Maternal and child health during pregnancy Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Medically cleared pregnant women (i.e. based on health care provider (HCP) assessment) 2. Less than 20 weeks pregnant (gestation) 3. Carrying a singleton fetus 4. Age 18-40 years old 5. Pre-gravid BMI between 18.5-39.9 kg/m² 6. Having Wi-Fi access
Exclusion criteria
Exclusion criteria: 1. Consuming alcohol, tobacco or other drugs 2. Pre-pregnancy insulin-treated diabetes 3. Untreated thyroid disease 4. Hypertension requiring medication 5. Other medical conditions that may impact maternal or fetal weight 6. Serious fetal congenital anomalies 7. Contraindications to exercise during pregnancy (based on Mottola et al., 2018) 8. Planning to have the child adopted (as our team would be unable to measure infant outcomes) 9. Women who score > 13 on the Edinburgh Postnatal Depression Scale during the first assessment or who indicate that they are at risk of harming themselves (these women will be referred to a psychologist) 10. Unable to communicate in English or French
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gestational Weight Gain (GWG) calculated using body weight data collected by the ‘Body+’ scale connected to the study mobile application (SmartMoms Canada app) that each participant will receive. Participants will be required to measure their weight a minimum of once per week, but the SmartMoms app will collect weight records daily or as many times as the individual uses the scale. 2. Infant weight-for-length trajectory (self-reported) calculated as a numerical variable (weight-for-length z-score) from weights and lengths measured by the parent at four time points (at birth and 6 weeks, 6 months and 12 months postpartum) and collected using an online questionnaire 3. App adherence calculated from the rate of study completion (=75%), results of the participant satisfaction questionnaire (>2) at the third trimester of gestation, and app software metrics (e.g. number of logins, app use or ‘counts’ on specific pages (i.e., nutrition, exercise, frequency of use per trimester) over the complete period of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Demographic information collected using the Sociodemographic Online Questionnaire at baseline 2. Pregnancy-related complications assessed using an online questionnaire at 6 weeks postpartum 3. Physical activity assessed using the Godin Leisure-Time Exercise Questionnaire as a categorical variable ("active", "moderately active", "insufficiently active/sedentary") and numerical variable (score of the questionnaire) during the six (6) prenatal and postpartum assessments (trimesters 1, 2, and 3, and 6 weeks, 6 months and 12 months postpartum) 4. Physical activity assessed using steps recorded on the Fitbit fitness tracker, which is connected to the SmartMoms Canada app, throughout the trial period continuously as long as the participant wears their Fitbit. For study analysis, this variable will be analyzed during the six (6) prenatal and postpartum assessments 5. Hours of sleep recorded on the Fitbit fitness tracker, which is connected to the SmartMoms Canada app, throughout the trial period continuously as long as the participant wears their Fitbit. For study analysis, this variable will be analyzed during the six (6) prenatal and postpartum assessments. 6. Nutritional assessment using data collected by Fitbit app (participant-recorded nutritional information). For study analysis, this variable will be analyzed during the six (6) prenatal and postpartum assessments 7. Health-related quality of life assessed using the Medical Outcomes Study Short-form 36 Health Survey online questionnaire during the six (6) prenatal and postpartum assessments 8. Pre/postnatal depression assessed using the Edinburgh Postnatal Depression Scale (EDPS) online questionnaire and measured as categorical variables (depression not likely, depression possible, fairly high possibility of depression, probable depression) and numerical variable (score of the scale) during the six (6) pr | — |
Countries
Canada