IRB NUMBER: 14-15344

IRB APPROVAL DATE: 05/27/2016

IRB EXPIRATION DATE: 01/06/2017

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

CONSENT TO PARTICIPATE IN A RESEARCH STUDY
Study Title: Moms Online Video Exercise (MOVE) Study
This is a research study that examines ways to help mothers exercise more in their daily lives.
The study researcher, Maya Mascarenhas, MPH from the UCSF Osher Center for Integrative
Medicine, will explain this study to you.
Research studies include only people who choose to take part. Please take your time to make
your decision about participating, and discuss your decision with your family or friends if you
wish. If you have any questions, you may ask the researchers.
You are being asked to take part in this study because you are a healthy mother who is interested
in using mobile apps and video technology to start exercising more.

Why is this study being done?

The purpose of this study is to learn more about how we can use online technology such as
mobile apps and video conferencing tools to increase activity levels in women with young
children.

Who pays for this study?

The National Institutes of Health (NIH) pays for the conduct of this study, including Dr.
Mascarenhas's salary.

How many people will take part in this study?

Approximately 150 women will take part in this study and each woman will be assigned to 1 of
30 exercise groups that will range in size from 2 to 12 women.

What will happen if I take part in this research study?

This study consists of the following: an introductory session, a trial period, baseline data
collection and surveys, participation in immediate or delayed exercise groups, end of study and
follow up surveys.
30 Minute Introductory Session:

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An introductory session will be set up at a time of your choosing. A consent form will be
emailed to you in advance.
During this introductory session, you will be walked through study details and any
questions or concerns will be addressed. If you wish to participate in the study, you will
be guided through the consent document. If you feel comfortable with joining the study,
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IRB NUMBER: 14-15344

IRB APPROVAL DATE: 05/27/2016
IRB EXPIRATION DATE: 01/06/2017

you will indicate your consent through an electronic signature and receive an electronic
copy of the consent form over email.
You will be asked questions about your exercise patterns and preferences during this call
and these responses will be recorded. The recordings will be confidential and will not
contain any identifying information.
You will be asked to pass along the advertisement, if you wish, to any friends who might
be interested in joining the study.
You will be sent links to baseline survey and tracking forms you will need for your trial
session.

45 Minute Baseline survey, video trial:

You will complete an online baseline survey, which will include measures on physical
activity and psychological measures. All responses to these surveys will be confidential
and data will be analyzed and presented in aggregate anonymous form.
You will complete a trial period in which you will sign into 1 video call with other moms
for between 15-30 minutes to get to know one another and talk about exercise. You will
need to enter tracking information in online forms that will be provided.

Randomization
After the steps above are complete, you will be eligible to join the study and be
randomized to one of two study arms.
Randomization means you will be randomly assigned to a treatment based on chance, like
a flip of a coin. Neither you nor the researcher chooses your assigned group. You will
have an equal chance of being in either group.
You either will be assigned to the video group sessions immediately after randomization
or be invited to join a video group in 8 weeks. You will be emailed your assignment
results.
If there are concerns about the study, you should speak with a member of the study team
before randomization. You should only complete this step if you are willing to complete
all interviews, surveys, and participate in the video sessions if you are assigned to them at
enrollment.
30 Minute Exercise Group Sessions for 8 Weeks:

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If randomized to the join the exercise groups at the beginning of the study, you will
participate in video exercise sessions using exercise mobile apps over the course of 8
weeks that each last up to 30 minutes. Sessions will be held five times a week and you
will be expected to attend as many as possible.
Study coordinators will guide you through developing an 8 week exercise plan using
exercise mobile apps based on your skill, preferences and schedule availability.
You will agree upon a system for reminders, e.g. emails, texts or phone calls after
missing up to two sessions.
Before each of your scheduled exercise sessions, you will receive a reminder with a link
to join the virtual exercise video conference call through the study website from the study
coordinators. The link will be personalized so we can track when you join sessions.
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IRB NUMBER: 14-15344

