Participation involves the following tests, procedures, and questionnaires over the course of 6 months. 

Before you begin the main part of the study…

Screening Interview: You will complete a brief screening interview on your medical history, stress level, and lifestyle to see if you meet the study guidelines.

Study Orientation Session: You will attend an orientation session (in person or by phone) to learn more about the study, go over the consent form, and have your questions about the study answered. 

Pre-Study Blood Draw: Before completing any parts of the main study, you will likely be asked to complete a “Pre-Study Blood Draw” at a nearby clinic. The research staff will help you to identify a location that is convenient for you. This visit will take about 10 minutes. The study physician will review your results to confirm that it is safe for you to participate in the exercise required for this study. If results indicate that you are ineligible, you will not be asked to continue on in the study. 

Baseline Questionnaire: If you are eligible for the study and consent to participate, you will be asked to complete a questionnaire about your thoughts, feelings, lifestyle, diet, and eating habits. Questionnaires will be completed by paper, or online. Some of the questions may cover sensitive topics. If you do not feel comfortable answering a question, you may skip over it. Completion time for the questionnaire is expected to be approximately 90 minutes. 

Ecological Week (Week 1): You will also likely be asked to complete an “Ecological Week” for 7-days. During the “Ecological Week”, you will be provided an activity monitoring device to wear for 7 consecutive days that will measure your movement all day long. Actigraphy monitors measure steps, distance, and calories burned. The device does not track your geographical location. You will be asked to complete brief questionnaires about your mood and lifestyle 6 times per day during the 7 days of the “Ecological Week”. A hyperlink to the surveys will be sent to you by text message or email. Each questionnaire is expected to take about 4 minutes; for a total of 24 minutes each day. There will be a total of 2 “Ecological Weeks” throughout the whole study; once at the beginning of the study before you are randomized into either the aerobic exercise or waitlist control group and once again at the end of the study.

Trial Stretching Period: If you are eligible to participate and feel that you can commit to a 6-month training intervention, you will then be asked to participate in a 1-week trial stretching period. This trial period is to establish whether you can comply with a physical activity regimen at the levels we need for the current study. During this period, you will be assigned a coach who will monitor your adherence to the stretching protocol by contacting you once a day via text messages or phone. The coach will be a trained research volunteer or staff member. A specialized stretching manual and video will be provided and explained to you by your coach, and you will be asked to stretch four times a week, for 20 minutes each time. If you do not meet the stretching period completion requirements, you will not be asked to continue on in the study.

During the main part of the study…

Baseline Assessment: If you do meet the stretching period requirements, and wish to continue in the study, you will be asked to attend a baseline assessment at the UCSF Clinical Research Center. The baseline assessment will take an average of 3 hours total and will take place in the morning. Breakfast will be provided during your visit. You will have the following screening exams and procedures at the initial assessment.

