for the entire 7 day period. Participants will 
be given a 7-day sleep diary to complete daily. This provides an additional monitor of sleep which assists in analysis of wrist 
actigraph data and serves as an effective behavioral strategy to increase adherence to the protocol via self-monitoring. 
Participants will also be asked to call in twice daily (just prior to bedtime and upon waking in the morning) to a time-stamped 
voice mail box or send a text to the study’s Google voice account. If a family fails to call in/text or calls in bed bed/wake times 
are outside prescribed times, research staff will follow-up with families by phone to ensure protocol adherence. Research 
staff will also maintain a rolling calculation of adherence to the sleep schedule for subjects asked to complete 10h TIB. 

Version Number: 6.0 
Protocol Number: Pro2018000606 
PI Name: Dr. Andrea Spaeth 
Protocol Title: Sleep in Adolescents- Pilot 
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Follow-Up Visit: The participant and his/her parent will return to the sleep center approximately 1 week after the orientation 
to return the wrist actigraph, waist accelerometer and sleep diary. Study staff will administer an accelerometer question form 
and an actigraph question form to inquire about any discrepancies in recorded diary entries, actigraphy data and call-in log 
information. This will take place in the form of a semi-structured interview. Additionally, participants will be asked to repeat 
the mood questionnaires, Perceived Stress Scale and the Freiburg Mindfulness Inventory (11)complete an exit-survey 
(Acceptability/Feasibility Questionnaire) and semi-structured interview related to their overall impressions of the study to 
gain more information about study feasibility. The cognitive battery will be administered again for assessment of cognitive 
function after prescribed bed-time (12)/control condition. Participants will be provided $10 for each 24-hour period that 
they follow study procedures. Specifically, each night that they call/text prior to getting into bed, get into bed at their 
prescribed bedtime (i.e., the actigraph is consistent with the reported bedtime), call/text in the morning right when they 
wake and get out of bed at the prescribed wake time (i.e. the actigraph is consistent with the reported wake time), the 
participant will earn $10 (total possible: $70). Our research team has found that this strategy results in very high adherence 
to experimental sleep protocols. 
 
B. Participants will be asked to participate in a phone-screening interview (15-20 minutes). If initially determined eligible by 
the phone screen, participants will be invited to visit the sleep center for a study orientation (1.5-2 hours). During the 
orientation, informed consent will be obtained (10-20 minutes). Participants will be asked to wear a wrist actigraph and waist 
accelerometer for the week following orientation (1 week). Participants will be expected to wear devices during the entire 
week as well as call a time-stamped voicemail during wake and bed times and complete sleep diaries daily. Participants will 
be asked to report to the study center approximately one week after the orientation date for a follow-up visit (1-1.5 hours) 
to deliver devices, undergo a semi-structured interview about the sleep data that was collected, and provide study staff with 
feedback regarding the study. 
 
1.4 Preliminary Data 
N/A: Adherence to changes in sleep duration as prescribed in a sleep protocol has not been studied in adolescents. 
 
1.5 Sample Size Justification 
The proposed study’s purpose is to serve as a pilot study to gain exploratory data on approximately 30 adolescents to explore sleep 
health study feasibility in New Brunswick, New Jersey. Therefore, power analysis was not performed. 
 
1.6 Study Variables 
 
A. Independent Variables, Interventions, or Predictor Variables 
 
The proposed study is a pilot to assess the feasibility of increasing adolescent time-in-bed for sleep to 10 h/night for seven 
consecutive nights. Individuals who regularly sleep 7h/night will be recruited to participate in the research study. A sleep 
protocol will be implemented to either increase individual sleep by ~3 h/night or maintain a typical sleep schedule. Study 
staff will work with the participants to determine a bedtime wake time schedule that will increase number of hours from 
7h/night to 10h/night. The purpose of this research is to gain new information about sleep study feasibility. 
 
B. Dependent Variables or Outcome Measures 
 
Sleep: Sleep will be monitored using the Actiwatch Spectrum Plus (Phillips Respironics, Murrysville, PA). Wrist actigraphy is a 
widely used, reliable and valid approach for measuring sleep (13-15). The device is worn on the non-dominant wrist across 
the 24-hour period and monitors motor activity to obtain continuous recordings of sleep-wake states. In this study, the device 
will be configured to store data in a 1-minute epoch in accordance with pediatric reliability and validity studies (13, 16). 
Epochs are scored as sleep or wake by Actiware 6.0 software using an algorithm that modifies activity counts during a single 
epoch by activity produced in the surrounding two minute time period (16). The primary variable of interest is the actigraph 

Version Number: 6.0 
Protocol Number: Pro2018000606 
PI Name: Dr. Andrea Spaeth 
Protocol Title: Sleep in Adolescents- Pilot 
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11/4/2022 
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measured sleep period, which is the period between actigraph-estimated sleep onset and wake. Participants will be asked 
to press a button on the device when they go to bed and once when they wake up. Additionally, daily call-ins will provide an 
additional measure of bedtime and waketime and daily sleep diaries will be used to collect participants’ estimate of bedtime 
and wake time, awakenings during the night, and daytime sleep (i.e. naps). This information is critical for verifying and scoring 
actigraphy data and provides an additional measure of sleep duration. 
 