IRB APPROVAL DATE: 05/27/2016
IRB EXPIRATION DATE: 01/06/2017

Your video call will be joined by other participants assigned to your group. Group
members can see and interact with one another over the video call during the check in
and exercise components of the session.
Only other group members and study coordinators will be able to join your exercise
session.
Group exercise sessions will start with a brief check in by all participants.
You will then follow exercise routines according to the plan you created. The types
exercises might include:
o Yoga routines
o Interval exercises
o Dance routines
Your interactions with other participants during the exercise portion of the session will be
like those that occur at a gym where each person is following an individualized routine.
In some exercise sessions, participants will follow different types and levels of exercise
routines while in some sessions all participants will all follow the same type and level of
routine.
You will track your participation measured in minutes spent exercising during each
session and exercise type using online tracking forms that you and your coordinator can
access.
This information will be accessible to you online and will be kept confidential.
You will have the option of sharing group level tracking results with other participants
and you will be able to see the progress of participants who have agreed to share these
results in the form of an optional periodic newsletter that coordinators will send out.
Participants will be given the option of joining a private Facebook group where relevant
articles will be posted and participants can post any new mobile apps and interact with
each other without it showing up in their main public feed.
You will have the option to join in an email group with your group and study staff to
communicate if you are going to miss a session or want to reach out to other members.
You can join or leave this group at any time during the study.
The video exercise sessions will not be audio or video recorded.
Study coordinators will check in at the end of the first week and the end of the first month
to provide support and make adjustments to the schedule and plan as needed.

30 Minute End of Study - survey, tools for continuation:

At the end of 8 weeks, you will be sent an end of study survey.

You will need to schedule an exit interview with study coordinators
If you participated in the 8 weeks of exercise sessions, you will be given tools to continue
doing group sessions if you choose with minimal levels of support from study staff.
If you were randomized to join after 8 weeks, you will receive an invitation and technical
support to join a regular an existing exercise group if you wish.

30 Minute Follow Up at 12 weeks:

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You will be contacted to fill out a follow up survey.

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IRB NUMBER: 14-15344

IRB APPROVAL DATE: 05/27/2016
IRB EXPIRATION DATE: 01/06/2017

Study location:
All these procedures will be done wherever you feel most comfortable. They will require that
you use exercise in front of a video camera on your computer, phone or tablet and you can
decide what location works best for that purpose.

How long will I be in the study?

Participation in the study will take up to a total of up to 22 hours over a period of 8 weeks. The
follow up session at 12 weeks will take up to 30 minutes, for a total of 23 hours.

Can I stop being in the study?

Yes. You can decide to stop at any time. Just tell the study researcher or staff person right away
if you wish to stop being in the study.
Also, the study researcher may stop you from taking part in this study at any time if he or she
believes it is in your best interest, if you do not follow the study rules, or if the study is stopped.
If you choose to stop being in the study, researchers will send you a short survey to gather
information on why you stopped and how they can improve the study for future participants.
Responses will be kept confidential.

What side effects or risks can I expect from being in the study?
Heart: There is a minor risk of heart problems (arrhythmia, cardiac arrest, and heart attacks)
that can occur while exercising though they are more likely to happen in individuals who
dont exercise than those who do; and more likely to occur in individuals with existing heart
conditions.
Injuries: There is a risk of musculoskeletal injuries such as sprains when individuals become
physically active beyond their fitness levels. Participants will be instructed to start with low
intensity exercises and gradually build up the intensity of their exercise sessions.
Privacy Participation in research may involve a loss of privacy, but information about you
will be handled as confidentially as possible. We will take several measures to keep your
participation and all of the data we collect from you secure and anonymous.
Participants randomized to the intervention will be asked to take part in video group
exercise sessions and check ins. Your name, email address and any information you
share during check in could be shared outside the group by other participants;
however we will instruct all participants to keep any information shared confidential.
Participants will be given the option of sharing their adherence to the intervention
with other group members and have their groups aggregate data shared with other
groups. Other participants could share this information outside the group; however we
will instruct all participants to keep this information confidential.
We will also track adherence by counting the number of clicks on the link you use to
enter into video sessions. This information will not be shared.
Participants will be given the option of joining a Facebook group which is a public
site. However, the group created for this study will be a private group where
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IRB NUMBER: 14-15344