• Blood Pressure: Your arm blood pressure will be measured twice.
• Blood Draw (Venipuncture): You will be asked to give a fasting blood sample for laboratory tests including blood glucose level. You will be asked to not eat or drink anything (except water) after 10:00pm the night before you come in for the blood test. Approximately 7 tablespoons of blood will be drawn by inserting a needle into a vein in your arm. We will provide you a breakfast as soon as this is completed.
• Body Measurements and Body Composition: We will measure your height and weight (to calculate body mass index) and hip and waist measurements (to calculate indices of abdominal fat). Body fat and bone density may also be measured with a DEXA (DXA) Scan. A DEXA Scan is a type of x-ray used to measure bone strength. During this test, X-ray pictures of your body will measure how much fat and muscle are present. You will lie flat on a table and a machine will take pictures of different areas of the body. This test will last about 20 minutes.  
• Questionnaires:We will ask you to complete questionnaires about your thoughts, feelings, lifestyle, diet, and eating habits. Some of the questions may be sensitive. If you do not feel comfortable answering a question, you may skip over it. This will take approximately 15-20 minutes
• Maximal Exercise Test on a Treadmill: We will ask you to complete an exercise test, during which you will be asked to work as hard as you can. You will start out walking at a comfortable speed, then the difficulty is gradually increased by either increasing the speed and/or by increasing the grade (hill) on the treadmill. During the test, your heart rhythm (electrocardiogram) and blood pressure will be measured continuously, and electrodes will be placed at various locations on the front and back of your upper body.Your blood pressure and perceived effort will be monitored at various intervals, and you will be asked to push yourself to your physical limit. You will also breathe through a mouthpiece so that the air you exhale can be collected so we can measure the amount of oxygen your body is consuming. You will be asked to work hard; however, you will be allowed to discontinue the test if you experience discomfort or feel you cannot continue. On the morning of the testing, a trained exercise physiologist at the UCSF Clinical Research Center will take vital signs and have checklist to review to confirm testing is appropriate. The CRC Staff may reserve the right to cancel or abort a test should there be significant medical concerns. This test takes about 45 minutes.
• Sit to Stand Chair Rise: You will be asked to sit on a chair with your arms folded across your chest. We will time how quickly you are able to stand up and sit down 5 times, keeping your arms folded across your chest. This test takes about 1 minute.
• Six Minute Walk: You will be asked to try and cover as much ground as you can in 6 minutes, walking back and forth on one side of a hallway. You are allowed to slow down, stop, and to rest as necessary, but the timer does not stop. When the 6-minutes has expired, you will be instructed to “stop” walking. This test takes about 10 minutes.
• Gait Speed: You will be asked to walk 4 meters at your normal walking pace. We will measure the time that it takes you to cover 4 meters at that pace. This test takes about 1 minute.

Randomization: Following completion of the baseline assessment, you will randomly be assigned into one of two groups, Aerobic Training or Activity Maintenance (maintenance of typical activity for the following 6 months).  Randomization means that a computer will place you in one of the two groups. Each participant has an equal chance of being placed in either group, and neither you nor the research staff will have any influence on which group you are placed in. If you are placed in the Aerobic Training group, you will participate in 24 weeks of aerobic training. If you are in the Activity Maintenance group, we will ask that you wait 24 weeks and then you will earn an equivalent gym membership after your participation in the study is complete.

If you are randomized into the Aerobic Training Group…

Aerobic Training Group: For 24 weeks, you will be asked to arrive at the closest YMCA fitness center 3-5 times per week according to a self-determined schedule to reach 150 minutes of moderate activity per week. Moderate levels include activities such as brisk walking, swimming laps, using an elliptical machine at a similar pace as brisk walking, and so on. Gym memberships, a Pulsar Heart Rate (HR) Monitor, and an activity monitoring device will be provided upon randomization into the exercise group. A manual for all fitness devices will be provided and a study staff person will train you how to use the devices as well. If you choose, we can connect you with other participants in the study in your area to attend the fitness center together, however, this is not a requirement for participation in the study.

Initial visit with a fitness instructor: You will have an initial visit with a fitness instructor at the YMCA fitness center. During this meeting, s/he will provide a personalized framework for the activities which you will be asked to complete that will help you reach 150 minutes of moderate levels of activity per week. Each training day will include a 15-minute warm-up and cool down with 30-40 minutes of workout.

Heart Rate Goals: You will be provided with a specialized heart rate goal for your work out. You will be permitted to select from a series of aerobic activities and for the first four weeks, will train at 50-60% of maximum HR as established during you aerobic capacity test during your baseline assessment. In the fifth through eighth weeks, you will increase your intensity to 60-70% of maximum HR and in the remaining months of the study (weeks 9 – 24), you will train at 70% of maximum heart rate. 

Monitoring Participation and Coaching: Throughout the 6 months of the study, you will be asked to wear a small, lightweight activity monitoring device during your exercise sessions. The Actigraph can be placed easily around your waist with a belt provided by the study. You will also wear a heart rate monitor when engaged in your exercise sessions. Trained research coaches will contact you weekly to monitor your progress and discuss any barriers to performance.

Ecological Week (Week 24): At week 24 of the aerobic training intervention you will likely be asked to complete a second “Ecological Week” at home. You will wear your activity monitoring device for 7 consecutive days. During the 7 days, you will complete brief questionnaires about your mood and lifestyle 6 times per day. A hyperlink to the surveys will be sent to you by text message or email. Each questionnaire is expected to take about 4 minutes; for a total of 24 minutes each day.