Physical activity: Physical activity will be tracked using the Actigraph GT3X (ActiGraph Corp, Pensacola, FL). Hip-worn 
accelerometry is a reliable and valid objective assessment of physical activity in adolescents (17, 18). Participants will be 
instructed on how to wear the device (device placement, only to wear during waking hours, whether the device can be worn 
in water etc.). Standard procedures for scoring (i.e. number of valid days, minimum amount of daily wear time needed and 
detection of non-wear time) and an established algorithm for determining the amount of time spent in moderate/vigorous 
activity will be used (17). For this pilot study, the primary variable of interest is daily wear time. 
 
Acceptability/Feasibility: The acceptability and feasibility of increasing time in bed for sleep to 10h/night will be assessed with 
a questionnaire and a semi-structured interview to follow up on participant questionnaire responses. Of interest will be the 
participant’s perceptions of 1) how challenging obtaining more sleep is during school nights is, 2) benefits they experienced 
as a result of sufficient sleep; and 3) what type of messaging and strategies should be used in a future sleep intervention. 
These responses will guide future studies examining the effect of sleep extension on metabolic health and aid in the 
development of sleep intervention in adolescents. The research team has successfully used this multi-method approach in 
previous studies. Research staff will also maintain a rolling calculation of adherence to time-in-bed with sufficient adherence 
defined as ≥85% of the prescribed time-in-bed. 
 
1.7 Specimen Collection as a Primary Source 
N/A 
 
1.8 Interviews, Focus Groups, Surveys, and/or Observations 
 
A. Administration 
At the follow-up study visit, participants will complete a semi-structured interview with study staff to go over the previous 
week’s sleep data. Specifically, study staff will download the sleep actigraph data and print out a summary of the actigraph- 
determined periods of sleep, rest, and wake as well as anytime the device was considered to be “off-wrist”. Study staff will 
compare this data with sleep diary responses and call-in information. Any discrepancies will be reviewed with the 
participant and off-wrist periods will be confirmed or explained. Similarly, study staff will review wear the hip-worn device 
data to determine when the device was taken off, and reasons for being off. In addition, participants will complete a 
feasibility/acceptability questionnaire and then undergo a semi-structured interview with study staff to follow up on the 
responses in order to inquire about the participant’s overall study experience and gain more information about sleep in 
adolescents to inform future studies. Study staff (study coordinator and research assistant) will be responsible for 
administering questionnaires and the PI will oversee all operations. 
 
 Timing and Frequency 
Semi-structured interview regarding device data will occur at the follow-up visit, and is expected to last 
approximately 30-45 minutes. 
Feasibility/acceptability questionnaire and follow-up interview will also occur during the follow-up visit and is 
expected to take approximately 10-15 minutes. 
 
 
 
 Location 

Version Number: 6.0 
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A closed-door office space will be used to ensure participant confidentiality and privacy in Loree Classroom 
Building on Rutgers Cook/Douglass campus. 
 
 Procedures For Audio And Visual Recording 
N/A 
 
 Person Identifiers 
Subjects will be asked for their name and phone number for scheduling/recruitment purposes only. The study 
coordinator and PI will be the only research staff members that have access to person identifiers during the entire 
duration of the study. Participant person identifiers will be stored in a separate location from any study-related 
data. During the informed consent process, we will ask subjects and their parent(s) if they would like to be 
contacted in the future to be recruited for additional sleep studies. A separate section and checkbox will be 
included on the Parental Informed Consent form. Identifiable information will be stored in a separate database 
from the experimental data. Subject ID numbers will be assigned and used for data collection and analysis. For 
those who do not consent to be contacted in future studies, identifiers will be destroyed after completion of the 
study, or, in the event a participant does not continue with the study, after withdrawal from study participation. 
 
B. Study Instruments 
 
Note: Study instruments will be converted to an online format using the Qualtrics survey platform. Supporting 
documents can be found in the eIRB submission 
 
 Anthropometrics: At the orientation, participant’s height (wall-mounted stadiometer, measured in duplicate) 
and weight (digital scale, measured in duplicate) will be measured using standard procedures (participant 
wearing street clothes, without shoes). Theses measure will be converted to BMIz and BMI percentile using age 
and sex-adjusted normative data from the CDC(18). 
 
 Demographic Questionnaire: At the orientation, participants (with assistance of parents as necessary) will 
complete a demographic questionnaire which will include the following information: participant age, gender and 
racial and ethnic group, parent education and occupational status. 
 
 Child Chronotype Questionnaire: At the orientation, participants will complete this questionnaire (7) in order to 
determine his/her chronotype. In adolescents, evidence suggests that chronotype, an individual’s preference for 
activity early (morning-type, “lark”) versus late (evening-type, “owl”) in the day, affects sleep, diet and weight 
status (19, 20) which will be important information for planning the future metabolic health study. 
 
 Sleep Disorders Inventory for Students-Adolescents (SDIS-A): At the orientation information obtained from this 
questionnaire (8) will determine if the adolescent is eligible for participation in the study. If a participant’s score 
indicates that he/she may be at risk for a sleep disorder, the family will be referred to the Robert Wood Johnson 
Sleep Clinic, and the adolescent will not be eligible to participate in the study. 
 
