Sleep Duration and Risk for Obesity in Mexican American Children
Phase: NA
Conditions: Sleep
Sponsor: University of California, San Francisco

Title: Sleep duration and risk for obesity in Mexican American children 
Number: NCT03947918 
Document date: June 3, 2019 
PI: Martinez, Suzanna M (1 K01 HL129087) 
Subject: Study protocol

AT-HOME 3-WEEK PROTOCOL 
STUDY OVERVIEW 
The Summertime: Kids in Motion study is a 3-week study of Mexican American children in the
San Francisco area. This study includes six home visits, with the intention of making this study
convenient for participants and increase study completion. The RA will make 2 home visits
(Monday, Friday) and 1 phone call (Saturday) in Week 1; 1 visit (Friday) and 1 phone call
(Saturday) in Week 2; and 1 phone call (Friday) and a final visit (Saturday) in Week 3. In Week
1, children will continue their normal activities. In Week 2, children will be randomized to follow a
short (restricted) sleep or long (healthy) sleep schedule. In Week 3, children will be asked to
follow the sleep schedule opposite from Week 2. Behavioral assessments over the three weeks
will include sleep duration for (Tuesday night-Friday night), physical activity and sedentary
behavior (Wednesday-Friday), and dietary intake (Thursday and Friday). A full description is
provided below.
STUDY PROCEDURES AND DATA COLLECTION 
Recruitment 
Recruitment is critical to the study. Participants will be recruited from the community, such as
community organizations, youth summer programs, churches, swat meets, parks, and UCSF
clinics. Community organizations may be best to recruit from during the week, whereas parks
and churches may be the best during the weekend.
When recruiting from any community organization, it will be important to contact them ahead of
time over the phone. When going out into to make the initial contact, always have your SFSU
student ID or UCSF badge with you and introduce yourself as a research assistant working Dr.
Suzanna Martinez, a researcher at the Univ. of California, San Francisco. You will then describe
the study—a study examining how circadian behaviors such as sleep is related to physical
activity and eating patterns—and that you are recruiting families with 8-10-year-old Mexican
American/Mexican children. Describe the study protocol in short, and that this is a 3-week study.
If the organization contact is willing to allow you to recruit participants from that location, then
ask when would be the best time to catch parents so that you can speak with them and provide
them with study information to participate.
Once you have established the best time to recruit parents, at either community organizations or
parks, etc., return at those times to approach parents and give them background on the study.
Let them know that you are a student conducting research with Dr. Suzanna Martinez at the
University of California, Nutrition Policy Institute. We are conducting a study to understand more
about sleep and how it is related to children’s health. If parent(s) are interested, provide them
with more information about the study – that you are recruiting 8-10 year olds and their mother
to participate in a 3-week study. There are a total of 4 home visits and 3 phone calls. On the first
visit, mothers will be asked to complete a survey and you will measure the child and mom’s
height and weight. The rest of the home visits and phone calls will be made to ask children
about the foods that they eat. Though out the 3-week period, children will be asked to wear a
small monitor. One week they will sleep normal, one week they will sleep less, and one week
they will sleep more.

