About the Study

What is HeLTI?

The Healthy Life Trajectories Initiative (HeLTI) was developed in partnership with research teams from Canada, India, China and South Africa and in collaboration with the World Health Organization to address the increasing rates of obesity, chronic diseases (such as heart disease diabetes), and mental illness around the world. Four separate studies are being conducted in Soweto (South Africa), Mysore (India), Shanghai (China), and the provinces of Ontario and Alberta (Canada) and all the studies are focused on improving the health and well-being of pregnancy-planning women and their partners from preconception (before conception) and into pregnancy and the postpartum period. This initiative will help us understand how to prevent children from later developing obesity and chronic diseases and it may improve the health of families in Canada and worldwide.

About HeLTI Canada

The purpose of HeLTI Canada is to evaluate whether technology-based care can improve the health of families before pregnancy (preconception), during pregnancy, and into early childhood, promote child development, and prevent the development of obesity and chronic diseases.

What will Happen in the HeLTI Canada Study?

If you agree to participate, we will follow you, your partner and first child (i.e. if you have a child up to 12 months of age at recruitment) from preconception (before conception) and into pregnancy and until the child born in the study is 5 years old.

HeLTI Canada is split into four phases:

  • Preconception (before pregnancy)
  • Pregnancy
  • Infancy [0-2 years]
  • Early childhood [3-5 years]

During these four phases we will collect from you: (a) questionnaire data (emailed online questionnaires) and (b) clinical data (e.g., weight, blood pressure). You may also be asked (c) to give a blood sample, which is completely voluntary. Women (and their partners) who do not get pregnant within the first 3 years of the study will finish the study at the end of the preconception phase (36 months after recruitment).

Purpose

To evaluate whether technology-based care can improve the health of families before pregnancy (preconception), during pregnancy, and into early childhood and promote child development while preventing obesity and chronic diseases.

Goal

To learn about how the health of parents and their behaviours before, during and after pregnancy can

  1. Promote child development
  2. Prevent obesity and chronic diseases such as heart disease and diabetes in children later in life
  3. Improve the overall health of families in Canada and worldwide.

Setting

The HeLTI Canada study started recruitment of 5300 families in January 2021 and will follow these families for 8 years. We are recruiting women and their partners who are planning to have a baby in the next 3 years and live in the provinces of Ontario (cities of Toronto, Ottawa, and Hamilton and the health regions of Durham, York, Peel, Halton, and Niagara) and Alberta (Edmonton, Red Deer, Calgary and surrounding area).

Benefits of Participating

You will not be paid for taking part in this study. However, you will be given a $15 gift card for each online questionnaire you complete as a token of appreciation for your time and commitment for enrolling in the study. You will also receive a $20 gift card per family for each clinic visit (for weight, blood pressure) and voluntary lab visit (for blood sample, if applicable) once recruited. A woman can earn up to $325 in gift cards plus $270 if her partner and first child also join and complete the study.

Locations

HeLTI Canada is being conducted in the provinces of Ontario and Alberta. In Ontario this includes the health regions of Toronto, Durham (e.g., Pickering, Oshawa, Ajax), York (e.g., Markham, Newmarket, Richmond Hill, Vaughan), Peel (e.g, Brampton, Caledon, Mississauga), Halton (e.g., Oakville, Burlington), Hamilton, Niagara (e.g., Niagara Falls, St. Catherine’s, Welland), and the Ottawa-area. In Alberta, this includes the Alberta Health Authority and the specific cities of Edmonton, Red Deer, and Calgary and the surrounding area.

Study Details

Included in the Healthy Life Trajectories Initiative (HeLTI), the HeLTI Canada study is part of an international collaboration between researchers in Canada, China, India, and South Africa, and the World Health Organization (WHO). The purpose of HeLTI Canada is to test whether technology-based care can improve the health of families before pregnancy (preconception), during pregnancy, and following delivery to early childhood. Parent’s health and behaviours (such as physical activity, nutrition, sleep patterns, social interactions, and others) before, during and after pregnancy, can affect children’s health and growth. This study will help us understand how to prevent children from later developing obesity and chronic diseases such as heart disease and diabetes and it may improve the health of families in Canada and worldwide.

We are recruiting families in Ontario (cities of Toronto, Ottawa, and Hamilton and the health regions of Durham, York, Peel, Halton, and Niagara) and Alberta (this includes the Alberta Health Authority and the specific cities of Edmonton, Red Deer, and Calgary and the surrounding area) who are planning a pregnancy in the next 3 years. If you agree to participate, we will follow you from preconception and through pregnancy and after delivery of the child conceived in this study until they are 5 years old. We also would like to invite (if applicable) your partner and your current child (up to 12 months old) to be part of the study, but their participation is completely optional.