 Mood questionnaire: The Profile of Mood States Second Edition (POMS 2) instruments assess the mood states 
of individuals 13 years of age and older. The instrument is a self-report scale that allows for the quick 
assessment of transient, fluctuating feelings and enduring affect states(9). 
 
 Perceived Stress Scale: The Perceived Stress Scale (PSS) measures the degree to which situations in one’s life are 
considered stressful (10, 21). Previously, the PSS was designed for use in a population with at least a junior high 
school education. The questions are general in nature and easy to understand. 

Version Number: 6.0 
Protocol Number: Pro2018000606 
PI Name: Dr. Andrea Spaeth 
Protocol Title: Sleep in Adolescents- Pilot 
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 Freiburg Mindfulness Inventory: The Freiburg Mindfulness Inventory (FMI) is a consistent and reliable scale used 
to measure mindfulness, and it has previously been validated for use in research and clinical applications to 
appropriately measure mindfulness(11, 22). 
 
 Actiwatch Spectrum Plus (Phillips Respironics, Murrysville, PA): During the week between the orientation and 
follow-up visits, participants will wear the device on their non-dominant wrist across the 24-hour period. The 
device monitors motor activity to obtain continuous recordings of sleep-wake states (See Actiwatch and 
Accelerometer Information attachment for picture and spec sheet). 
 
 Sleep Diary: During the week between the orientation and follow-up visits, participants will complete entries in 
a brief sleep diary daily. This provides a participant’s estimate of bedtime and wake time, awakenings during the 
night, and daytime sleep (i.e. naps). 
 
 Actigraph GT3X (ActiGraph Corp, Pensacola, FL): During the week between the orientation and follow-up visits, 
participants will wear the device (which is on a belt) on their right hip during waking hours. Motor activity is 
obtained in order to determine how much time the participant spends in sedentary, moderate and vigorous 
activity (See Actiwatch and Accelerometer Information attachment for picture and spec sheet). 
 
 Acceptability/Feasibility Questionnaire: At the follow-up visit, participants will complete a brief questionnaire 
asking about their experience with the research study. Study staff will then conduct a semi-structured interview 
with the participant to follow-up on their responses. 
 
 Battery of Cognitive Tests via Joggle Research Application:  During the initial and follow-up visit a battery of 
cognitive tests will be administered to participants using Joggle, which is an iPad application(12). The first test is 
Motor Praxis Task (MPT), where boxes pop up in different places across the screen and will only disappear when 
tapped. Next is Visual Object Learning Task (VOLT), where participants are shown a set of shapes, and need to be 
able to recall the previous shapes when they are mixed in with new shapes. The NBACK test is a test where images 
are shown in a certain order and the participant needs to be able to pick an image that they had seen a certain 
number of screens before. Abstract Matching (AM) is a test where participants are shown a single shape, and 2 
pairs of shapes, and needs to choose which pair fits the original shape. Line Orientation Test (LOT) is a test where 
participants need to rotate a line using the shortest path, so it will be parallel with another line. Digital Symbol 
Substitution Task is where participants are shown a list of numbers that correspond to symbols, and when they 
are shown a single symbol, they need to select the corresponding number. Balloon Analog Risk Task (BART) is a 
test where participants need to inflate the balloon on the screen to maximize the reward, but will receive nothing 
if the balloon pops. The last test is the Psychomotor Vigilance Test (PVT), participants are shown random stimuli 
and cannot respond early. The total battery will take approximately 20 minutes to complete and will be performed 
in a closed-door office space with minimal distraction. Trained research staff will be present to answer questions 
about the application. 
 
2.0 Project Management 
 
 
2.1 Research Staff and Qualifications 
 
Principal Investigator: Andrea Spaeth, Ph.D. is a tenure-track Assistant Professor in the Department of Kinesiology and Health at 
Rutgers University. Dr. Spaeth has been conducting sleep research for the past 6 years and has professional training in monitoring 
sleep using actigraphy, tracking physical activity using accelerometry and conducting experimental sleep research. 
 
Study Coordinator: Taylor McCoy has over 2 years experience working in human subject research. She has experience 
using the equipment in this protocol and in obtaining informed consent and conducting experimental study procedures. 

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2.2 Resources Available 
 
A. Facilities 
Orientation and follow-up visits will be held at an office on the Cook/Douglass campus of Rutgers University. A closed-door 
office space will be used to screen participants for eligibility and describe study related procedures. 
 
 
B. Medical or Psychological Resources 
Participants will be asked to complete a sleep disorders questionnaire. In the event a participant achieves a score that 
excludes them from the study, we will provide the participant with a referral to the Robert Wood Johnson Sleep Clinic. 
 
