Dr. Job Godino and associates are conducting a research study to assess the effectiveness of a weight control program in young adults. The purpose of this study is to determine the effectiveness of a technology, text messaging, social media, and health coaching intervention to improve weight over 24 months (96 weeks) among young adults in a university setting.

What will happen to you in this study and which procedures are standard of care and which are experimental?

If are eligible and agree to be in this study, the following will happen to you:

  1. You will be scheduled for an appointment at the Exercise & Physical Activity Resource Center (EPARC) at UCSD at the start of the study and every 6 months for 2 years (total of 5 measurement visits). At this appointment you will have your height, weight, blood pressure, heart rate and waist, arm and hip circumference measured by research staff, and undergo a body composition scan to evaluate your bone density, muscle mass and body fat. At the same visit you will be asked to complete questionnaires regarding your physical activity, dietary, sleep and other health behaviors as well as psychological measures. The first appointment will last approximately 3 hours. Each following appointments will last approximately 2 hours.
  2. During your first appointment, you will receive a Fitbit Charge 3 and Aria Scale to use during the study and will be required to download Fitbit’s smartphone application.

You will be assigned by chance to one of the following study groups. Your chance of being assigned to each group is 1 in 3. Neither you nor the researchers can choose the group to which you will be assigned.

  1. Treatment 1 group – If assigned to the treatment 1 group, you will receive a Fitbit Charge 3 and Aria scale, have access to the Fitbit smartphone application, receive daily text messages related to physical activity, diet, sleep, resilience, and weight loss/ maintenance, be required to follow SMART 2.0’s social media page on Facebook, be asked to follow SMART 2.0’s Instagram and/or Twitter page(s), be assigned to a private online group on Facebook messenger with 6-12 total participants and the SMART 2.0 health coaching team, and receive individual health coaching sessions with the SMART 2.0 health coaching team. Additionally, you will be asked to return for measurements every 6 months for the 24-month (96 week) study duration.
  2. Treatment 2 group – If assigned to the treatment 2 group, you will receive a Fitbit Charge 3 and Aria scale, have access to the Fitbit smartphone application, receive daily text messages related to physical activity, diet, sleep, resilience, and weight loss/ maintenance, be required to follow SMART 2.0’s social media page on Facebook, be asked to follow SMART 2.0’s Instagram and/or Twitter page(s), and be assigned to a private online group on Facebook messenger with 6-12 total participants and the SMART 2.0 health coaching team. Additionally, you will be asked to return for measurements every 6 months for the 24-month (96 week) study duration.
  3. Control group – If assigned to the control group, you will receive a Fitbit Charge 3 and Aria scale and have access to the Fitbit smartphone application. You will be asked to return for measurements every 6 months for the 24-month (96 week) study duration and will not receive any further communication or engagement from the study team.

What risks are associated with the study?

Participation in this study may involve some added risks or discomforts. These include the following:

  1. Anxiety or embarrassment when answering personal questions on lifestyle history and psychological factors during the measurement questionnaires. While we would like you to answer all questions, you have the right to skip any question you do not want to answer, or to stop participating at any time.
  2. Anxiety or embarrassment related to one’s personal exercise and nutrition practices and sharing this information with others via social media, health coaching, and Fitbit. While we encourage you to share your experiences, you have the right to only share what you feel comfortable, or can stop participating at any time.
  3. Feelings of inadequacy or embarrassment if unable to succeed at agreed upon diet, physical activity, sleep and/or weight goals. To minimize this risk, the SMART 2.0 team will provide a positive and supportive context.
  4. Concern for personal privacy to divulging personal information and security of providing personal information over the internet. The study’s Facebook, Instagram and Twitter pages will protect user data and honor privacy choices. We will ensure that you aware of Facebook, Instagram and Twitter privacy policies and how you can control and/or change their privacy settings by providing you with a handout prior to the start of their participation in the study on how to set their privacy preferences. The health coaching team will monitor the study’s Facebook, Instagram and Twitter social media pages and each Facebook Messenger group and alert you to any observed privacy risks.
  5. Injury and the rare occurrence of a cardiovascular event during physical activity. This will be minimized by providing you with lessons and instruction on how to reduce risk of injury and developing gradual stepped physical activity goals.
  6. Physical discomfort related to wearing the Fitbit device. Physical discomfort from wearing the devices will be minimized by providing instructions on how best to wear the Fitbit Charge HR and study staff will be present to make any necessary adjustments.