IRB APPROVAL DATE: 05/27/2016
IRB EXPIRATION DATE: 01/06/2017

participants can interact with other participants without their membership or

interactions showing up in their public feed
Participants will be asked to fill out surveys; data will be kept on a secure encrypted
server.
Participants will share information on their exercise patterns that will be recorded,
however no identifying information will be collected in this recording so that all
audio data will remain anonymous. All audio files will be labeled with study ids and
dates and once this information is transcribed, the audio files will be destroyed.
For more information about risks and side effects, ask one of the researchers.

Are there benefits to taking part in the study?

There is a wide range of benefits associated with exercising. Research shows that exercising
extends your life span, reduces your risk of many types of disease including heart disease,
diabetes, and breast cancer. People who are fit are also less likely to get injured in the future.
Exercising also increases well-being, reducing depression and anxiety and increasing self-esteem
and positive outlook.

What other choices do I have if I do not take part in this study?

You are free to choose not to participate in the study. If you decide not to take part in this study,
there will be no penalty to you. You will not lose any of your regular benefits, and you can still
get your care from our institution the way you usually do.

Will information about me be kept private?

We will do our best to make sure that the personal information gathered for this study is kept
private. However, we cannot guarantee total privacy. Your personal information may be given
out if required by law. If information from this study is published or presented at scientific
meetings, your name and other personal information will not be used.
Organizations that may look at and/or copy your research records for research, quality assurance,
and data analysis include:
UCSFs Committee on Human Research
The researchers will ask you and the other people in the group to use only first names during
the group check in and exercise sessions. They will also ask you not to tell anyone outside the
group what any particular person said in the group. However, the researchers cannot guarantee
that everyone will keep the discussions private.

What are the costs of taking part in this study?

You will not be charged for any of the study treatments or procedures.

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IRB NUMBER: 14-15344

IRB APPROVAL DATE: 05/27/2016
IRB EXPIRATION DATE: 01/06/2017

Will I be paid for taking part in this study?

You will not be paid for any of the study treatments or procedures. At the end of the 8 week
study period, we will enter all participants who complete the online survey and interview into a
drawing for a Fitbit device (estimated value of 100 dollars). The chance of winning is about 1 in
20.

What happens if I am injured because I took part in this study?

It is important that you tell your study researcher, Maya Mascarenhas, if you feel that you have
been injured because of taking part in this study. You can tell the researcher over email
ucsfmove@gmail.com or telephone 415-890-2878.
Treatment and Compensation for Injury: If you are injured as a result of being in this
study, the University of California will provide necessary medical treatment. The costs of
the treatment may be billed to you or your insurer just like any other medical costs, or
covered by the University of California, depending on a number of factors. The
University does not normally provide any other form of compensation for injury. For
further information about this, you may call the office of the Committee on Human
Research at 415- 476-1814.

What are my rights if I take part in this study?

Taking part in this study is your choice. You may choose either to take part or not to take part in
the study. If you decide to take part in this study, you may leave the study at any time. No matter
what decision you make, there will be no penalty to you in any way. You will not lose any of
your regular benefits, and you can still get your care from our institution the way you usually do.

Who can answer my questions about the study?

You can talk to the researcher about any questions, concerns, or complaints you have about this
study. You can contact the researcher Maya Mascarenhas over email ucsfmove@gmail.com or
telephone 415-890-2878.
If you wish to ask questions about the study or your rights as a research participant to someone
other than the researchers or if you wish to voice any problems or concerns you may have about
the study, please call the Office of the Committee on Human Research at 415-476-1814.

CONSENT
PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to be in
this study, or to withdraw from it at any point without penalty or loss of benefits to which you
are otherwise entitled.
If you wish to participate in this study, you should sign below.

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IRB NUMBER: 14-15344

IRB APPROVAL DATE: 05/27/2016
IRB EXPIRATION DATE: 01/06/2017

09/05.2016

Amalia Egri Freedman

Date

Participant's Signature for Consent

Date

Person Obtaining Consent

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