C. Research Staff Training 
All members of the study staff will undergo mandatory clinical research IRB training as requested by Rutgers University. The 
study coordinator will be trained in informed consent/assent, protocol and research related procedures prior to the 
initiation of study-related tasks. Ongoing training will be administered to ensure that the study coordinator is competent in 
his/her duties and functions. Research assistants will be trained by the study coordinator and all trainings will be 
documented to ensure the appropriate trainings are delivered to staff persons working on study procedures. 
2.3 Research Sites 
 
1) 
Rutgers Sleep Lab 
Department of Kinesiology and Health, Rutgers 
The State University of New Jersey 
Loree Classroom Building Office 018 
72 Lipman Drive 
New Brunswick, NJ 08901 
 
3.0 Multi-Site Research Communication & Coordination 
 
N/A 
 
3.1 Non-Rutgers Site Research 
N/A 
 
4.0 Research Data Source/s 
 
 
4.1 Primary Data: Subjects and Specimens 
Primary data will be collected from subjects in this study. Subjects will consist of adolescents age 14-17y in the greater New 
Brunswick, NJ area. 
4.2 Subject Selection and Enrollment Considerations 
 
A. Recruitment Details 
Following IRB approval, subjects will be recruited from the greater New Brunswick, New Jersey area. Advertisements will be 
posted in the local community (e.g., at community centers, YMCAs, boys and girls clubs, libraries, high schools etc.) and on 
Rutgers University and Robert Wood Johnson Medical School campuses. We will seek approval from all locations before 
posting advertisements. 
 
B. Source of Subjects 
Participants will be recruited from the greater New Brunswick, New Jersey area. 

Version Number: 6.0 
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PI Name: Dr. Andrea Spaeth 
Protocol Title: Sleep in Adolescents- Pilot 
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C. Method to Identify Potential Subjects 
Individuals will be screened for eligibility via a phone screen to minimize participant travel-burden to the study center. 
Upon arriving to the study center for the orientation visit, additional checks for eligibility (BMI, typical sleep and availability 
to complete the study) will be completed initially to avoid wasting the time of ineligible participants. Those that meet the 
inclusion/exclusion criteria and are considered eligible for the study will be provided with an overview of the study, the 
informed consent process, and asked if they would like to enroll. Enrollment will occur at the study orientation. 
 
In accordance with the protocol modification Mod2018002469, subjects who were previously screened and determined 
ineligible based on weight status alone will be rescreened. Subjects who previously completed the phone screening 
questionnaire were asked if they would like to be contacted for future research studies. Only those who gave permission to 
be contacted will be contacted and rescreened. 
 
D. Subject Screening 
 
A brief online screening questionnaire will be used for subjects who express interest in the research study. The online 
screening form will include the following topics: contact information, subject age, availability to complete the study, sleep 
habits. 
 
After the study staff receives contact information from an interested individual, the individual will be contacted for a phone 
screen. The subject’s parent will be asked to provide oral consent over the phone during the primary screening process to 
obtain confidential information related to eligibility and orientation scheduling. The parent will be read a statement of 
confidentiality (See Screening Script). A list of the items that will be covered in the screening interview will be read to the 
parent to ensure that the parent is aware of the screening process and the questions that are going to be asked of them. 
Study staff will ask the parent if they have questions or concerns prior to asking for oral permission and proceeding with 
screening-related questions. The study staff will ask the parent for permission to document identifiable information related 
to the subject’s eligibility in the study. Verbal consent to the screening protocol will be documented on the Screening Script. 
The person obtaining oral consent will also sign and date this form. Initial eligibility will be determined using this screening 
tool and minimizes subject burden to the study location for the secondary screening and orientation. The phone screening 
script includes self-reported information including age, approximate weight and height of the child, availability to complete 
the study and current sleeping patterns. 
 
Subjects who were previously screened for the research study will be screened again with an abbreviated screening form to 
capture transient data that may have changed from the initial screen (See Abbreviated Phone Screen). This abbreviated 
phone screen will include the following information: age, height and weight status, sleep habits, current enrollment in 
another research study and caffeine use. The research staff will provide the subject with both the study description and the 
confidentiality statement. Permission to document all variables will be obtained from the subject’s parent. 
 
Eligible individuals will be invited to the sleep center for an orientation. A secondary screening process will be needed to 
determine further eligibility (See Orientation Eligibility Form). We anticipate that a secondary screening process prior to the 
full written informed consent/assent process will minimize subject burden. Oral consent and assent from both the parent 
and child will be documented on a secondary screening document by the research coordinator/research assistant(s) to 
carry out procedures for additional checks for eligibility (measured BMI, typical sleep and availability to complete the study, 
complete the SDI-S questionnaire). These procedures are outlined in the Orientation Eligibility Form, which will be used to 
inform the parent and child about the orientation screening procedures. Study staff will ensure that the parent and child do 
not have any follow up questions or concerns. After oral consent and assent is obtained from both the parent and child, the 
research staff member who delivered this information will sign and date the form. 

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Following the additional screening procedures highlighted above, eligibility will be determined by the study staff based on 
inclusion/exclusion criteria. Eligible subjects will be asked to complete the written Parental Informed Consent Document 
and Assent of Participation in Research Activities Document before further research procedures can take place (See 
Consent section for further details on consent/assent process). 
 
 Inclusion Criteria 
1. 
Parent-reported child age of 14-17 years 
2. 
Typical sleep duration of approximately 7hr/night on school nights 
3. 
BMI for age and gender in the >5th percentile but not greater than 100% overweight. 
4. 
Parent must be the primary caretaker and at home during bed/wake times 
5. 
Reported willingness and ability to complete all study-related tasks, including wearing the wrist actigraph 
and hip accelerometer daily. 
 