You will be assigned to a study group at random (by chance). Your assignment is based on chance rather than a medical decision made by the researchers. The study group you are assigned to might not be the group you would prefer to be in. Your assigned study group might also prove to be less effective or have more side effects than the other study groups(s), or other treatments available for your condition.

During your participation in this research study, you will be exposed to radiation from imaging scans on a machine called dual-energy x-ray absorptiometry (DEXA). You will undergo a scan at each of the measurement visits, for a total of 3 scans throughout the study. During your participation in this research study, you will be exposed to radiation from scheduled x-rays (DEXA scans). The total exposure resulting from these imaging studies is calculated to be approximately 0.20 mSv. This amount is less than you would receive from one year of natural exposure in the San Diego area, which is approximately 1.6 mSv. However, since the long-term effects of exposure to a fetus are not known, pregnant women will not be scanned. Cumulative exposure from radiation may increase your risk of developing certain types of cancer in the future.

Because this is a research study, there may be some unknown risks that are currently unforeseeable. You will be informed of any significant new findings.

What benefits can be reasonable expected?

There may or may not be any direct benefit to you from these procedures. The investigator(s), however, may learn more about ways in which to bring about healthier lifestyles and prevent weight gain through a technology and health coaching-based intervention, and you may benefit from a feeling of well-being through helping researchers in this process.

Can you choose to not participate or withdraw from the study without penalty or loss of benefits?

Participation in research is entirely voluntary. You may refuse to participate or withdraw at any time without penalty or loss of benefits to which you are entitled. If you decide that you no longer wish to continue in this study, you will be requested to notify the SMART 2.0 by emailing SMARTstudy@ucsd.edu or calling (858) 246-3302.

You will be told if any important new information is found during the course of this study that may affect your wanting to continue.

Can you be withdrawn from the study without your consent?

You may be withdrawn from the study for the following reasons:

  1. Develop a physical or mental health issue that prohibits compliance with the study’s prescribed dietary changes and/or moderate physical activity.
  2. Become pregnant.

You may also be withdrawn from the study if you do not follow the instructions given you by the study personnel.

Will you be compensated for participating in this study?

In compensation for your time and travel, you will receive a Fitbit Charge 3, Aria scale, and up to $100 for participating in this research. During the first measurement visit you will receive a Fitbit Charge 3 and Aria Scale as compensation. During the 6-month measurement visit you will receive $20 as compensation. During the 12-month and 18-month measurement visits you will receive $25 each as compensation. During the final 24-month measurement visit you will receive $30 as compensation.

If you are affiliated with SDSU or CSUSM, you will also receive an additional $15 at each measurement visit to offset additional travel costs.

Are there any costs associated with participating in this study?

There will be no cost to you for participating in this study.

What if you are injured as a direct result of being in this study?

If you are injured as a direct result of participation in this research, the University of California will provide any medical care you need to treat those injuries. The University will not provide any other form of compensation to you if you are injured. You may call the Human Research Protections Program Office at 858-246-HRPP (858-246-4777) for more information about this, to inquire about your rights as a research subject or to report research-related problems.

What about your confidentiality?

Research records will be kept confidential to the extent allowed by law. Confidentiality will be protected by:

  1. Assigning you an identification number that we will use instead of your name within all data collection procedures.
  2. Collecting data collected from SMART 2.0 social media pages in aggregate form where your name and username are removed and transferring it to secure, password-protected servers via a wireless internet connection.
  3. De-identifying all data that are securely downloaded during data collection procedures and through Fitbit and storing it on secure, password-protected servers.
  4. Keeping a master list of all participants and their written informed consent in separate locked file cabinets so that individuals are not easily connected to their electronic data or study results.

Research records may be reviewed by the UCSD Institutional Review Board.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

How will my study data be used in research and shared?

We will combine your de-identified study data with the de-identified study data of other participants. We will use this combined pool of data for our research. The results of our research will be made public via presentation(s) at scientific meetings or in scientific publications. Within 6 months after the completion of the study, or upon publication, whichever is first, the combined pool of data may be made available to the scientific research community via a public website and/or a data repository. When results are made public, your identity will not be shared. There will be no direct benefit to you from future use of your data because you will not be provided with any results or information regarding research done with your data.

If you are interested in participating in this study, please fill out the following screening questionnaire. A member of the SMART 2.0 will follow-up with you within one business days regarding your participation.

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