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If mother/parent is interested, then proceed with the screener [see Study Screener]. If it is 
confirmed that the family is eligible, then ask them if they would like to schedule their first visit 
for the upcoming Monday. If Monday is a bad day, then ask if Sunday or Tuesday would be 
better. If the parent seems disinterested, if it’s ok with them, let them know that they can always 
think about it and that you can contact them at another time. Try not to let the parent refuse. 
Once they refuse, they are no longer eligible to participate. Ask them if it would be better to call 
them at a later date. If they agree, then document their name and number.  
In the case that the parent is in a rush and needs to call you, or if they saw the information on 
the flyer and called the number, you will return their calls. [See Recruitment Phone Script for 
more information.]  
If parent agrees to a home visit, schedule the date and get their contact information. The day 
before the scheduled meeting, you will want to call the parent to remind them of the visit and to 
make sure that both mom and child are present for the visit. Also, let them know that you will be 
doing measuring height and weight so that they may want to dress in light clothing/to avoid 
heavy clothing. 
Week 1 
Monday (First home visit) 
Consent. Upon arriving to their house, introduce yourself as a research assistant(s) working with 
Dr. Suzanna Martinez at the University of California, Nutrition Policy Institute. Wait until the 
parent invites you in and once you are situated, you can proceed with the participant consent. 
During this process, you will hand the mother a consent form and let her know what information 
the document contains. Ask her whether she would like to have it read to her or whether she 
prefers to read it on her own. If she rather read it on her own, then you can use this time set up 
the research equipment (scale, stadiometer and computer). Once she has read the form, review 
the form and the study details with both mother and child. Note that they will be given an 
incentive for their time and participation. Ask if there are any questions. Once their questions 
are answered, both mother and child will sign the document. You will also provide them with a 
copy of the consent form. Make sure to keep the signed form.  
After consent. The RA will administer the online Qualtrics survey to the mother using the laptop 
computer. Individual interviews will last approximately 90 minutes, and will be conducted in the 
participant’s preferred language (Spanish/English). Ask whether the mother prefers to complete 
the survey on her own on the computer or if she would like you to administer the survey. You 
can also allow the mother to review the questions on her own if she prefers. Remind her that 
you will be there to assist her with any questions during this process. If they ask questions about 
which is the best answer, let them know there is no right or wrong answer. Choose the best 
answer that is true for her and the child being studied.  
After completing the survey, you will then explain that you’ll be measuring height, weight and 
waist for mother and child. If the mother wishes to answer the survey on their own, you can use 
this time to measure the child. Either way, you will start by measuring the child first and then go 
on to the mother. [See Anthropometry Protocol.] Then, the RA will provide the accelerometer to 
the child, and will verbally explain and demonstrate how to wear the monitor to both mother and 
child [see Activity Monitor Protocol]; written directions will be left with the mother and child 
[Activity Monitor Instructions]. The child will be asked to wear the monitor for 4 consecutive days 

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each week (starting on Tuesday and ending on Saturday at noon), except when bathing or 
swimming. On Wednesday - Friday, children and mothers will be asked to complete a sleep and 
food diary for the child and to document times that the accelerometer is removed. Mother and 
child will be given a food reference guide (with illustrations of serving sizes of different foods) to 
assist them when completing the diary. A pen and accelerometer will be provided in a small box, 
and the diary, food guide, and accelerometer directions in a folder. Let them know that you will 
be contacting them through the week to remind them to wear the accelerometer and fill out 
diaries. Ask whether they prefer texts or phone calls and confirm the best number to be reached 
at. Lastly, ask them the best time to stop by on Friday for the next visit. 
Texts and phone calls. Wednesday through Friday, mothers (and children if applicable) will 
receive two daily text messages (morning and evening) to remind children to wear the 
accelerometers and to complete the diaries.  
Friday (Second home visit) 
Upon arriving, greet the family and wait to be invited in. Make sure that the child has all the 
items such as the diary and food guide. First, you will have him/her remove the accelerometer 
and you will download the accelerometer data. Check to see that the child was compliant and 
that the accelerometer has 50% charge left. If child is missing one day, then ask him/her to keep 
the accelerometer until Sunday at noon. If they did not comply the whole week then ask them to 
repeat the week. If they do not want to repeat the week, then ask if they can re-wear it the 
following week. If they decide to withdraw, then thank them for their time as their participation is 
voluntary. Let them know that if they change their mind, they should call the number on the 
consent form.  
After downloading data, each participant will be visited to complete a 24-hour dietary recall 
about Thursday, which will be conducted for Thursday using the Nutrition Data System for 
Research (NDS-R; Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN). 
The child will be asked to use their diary and food guide to help facilitate the recall; the RA will 
go through the diary and recall with the child. [See 24-hr Diet Recall Protocol]. During this visit, 
you will have the opportunity to show the child how to use the food guide. Also, you will help 
mothers select a bedtime and wakeup time for the following weeks. Write this down on the front 
page of the Sleep and Food Diary, and on the Telephone/Texting Contact Form. At the end of 
the visit, families will be given a $25 gift card in appreciation of their time and participation. 
Before leaving, ask when would be a good time to call on Saturday. 
Saturday (Phone call) 
The RA will call the child on Saturday to complete a 24-hour dietary recall about Friday. Follow 
the same protocol as on Friday. After this you can remind the child that he/she is free to remove 
the accelerometer until Tuesday (unless they are being asked to re-wear), and that you will be 
making a reminder phone call on Tuesday.  
Week 2 
Children will be randomized into one of two sleep conditions: long (healthy) sleep or short 
(restricted) sleep. Participants have already been pre-assigned an ID number and random 
assignment has been predetermined in order to have an equal number of boys and girls in each 
condition. [See Participant Randomized Sleep Schedule.]  On Tuesday mid-morning, mothers 