 Exclusion Criteria 
1. 
Diagnosable sleep disorder (including Sleep Disordered Breathing) based on parent report and 
participant’s score on Sleep Disorders Inventory for Students-Adolescents (SDIS-A). 
2. 
Medication use or parent-reported diagnosis of a serious medical condition (including psychiatric 
conditions) that may impact sleep. 
3. 
Excessive intake of caffeine (>300mg/day), drug (including nicotine) or alcohol use, or a history of 
substance abuse. 
4. 
Actively trying to lose weight. 
5. 
Transmeridian (east-west/west-east) travel during past month or planned travel during study time frame. 
6. 
Inability to understand or complete protocol to ensure that consent/assent and reliable and valid 
measures are obtained. 
7. 
Sibling of enrolled subjects, to minimize risk of bias in study findings. 
 
E. Recruitment Materials 
Printed flyers will be distributed across the Rutgers University campus. Additionally, we may reach out to local high schools, 
boys and girls clubs, libraries and YMCAs to advertise with printed flyers. Final versions of the print advertisements will be 
included for review, and we will seek posting approval from all locations prior to posting. 
 
F. Lead Site Recruitment Methods 
N/A 
 
4.3 Subject Randomization 
Condition assignments will be created by the PI and placed in sealed envelopes. Envelopes will be opened during the orientation visit 
by the study coordinator (there will be n=15 control and n=15 increase to 10h time-in-bed). 
 
4.4 Secondary Subjects 
N/A 
 
4.5 Number of Subjects 
 
A. Total Number of Subjects 
We anticipate 30 total subjects to enroll in this pilot study. 
 
B. Total Number of Subjects If Multicenter Study 
N/A 

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4.6 Consent Procedures 
 
A. Consent 
 
 Documenting Consent 
 
The subject’s parent will be asked to provide oral consent over the phone during the primary screening process to 
obtain confidential information related to eligibility and orientation scheduling. The parent will be read a 
statement of confidentiality (See Screening Script). A list of the items that will be covered in the screening 
interview will be read to the parent to ensure that the parent is aware of the screening process and the questions 
that are going to be asked of them. Study staff will ask the parent if they have questions or concerns prior to asking 
for oral permission and proceeding with screening-related questions. The study staff will ask the parent for 
permission to document identifiable information related to the subject’s eligibility in the study. Verbal consent to 
the screening protocol will be documented on the Screening Script. The person obtaining oral consent will also sign 
and date this form. Initial eligibility will be determined using this screening tool and minimizes subject burden to 
the study location for the secondary screening and orientation. The phone screening script includes self-reported 
information including age, approximate weight and height of the child, availability to complete the study and 
current sleeping patterns. 
 
Eligible individuals will be invited to the sleep center for an orientation. A secondary screening process will be 
needed to determine further eligibility (See Orientation Eligibility Form). We anticipate that a secondary screening 
process prior to the full written informed consent/assent process will minimize subject burden. Oral consent and 
assent from both the parent and child will be documented on a secondary screening document by the research 
coordinator/research assistant(s) to carry out procedures for additional checks for eligibility (measured BMI, 
typical sleep and availability to complete the study, complete the SDI-S questionnaire). These procedures are 
outlined in the Orientation Eligibility Form, which will be used to inform the parent and child about the orientation 
screening procedures. Study staff will ensure that the parent and child do not have any follow up questions or 
concerns. After oral consent and assent is obtained from both the parent and child, the research staff member 
who delivered this information will sign and date the form. 
 
Following the additional screening procedures highlighted above, eligibility will be determined by the study staff 
based on inclusion/exclusion criteria. Eligible subjects will be asked to complete the written Parental Informed 
Consent Document and Assent of Participation in Research Activities Document before further research 
procedures can take place (See Consent section for further details on consent/assent process) 
A parental informed consent document will be used to obtain consent from the parent of the participant. 
Additionally, because we are recruiting children, every child will be asked to provide assent and will sign the assent 
document to declare assent to research study procedures. 
 
Document List: 
a. Parental Informed Consent Document 
b. Assent for Participation in Research Activities Document 
 
On the consent form, we ask parents to indicate if they are willing to be contacted in future research studies. If a 
parent initials ‘Yes, I agree to be contacted about future research studies,’ we will provide them with a Contact 
Form which will include the name of parent, the name of the participant, the date as well as the preferred contact 
method. Parents and participants will be informed that in the event there is another research study they can 
participate in, the study staff will contact the family using the information provided on the Contact Form. The 

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Contact Form is the only document used to revisit families that documented interest in participation in additional 
research studies at Rutgers Sleep Lab. 
 
 Waiver of Documentation Of Consent 
N/A 
 
 Waiver or Alteration of Consent Process 
N/A 
 
6. 
7. Consent Process 
 
 
Location of Consent Process 
The consent process will take place in Loree Classroom Building in a closed-door office space. 
 
 
Roles for Individuals Involved in Consent 
The study coordinator will be responsible for obtaining written consent/assent at the initial orientation visit 
from both the parent and the child. 
 
 
Coercion or Undue Influence 
The consent process is anticipated to take approximately 10-20 minutes, or as long as the participant needs to 
make an informed decision about participation in the study. All individuals involved in the informed 
consent/assent process will be educated that their participation in the research study is completely voluntary. 
Participants will be reminded that they have the ability to withdraw at any time and that their decision to 
participant will not have any impact on their availability of care. All study-related information will be clearly 
communicated and in writing in an organized fashion with understandable language. Exculpatory language will 
not be used in written consent or discussions about research. 
 
