Reproductive health and childbirth Pregnancy and Childbirth
Conditions
Interventions
Participants will be randomised to receive either standard physical activity advice during pregnancy or encouragement to achieve the recommended physical activity levels for pregnancy via Snacktivity™
however, steps, light-to-vigorous physical activity, moderate-to-vigorous physical activity, and activity snacks will be monitored for the intervention group throughout the 24-week intervention period
Sponsors
Loughborough University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women > = 18 years between 10 and 16+0 weeks gestation 2. Singleton pregnancy confirmed at early foetal scan 3. Able to speak and read standard English 4. Able to provide informed written consent 5. Access to an email address 6. Access to a smartphone with Bluetooth capable of hosting mobile applications (Apple iOS 10.0+ and Android OS 4.0+) 7. Complete < = 150 minutes of physical activity per week pre-pregnancy (as measured by the Exercise vital signs (EVS))
Exclusion criteria
Exclusion criteria: 1. Post-natal or non-pregnant women 2. Pregnant women past 16 weeks gestation 3. Severe sickness (hyperemesis gravidarum) 4. Currently taking part in a different research study that involves physical activity or other lifestyle behaviours 5. BMI >50 kg/m2 6. Inability or unwillingness to provide consent 7. Women whose GPs feel it is inappropriate for them to take part 8. Cannot speak and read standard English 9. No access to an email address 10. No access to a smartphone with Bluetooth capability for hosting mobile applications (Apple iOS 10.0+ and Android OS 4.0+) 11. Complete > 150 minutes of physical activity per week pre-pregnancy (as measured by the EVS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of a subsequent phase III randomised controlled trial (RCT) according to pre-specified progression criteria will be assessed at the final follow-up. The researchers are primarily interested in whether: 1. The trial is appealing measured using the number/percentage of people randomised against the recruitment target of 90 participants 2. The Snacktivity™ intervention is acceptable through assessing Snacktivity™ adherence measured using a physical activity tracker (Fitbit watch) and SnackApp data 3. Participant attrition measured using loss to follow-up in [the study notes] The feasibility and acceptability will also be assessed with participant interviews (intervention group only) and healthcare practitioner interviews on the indicators after the final follow-up: 1. Intervention delivery 2. Participant satisfaction, enjoyment, and intervention acceptability 3. Intervention sustainability | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total physical activity (light-to-vigorous activity and steps per day) measured using a research-grade wrist-worn accelerometer at baseline and 36 weeks gestation 2. Moderate-to-vigorous physical activity measured using a research-grade wrist-worn accelerometer at baseline and 36 weeks gestation 3. Sedentary time measured using a research-grade wrist-worn accelerometer at baseline and 36 weeks gestation 4. Gestational weight gain measured at baseline and 36 weeks gestation 5. Depression measured using the Edinburgh Postnatal Depression Scale at baseline, 26- and 36 weeks gestation 6. Fatigue measured using the Multidimensional Assessment of Fatigue at baseline, 26- and 36 weeks gestation | — |
Countries
United Kingdom
Outcome results
None listed