Study Title: Paternal Influences on Children’s Weight Outcomes (aka GUTS Fathers & Families)
Principal Investigator (PI): Jorge Chavarro, MD, ScD
PI Contact Information: email@example.com; 617-432-4584
Study Contact Information: firstname.lastname@example.org; 617-525-2032
Version Date: May 18, 2021
A research study
GUTS Fathers & Families is a research study. It is a sub-study of the Growing Up Today Study (GUTS).
Purpose of the research
This study will examine the role of fathers’ parenting practices on children’s health-related behaviors (including their diet, physical activity, sleep, and media use) and growth (including height and weight). It will also examine factors influencing fathering and the role of co-parents.
Sponsor of the research
This research is supported by the National Institute of Child Health and Human Development, which is part of the National Institutes of Health.
How we gathered your name and contact information
You are invited to this sub-study because you are part of the Growing Up Today Study (GUTS) cohort.
We aim to recruit 1,000 fathers from the Growing Up Today Study (GUTS) cohort and their co-parents. Your participation in this sub-study will allow us to gain an understanding of how fathers influence their children’s health behaviors and growth.
What we will ask you to do
If you agree to be part of this sub-study, we will ask you to complete an online questionnaire once a year for up to four years. Each questionnaire will take about 30 minutes to complete. The questionnaires include questions about your health and health behaviors, parenting, your child’s health and behaviors, and your family’s demographic information.
We will also ask you to provide contact information for your child’s co-parent (if applicable). We define “co-parent” as a partner you live with and with whom you share parenting responsibilities. A co-parent can be any gender and can be a biological, step/social, or adoptive parent. We will not share any of your questionnaire responses with your co-parent.
After completing the questionnaire, you will be asked to provide information on your child’s height and weight from birth. You can do this by sharing the growth chart from your child’s online medical record. Alternatively, you will have the option to have your co-parent upload your child’s growth data if you do not have access to this information. This information will be kept completely confidential and will allow us to answer research questions on the role of fathers on their children’s growth and health.
Providing your co-parent’s contact information and your child’s growth records are voluntary. If you choose not to provide such information, it will not affect your participation in GUTS Fathers & Families or the main GUTS cohort.
Thank you gift
You will receive a $10 Amazon.com Gift Card to thank you for each yearly questionnaire you complete. Your co-parent will also receive a $10 Amazon.com Gift Card when they complete a questionnaire.
Confidentiality, data security, and risk of breach of confidentiality
The only foreseeable risk associated with this sub-study is the unlikely and minimal risk of a breach of confidentiality. We believe risks are minimal given the protections in place. These protections include maintaining data in a secure, password-protected computing system. Questionnaire responses are de-identified and stored separately from participants’ names and contact information. Access to the data is provided through a secure login and granted on an as-needed basis per the GUTS Principal Investigator. We have never experienced a breach of confidentiality.
Data sharing with other researchers
Your de-identified information may be used or shared with other researchers without your additional informed consent.
Use of your information
Your information will not be used in clinical care. Only the Principal Investigator and study staff members authorized by the Principal Investigator will see your information.
The only foreseeable risk associated with this sub-study is the unlikely and minimal risk of a breach of confidentiality. Protections are in place as described above. The study questionnaires ask about topics that may seem sensitive to you (e.g., income, education, your child’s weight and height). You may skip any question you do not wish to answer.
Taking part is voluntary
Taking part in this sub-study is voluntary, and you can decide not to participate at any time. You may skip any questions you do not wish to answer.
Declining to take part will not affect your status as a valued GUTS participant.
If you receive care at Mass General Brigham, deciding not to participate won’t affect medical care you receive at Mass General Brigham now or in the future, or any benefits you receive now or have a right to receive.
If you have questions
If you have any questions about this sub-study, please contact the study team at email@example.com or 617-525-2032. If you want to contact the Principal Investigator directly, you can contact Dr. Chavarro at firstname.lastname@example.org or 617-432-4584.
Institutional Review Board (IRB) contact information
If you’d like to speak to someone not involved in this research about your rights as a research subject, or any concerns or complaints you may have about the research, contact the Mass General Brigham IRB at 857-282-1900.
Privacy of Health Information
We are required by the Health Insurance Portability and Accountability Act (HIPAA) to protect the privacy of health information obtained for research. This is an abbreviated notice, and does not describe all details of this requirement. During this study, identifiable information about you or your health will be collected and shared with the researchers conducting the research. In general, under federal law, identifiable health information is private. However, there are exceptions to this rule. In some cases, others may see your identifiable health information for purposes of research oversight, quality control, public health and safety, or law enforcement. We share your health information only when we must, and we ask anyone who receives it from us to protect your privacy.