4.7 Special Consent/Populations 
 
A. Minors-Subjects Who Are Not yet Adults 
 
 
Criteria for Consent of Minors 
Parents will be asked to report the age of their child prior to study enrollment. This research study will focus 
on adolescents (14-17 y), and therefore, we expect a parent to be available and present at all study meetings. 
 
a. Wards of the State 
N/A 
 
b. Research in NJ Involving Minors 
This research involving children will pose no more than minimal risk to the participants. Permission of 
one parent is sufficient event if the other parent is alive, known, competent, reasonably available, and 
share legal responsibility for the care and custody of the child. Assent to research procedures will be 
obtained from all children. The investigators will obtain assent on the Assent for Participation in Research 
Activities Form. The child will print, sign and date the assent form. Parental consent will be obtained using 
the Parental Informed Consent Form. The name of the child will be printed on the form, and the parent 
will print, sign and date the form. The person obtaining consent will sign and date both the parental 
consent and assent forms before enrollment can occur. 

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c. 
Research Outside of NJ Involving Minors 
N/A 
 
 
Parental/Guardian Permission 
Participants in our study will be between the ages of 14-17 years. Therefore, parental permission to 
participate in the research study will be required. 
 
 
Assent Process 
During the orientation, trained study staff will go through the consent document with the parent. The parent 
will have the opportunity to ask questions about the study. Next, the stuff staff member will review the assent 
form with the child to ensure that the child has a clear understanding of the study procedures. Research staff 
members will ask the child if they have any questions or concerns related to the study protocol. The study staff 
will remain engaged with both the child and the parent during the entire duration of the consent/assent process. 
Following review of the consent and assent documents, the parent and child will have the opportunity to discuss 
the study. After the decision is made, and the study staff ensures that all questions and concerns have been 
addressed, the parent will be asked to sign the consent document and the child will be asked to sign the assent 
document. We will obtain assent for all children who have parent consent to research participation. Individuals 
will be asked about any questions or concerns they may have prior to assent and also be made aware that their 
participation is completely voluntary. 
 
a. 
Documentation of Assent 
Trained study staff will review the assent form with the child while the parent is present. Assent will be 
considered documented after the child prints, signs and dates the Assent for Participation in Research 
Activities Form. 
 
B. Non-English Speaking Subjects 
N/A 
 
C. Economic Burden and/or Compensation for Subjects 
 
 Expenses 
The only expense that participants are anticipated to accrue as a direct result of participation in this study is the 
cost of travel to the sleep center. 
 
 
Compensation/Incentives 
At the end of the follow-up visit, when devices have been returned, participants will be compensated ($10/day = 
maximum $70 for their participation in the study according to protocol adherence (payments will be made in the 
form of a giftcard). 
 
 
Compensation Documentation 
Participants who adhere to the protocol guidelines described at the orientation will receive a receipt of the payment 
and study staff will make copies of these receipts. Receipts will be stored in a locked filing cabinet in a locked office. 
 
D. Risks and Benefits to Subjects 
 
 Description of Subject Risk 

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The sleep study procedures pose minimal risk to participants. Participants will be asked to wear sleep monitoring 
and physical activity devices, and there is a rare risk (estimated at 1 out of 100 persons) that the devices may cause 
irritation to the skin or be slightly uncomfortable to wear. 
 
Participants may experience travel inconvenience, as they are asked to travel to the study center for orientation and 
the follow-up visit. We will ask participants to complete sleep diaries and complete daily call-ins to report sleep 
patterns, which may serve as a small inconvenience to participant participation. Half of participants will be asked to 
increase their sleep to 10 h/night. A change in sleep patterns, bedtime routine or wake routine may be an 
emotionally charged or negative psychological experience for the subject and/or their families. 
 
Participants will be asked to complete a sleep disorder questionnaire upon study enrollment to determine if they 
have a sleep disorder that would hinder their ability to participate any further in the research study. Therefore, there 
is a risk that the participant may endure psychological stress as a result of completion of this assessment. 
 
There is a rare risk that confidentiality of the subjects and/or their families may be broken. However, the study 
staff will be trained to minimize these risks to ensure confidentiality is not broken before, during and after data 
collection. 
 
 Risks to Non-Subjects 
The subject’s parent(s) will need to be engaged in the research study in order to ensure that the child is following 
the study protocol. Changes in behavior that may be attributed to study protocol procedures may be a 
psychological risk to non-subjects, as the study protocol may disrupt daily activities. Additionally, parents are 
expected and will be required to travel to the study center their child, and therefore, they may experience a travel 
inconvenience for their time. 
 
 Minimizing Risks 
In order to minimize risk, the research team will be composed of members who have sufficient expertise and 
experience to conduct the research. Actigraph and accelerometer data will be collected using standard 
procedures. The study staff will be trained in device placement to ensure that the participant is comfortable before 
leaving the sleep center. An unknown preexisting condition that is discovered at the research lab will prompt the 
study staff to explain to the participant that they need a clinical examination to determine their condition and that 
no medical diagnosis has been made. Additionally, study staff will have resources available to subjects in the event 
that they ask for further medical advising related to the condition. Data confidentiality will be protected by storing 
all data on a secure server recommended by Rutgers IT department on a password protected computer. All hard 
copies of participant data will be stored in a locked filing cabinet in a locked office space. 
 