If you are randomized into the Activity Maintenance Group…

Activity Maintenance Group (No Aerobic Training): If you are randomized into the Activity Maintenance group, you will not participate in the aerobic training intervention. You will be asked to maintain your normal level of activity over the 6-month period of the study. During the 6 months, a research assistant will contact you every month by email to complete a brief questionnaire about your stress and activity levels over the past month. Upon completion of the second in-person clinic visit at the UCSF Clinical Research Center, you will be provided a 6-month membership to a YMCA fitness center. This membership is paid for by the study. You have the option to be matched with a research study coach who can contact you each month to assist you in tracking your progress and setting exercise related goals. You will not be provided with nor asked to wear body monitoring devices during any exercise you do upon the completion of the study. 

Finally we will ask you to complete...

Ecological Week (Week 24): At week 24 of the aerobic training intervention you will likely be asked to complete a second “Ecological Week” at home. You will wear your activity monitoring device for 7 consecutive days. During the 7 days, you will complete brief questionnaires about your mood and lifestyle 6 times per day. A hyperlink to the surveys will be sent to you by text message or email. Each questionnaire is expected to take about 4 minutes; for a total of 24 minutes each day.

Finally we will ask you to…

6-Month Follow-Up Questionnaire: You will be asked to complete a questionnaire about your thoughts, feelings, lifestyle, diet, and eating habits over the past 6-months. Questionnaires will be completed by paper or completed online. Some of the questions may cover sensitive topics. If you do not feel comfortable answering a question, you may skip over it.

Pre-Visit Blood Draw: At the end of the 6-month period, you will likely be contacted to set up a Pre-visit blood draw at a nearby clinic. The research staff will help you identify a location that is convenient for you. This visit will take about 10 minutes. The study physician will review your results to confirm that it is safe for you to participate in the exercise required at the 6-month follow up assessment. 

6-Month Follow-Up Assessment: At the end of the 6-month period, you will be contacted to set up a follow-up assessment at the UCSF Clinical Research Center. The follow up assessment will include all of the same lab tasks and measurements as the initial assessment (blood pressure, body measurements, DEXA, fasting blood draw, maximal exercise on a treadmill, sit to stand chair rise test, six minute walk, gait speed, and questionnaires). All blood tests will be completed at the UCSF Clinical Research Center in the morning, typically between 8:00AM-10:00AM depending on your appointment time. Approximately 7 tablespoons of blood will be drawn.

Returning the Body Monitoring Devices: At your Follow-Up clinic assessment, you will be asked to return the body monitoring devices (Actigraph and heart rate monitor) that were provided to you at the beginning of the study. You will return them to the research study staff members present at your visit or we will provide you a paid postage envelope to mail the devices directly to the Principle Investigator, Dr. Eli Puterman.

Optional Blood Banking: In the future, there may be discoveries about other important things to measure in blood and DNA about other important things to measure in blood and DNA in relation to eating behaviors, obesity, stress, activity, metabolic health and aging, and other health related conditions. Therefore, we would like your permission to save some of your blood (for up to 10 years) and DNA (for up to 20 years) for future research. We would like to save your blood and DNA for this amount of time because we may be able to explore our research questions more efficiently as new technologies and methods are discovered. After this time, the samples will be destroyed. All samples will be coded by ID number only, not by names, and will be available only to our research team. The code linking IDs to names will be kept in a locked file cabinet. The samples will be stored in the laboratories of the investigators. There will be no charge, and you will not receive any payment or financial benefit from any findings. You will not be told the results of this extra research. Participation in this extra research is voluntary. If, in the future, you decide you do not want any of your extra blood to be saved and possibly used in future research, you can always contact the researchers and tell them to not use your sample. All information about you will be handled as confidentially as possible. Your name will not be used in any published reports from research performed using your specimen. Please let us know whether you are willing to allow this extra research by checking the appropriate box at the end of this form.

Provide two contacts: We will ask you to provide the names and contact information of two people in your life who we may contact if we lose touch with you during the time that you are in the study. By signing this consent form, you are providing permission for us to contact these people if we lose touch with you over the course of the study.