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will be called to notify them regarding which sleep schedule their child will follow in Week 2. You 
will remind parents of the set bedtime and waking time for both conditions to make sure that 
their child complies with the sleep schedule. This information should be written on the front page 
of the Sleep and Food Diary, and on the Telephone/Texting Contact Form. Children will follow 
the sleep schedule from Tuesday to Friday night (ending on Saturday).  
For the long sleep condition, children will be asked to sleep ≥10.5 hrs.   
For the short sleep condition, children will be asked to sleep <8 hrs. If parents are concerned 
regarding this sleep schedule, you should acknowledge their concern. Remind them that this 
was discussed in the study consent form, and that you will be monitoring their child for daytime 
drowsiness, which is a possible side effect. It is ok for their child to nap. Also, reassure them 
that you will be monitoring their child and calling them to make sure that they are not 
experiencing too much daytime drowsiness. 
Child-mother pairs will continue to receive 2 daily texts or phone calls (Wednesday-Friday) as a 
reminder to wear the accelerometer, to complete sleep and food diaries, and to remind them of 
their bedtime and wake up time (as discussed).  
Children in the Short Sleep Condition will be called and asked to complete the Pediatric Daytime 
Drowsiness Scale (Thursday). You will calculate their drowsiness score and discuss with Dr. 
Martinez if the score is 13 or higher. The parent will also be advised. Encourage their child to 
take naps and that this part of the study is almost complete. If they wish to withdraw from the 
study, then that is ok, as their participation is voluntary.  
Friday (Third home visit)  
Children will be visited on Friday. Make sure that the child has the diary and food guide. Have 
him/her remove the accelerometer and download the accelerometer data. Check for compliance 
and accelerometer charge. If child is missing one day, then ask him/her to keep the 
accelerometer on until Sunday at noon. If they did not comply the whole week then ask them to 
repeat the week. If they do not want to re-wear and decide to withdraw, then thank them for their 
time.   
After checking accelerometer compliance, you will perform a 24-hour dietary recall about 
Thursday. Once again, you will use the diary and the food guide. Upon completion of the visit, 
the family will be given a $25 gift card for their time and participation in Week 2. Before leaving, 
ask when would be a good time to call on Saturday. 
Saturday (Phone call) 
Child participant will receive a phone call on Saturday and asked to complete a 24-hour dietary 
recall about Friday. Follow the same protocol as on Friday, using the diary and food guide. After 
this you can remind the child that he/she is free to remove the accelerometer until Tuesday 
(unless they are being asked to re-wear), and that you will be making a phone call on Tuesday 
as a reminder.  
A 3-night period between sleep conditions will follow. 
 
 

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Week 3 
During Week 3, participants will cross over to the opposite sleep condition.  Each child will 
follow the opposite sleep schedule from Week 2. This means that if they were in the short sleep 
condition in Week 2, then they will follow the long sleep condition in Week 3. You will remind 
mothers about bedtime and wakeup time to make sure that their child complies with the sleep 
schedule. This information should be written on the front page of the Sleep and Food Diary, and 
on the Telephone/Texting Contact Form. On Tuesday mid-morning, mothers will be called to 
notify them about which sleep schedule their child will follow in Week 3. 
Child-mother pairs will continue to receive 2 daily texts or phone calls (Wednesday-Friday) as a 
reminder to wear the accelerometer, to complete sleep and food diaries, and to remind them of 
their bedtime and wake up time (as discussed).  
Short Sleep Condition: You will call children in the short sleep condition to administer the 
Daytime Drowsiness Scale. Calculate their score, and follow the same procedure as Week 2. 
Follow same protocol as in Week 2. Remind the mother that this is the last week of the study 
and that their participation is almost complete. If the parent asks to withdraw from the study, 
then that is ok, as their participation is voluntary. 
Friday (Phone call) 
On Friday, children will receive a phone call and will be asked to complete a 24-hr dietary recall 
for Thursday. Follow procedures as in prior the weeks using diary and food guide. 
Saturday (Last home visit) 
The last visit will occur on Saturday, at which time the accelerometer data will be uploaded and 
the child will complete a final 24-hr dietary recall for Friday. All families will complete an exit 
interview to discuss challenges and positive aspects to participating in the study, ideas to 
facilitate participation, and barriers to and facilitators of longer sleep duration. [See Exit Survey.] 
Upon completion, families will receive a $40 gift card.