 Certificate of Confidentiality (CoC) 
N/A (will not be obtained; not funded by NIH) 
 
 Potential Benefits to Subjects 
At the follow-up study visit, trained study staff will have the capacity to share individualized sleep reports with the 
study participants and their families. These sleep reports may be a valuable tool for participants to learn about 
their own sleep habits. Educational materials will also be distributed to the parents to help the adolescent improve 
sleep. Additionally, participants will be compensated according to study protocol adherence. Adherence will result 
in a maximum compensation of $70. 
 
 Provisions to Protect the Privacy Interests of Subjects 
The study coordinator will be responsible for coordinating all aspects of research that involve confidential 
information, including participant scheduling, orientation, participant call-ins and follow up visit to ensure subject 

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privacy is protected. Participants will be instructed to contact the study coordinator with any questions or 
concerns related to the study protocol, which will limit the number of investigators that may be aware of the 
participant’s and his/her parent’s identity. 
 
 Research Team Access to Subject Data 
The study coordinator and PI will have access to a password-protected folder on a shared drive which will contain 
the data collected from the study. 
 
4.8 Secondary Data 
N/A 
A. Chart/Record Review Selection 
N/A 
 
B. Secondary Specimen Collection 
N/A 
 
Specimen Storable Procedures 
N/A 
 
 
Specimen Data 
N/A 
 
5.0 Special Considerations 
 
 
5.1 Health Insurance Portability and Accountability Act (HIPAA) 
N/A 
 
5.2 Family Educational Rights and Privacy Act (FERPA) 
N/A 
 
5.3 NJ Access to Medical Research Act 
N/A 
5.4 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
A. “Special” Classes Of Subjects 
 Children in our study are defined as persons who have not attained the legal age for consent to procedures 
involved in the research. We plan to seek child assent, or a child’s affirmative agreement to participate in 
research. Permission will be obtained via parental consent to allow their child’s participation in the research. 
Parent is defined as a child’s biological or adoptive parent. The study coordinator, trained in informed consent 
procedures, will obtain written informed consent for the parent of the child and written assent from the child 
before proceeding with study. We anticipate that the study procedures will present no more than minimal risk 
to the subjects who participate in the research. 
 
6.0 Research Data Protection and Reporting 
 
 
6.1 Data Management and Confidentiality 
 
A. As this is a pilot study, primarily descriptive statistics will be conducted on sleep and physical activity data. No formal 
analyses will be conducted on feasibility/acceptability questionnaire and subsequent interview responses. Mixed-model 
ANOVAs will compare changes in sleep and physical activity between both groups. 

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B. All data will be de-identified (a subject id number will be assigned to each participant and used to track each data file) 
and will be stored on a password-protected shared drive folder (the study coordinator and PI will be the only two with 
access to this folder). 
 
C. All sleep and physical data will be separately independently by the study coordinator and PI to determine reliability in 
the application of scoring rules. Questionnaire data will be entered by two study staff members independently and then 
compared to ensure accuracy. 
 
D. Sleep and physical activity data will be obtained from an output that the device software provide. This data will be 
checked against sleep diary and call-in data and adjusted as necessary by trained study staff. Questionnaire, sleep diary, 
sleep device and physical activity device data will be aggregated and entered in to a database in SPSS. This file will be 
stored on a password-protected shared drive folder. The study coordinator and PI will have access to this folder. The 
study coordinator is primarily responsible for receipt of the data and the PI will ensure its storage. The data will be 
stored for five years. 
 
6.2 Data Security 
Any data collected in this study, including demographic/health information and experimental testing, is solely for research purposes 
and will be kept in locked file cabinets with restricted access. Only the PI, co-investigators, and approved research staff will be able to 
access the stored data. Interview data, test results, and other information collected from participants will be identified using 
participant ID numbers to de-identify their personal name from the files. Only the PI (Dr. Andrea Spaeth) and the study coordinator 
will have access to the file that associates participant ID numbers to identifying information. Data collected in this study will be stored 
in locked filing cabinets and/or on password-protected computers. All signed consent forms will be maintained in a file separate from 
the individual participant’s data. Five years following the completion of this study, the association between participant ID numbers 
and identifying information related to participants (e.g., names) will be destroyed. 
 
6.3 Data and Safety Monitoring 
The study protocol is not expected to cause more than minimal risk to participants. 
 
6.4 Reporting Results 
A. Sharing of Results with Subjects 
Data collected using the sleep wrist actigraph will be downloaded off of the device and presented in a visual graph to the 
participants at the follow-up visit. Trained study staff will show the participants their average amount of sleep recorded for 
each night they wore the actigraph device to sleep. 
 
B. Individual Results 
Participants will be asked to complete a sleep disorders questionnaire. In the event a participant achieves a score that 
excludes them from the study, we will provide the participant with a referral to the Robert Wood Johnson Sleep Clinic. 
 
C. Aggregate Results 
N/A (Aggregate results will only be shared internally to inform the future study.) 
 
D. Professional Reporting 
If data is reported to other researchers and the scientific community for input in planning the future study, all subject 
identifiable information will be removed from the data set. 
 