HeLTI Canada is split into four phases:

  • Preconception,
  • Pregnancy,
  • Infancy [0-2 years], and
  • Early childhood [3-5 years].

During these four phases we will collect from you:

(1) questionnaire data (emailed online questionnaires) and

(2) clinical data (e.g., weight, blood pressure)*.

You may also be asked (3) to give a blood sample, which is completely voluntary (not required but optional). Women who do not get pregnant within the first 3 years of the trial will finish the study at the end of the preconception phase (36 months after recruitment).

At recruitment you will be asked to complete a detailed online questionnaire about your physical and mental health, lifestyle behaviours (e.g., nutrition, physical exercise, sleep), relationship with your partner (if applicable), socio-demographic status (e.g., age, education level), and medical history. This secure online questionnaire may take up to 60 minutes to complete depending on how you answer the questions. A private electronic link will be emailed to you which enables you to access the online questionnaire. If you have a partner, they will also be invited to participate in the study and complete a similar online questionnaire. If you are a mother and your child (up to 12 months old) is enrolled in the study, you will also be asked to complete an online questionnaire for your child. Follow-up online questionnaires later in the study will ask similar questions.

You will be asked to complete follow-up online questionnaires at 12, 24 and 36 months into the study (once per year), or until you become pregnant. Additional questionnaires will then be available between 24-28 weeks of pregnancy. After the baby is born and is 3, 6, 12, 24, 36, 48 and 60 months old, you will be asked questions about the baby’s health and development, your health behaviours, how you are feeling, your parenting experiences, and your relationship with your partner.

The HeLTI Canada study will also collect clinical health information (e.g., height, weight, blood pressure, waist circumference) about you, your partner (if applicable), and your child (if applicable). You can choose to immediately receive your health information, such as blood pressure, from the clinical research assistant. Health information will be collected from you and your partner and child (up to 12 months old) as part of recruitment and then when you (woman) becomes pregnant. We will then collect clinical data from you (woman) and your child born in the study at 24 months after delivery. At the end of the study at 60 months (when child born in the study is 5 years old), we will collect additional health information on you, your partner, and your children.

* Due to the COVID-19 pandemic the collection of clinical data is temporarily suspended. We will ask you questions about your height and weight during your online surveys. We expect to resume the clinical data measurement at some point during the trial, but we cannot anticipate when this will happen.

Approximately 1000 participants from the Toronto-area will be invited to have blood samples collected throughout the study. This is completely voluntary (not mandatory) and will require a quick visit to a professional LifeLabs location near you. If you are invited and willing (by accepting and signing the proper consent form for blood collection), blood samples will be collected from you, your partner and your child (the one born in the study). Maternal blood samples will be collected at recruitment, 24-28 weeks of pregnancy and at 60 months postpartum (at the end of the study when your child born in the study is age 5). The partner’s (paternal) blood samples will be collected at recruitment and at the end of the study. The child born in the study will have a blood sample taken at 24 months (2 years old) and at 60 months (5 years old).

Women and their partners will either be randomized to a 4-phase lifestyle behaviour intervention group and will work with a HeLTI Trial nurse OR to a control group who receives standard care and has access to various websites.

Randomization means that you are put into a study group by chance (like flipping a coin). There is no way to predict which group you will be assigned to. Neither you nor the study staff can choose what group you will be in. You will, however, be told which group you are randomized to.

 

 

You will not be paid for taking part in this study. However, you will be given a $15 gift card per participant for each online questionnaire you complete as a token of appreciation for your time and commitment for enrolling in the study. You will also receive a $20 gift card per family for each clinic visit (for weight, blood pressure) and voluntary lab visit (for blood sample, if applicable) once recruited. You could earn up to $325 in gift cards plus $270 if your partner and first child also join and complete the study.

There are several potential benefits of participating in HeLTI Canada. (1) You will have access to expert-selected health and parenting information and resources via the HeLTI Canada app and your personalized web-page. You may find this health information to be useful for you and your family. (2) You will also receive general feedback after you complete a study online questionnaire so you can track your health and health behaviours across time. (3) You will be providing valuable information that can be used to improve health services and the overall health of Canadian families. (4) Lastly, you will be contributing to a better understanding of healthy child growth and development and aid in the creation of new strategies to prevent obesity and chronic illnesses later in life. This study may inform future health policies that will have significant long-term impacts on global health. A summary of study findings will be available to you at the end of the project if you request it, even if you choose to leave the study.

If you decide to participate, every effort will be made to protect your privacy and the confidentiality of your data. Your study data will be coded (with a number) so that it does not contain your name, address or anything else that could identify you. Only the study researcher at St. Michael’s Hospital (Dr. Cindy-Lee Dennis) will be able to link your coded study data to you. No data relating to this study that includes your name will be released outside of the researcher’s office or published by the researchers.