Study Title: Paternal Influences on Children’s Weight Outcomes (aka GUTS Fathers & Families)
Principal Investigator (PI): Jorge Chavarro, MD, ScD
PI Contact Information: firstname.lastname@example.org; 617-432-4584
Study Contact Information: email@example.com; 617-525-2032
Version Date: May 18, 2021
Purpose of the research
This study will examine the influence of fathers’ and their co-parents’ parenting practices on their children’s health-related behaviors (including their diet, physical activity, sleep, and media use) and growth (including height and weight).
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
We received your name and contact information from your co-parent who is participating in GUTS Fathers & Families.
We aim to recruit 1,000 fathers and their co-parents to participate in this study. Fathers are recruited from the Growing Up Today Study (GUTS) cohort. We define their “co-parent” as a partner who they live with and with whom they share parenting responsibilities. A co-parent can be any gender and can be a biological, step/social, or adoptive parent.
Your participation will allow us to gain an understanding of how fathers’ and their co-parents’ parenting practices influence their children’s health behaviors and growth.
What we will ask you to do
If you agree to be part of this study, we will ask you to complete a 20-minute online questionnaire. The questionnaire includes questions about your health and health behaviors, parenting, your child’s health and behaviors, and general information about your family.
You may be asked to complete additional questionnaires over the course of this study (one questionnaire a year for up to 4 years).
You may be asked to provide information on your child’s height and weight from birth by sharing the growth chart from your child’s online medical record. This is optional.
We will not share any of your questionnaire responses with your co-parent participating in this study.
Thank you gift
You will receive a $10 Amazon.com Gift Card to thank you for your time completing the 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 study is the unlikely and minimal risk of a breach of confidentiality. Protections are in place as described above. The study questionnaire asks questions about topics that may seem sensitive to you. You may skip any question you do not wish to answer.
Taking part is voluntary
Taking part in this study is voluntary, and you can decide not to participate at any time. You may skip any questions you do not wish to answer.
If you decide not to participate in this study, it will not affect your co-parent’s status as a participant in Fathers & Families or in the main GUTS cohort.
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 question
If you have any questions about this sub-study, please contact the study team at firstname.lastname@example.org or 617-525-2032. If you want to contact the Principal Investigator directly, you can contact Dr. Chavarro at email@example.com 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.