6.5 Data Sharing 
The investigators will be responsible for protecting the rights of subjects and the confidentiality of the data during data sharing. Prior 
to sharing, data will be redacted to strip all identifiers to minimize the right of unauthorized disclosure of personal identifiers. 
Datasets will be stripped of items that could identify individual participants, including name, address, telephone numbers, etc. 

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Additionally, all subjects will be informed about data sharing in during the informed consent process to ensure that subjects are 
informed about the data sharing process. 
 
7.0 Data and/or Specimen Banking 
 
 
A. Storage Methods 
N/A 
 
B. Storage Data 
N/A 
 
C. Releasing Data/Specimens 
N/A 
 
8.0 Other Approvals/Authorizations 
 
 
N/A 
 
9.0 Bibliography 
 
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States, 2015. Morbidity and mortality weekly report Surveillance summaries (Washington, DC : 2002). 2016;65(6):1-174. 
2. 
Zhang J, Paksarian D, Lamers F, Hickie IB, He J, Merikangas KR. Sleep Patterns and Mental Health Correlates in US 
Adolescents. The Journal of pediatrics. 2017;182:137-43. 
3. 
Lang C, Kalak N, Brand S, Holsboer-Trachsler E, Puhse U, Gerber M. The relationship between physical activity 
and sleep from mid adolescence to early adulthood. A systematic review of methodological approaches and meta- 
analysis. Sleep medicine reviews. 2016;28:32-45. 
4. 
Beebe DW, Simon S, Summer S, Hemmer S, Strotman D, Dolan LM. Dietary intake following experimentally 
restricted sleep in adolescents. Sleep. 2013;36(6):827-34. 
5. 
Klingenberg L, Chaput JP, Holmback U, Visby T, Jennum P, Nikolic M, et al. Acute Sleep Restriction Reduces 
Insulin Sensitivity in Adolescent Boys. Sleep. 2013;36(7):1085-90. 
6. 
Chan RS, Woo J. Prevention of overweight and obesity: how effective is the current public health approach. 
International journal of environmental research and public health. 2010;7(3):765-83. 
7. 
Werner H, Lebourgeois MK, Geiger A, Jenni OG. Assessment of chronotype in four- to eleven-year-old children: 
reliability and validity of the Children's Chronotype Questionnaire (CCTQ). Chronobiology international. 2009;26(5):992- 
1014. 
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Luginbuehl M B-KK, Ferron J, Anderson WM, Benbadis SR. Pediatric sleep disorders: Validation of the Sleep 
Disorders Inventory for Students. . School Psychol Rev. 2008;37(3):409-31. 
9. 
Terry PC, Lane AM. Apology. Development and validation of a mood measure for adolescents. Journal of sports 
sciences. 2002;20(4):365. 
10. 
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of health and social behavior. 
1983:385-96. 
11. 
Walach H, Buchheld N, Buttenmüller V, Kleinknecht N, Schmidt S. Measuring mindfulness—the Freiburg 
mindfulness inventory (FMI). Personality and individual differences. 2006;40(8):1543-55. 
12. 
Cognitive Tasks Joggle Research 2018 [Available from: https://admin.joggleresearch.com/Home/Tasks. 
13. 
Acebo C, Sadeh A, Seifer R, Tzischinsky O, Wolfson AR, Hafer A, et al. Estimating sleep patterns with activity 
monitoring in children and adolescents: how many nights are necessary for reliable measures? Sleep. 1999;22(1):95-103. 

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Sadeh A, Sharkey KM, Carskadon MA. Activity-based sleep-wake identification: an empirical test of 
methodological issues. Sleep. 1994;17(3):201-7. 
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Meltzer LJ, Walsh CM, Traylor J, Westin AM. Direct comparison of two new actigraphs and polysomnography in 
children and adolescents. Sleep. 2012;35(1):159-66. 
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Santos-Lozano A, Santin-Medeiros F, Cardon G, Torres-Luque G, Bailon R, Bergmeir C, et al. Actigraph GT3X: 
validation and determination of physical activity intensity cut points. International journal of sports medicine. 
2013;34(11):975-82. 
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Kuczmarski RJ, Ogden CL, Grummer-Strawn LM, Flegal KM, Guo SS, Wei R, et al. CDC growth charts: United 
States. Advance data. 2000(314):1-27. 
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Beebe DW, Zhou A, Rausch J, Noe O, Simon SL. The Impact of Early Bedtimes on Adolescent Caloric Intake Varies 
by Chronotype. The Journal of adolescent health : official publication of the Society for Adolescent Medicine. 
2015;57(1):120-2. 
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Arora T, Taheri S. Associations among late chronotype, body mass index and dietary behaviors in young 
adolescents. International journal of obesity (2005). 2015;39(1):39-44. 
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Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of Health and Social Behavior. 
1983;24(4):385-96. 
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Walach H, Buchheld N, Grossman P, Buttenmuller V, Kleinknecht N, Schmidt S. Measuring mindfulness in insight 
meditation (Vipassana) and meditation-based psychotherapy: The development of the Freiburg Mindfulness Inventory 
(FMI). Journal for Meditation and Meditation Research. 2001;1(1):11-34.