Snacktivity™ intervention to promote physical activity during pregnancy
| ISRCTN | ISRCTN60667435 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60667435 |
| IRAS number | 319236 |
| Secondary identifying numbers | CPMS 55513, IRAS 319236 |
- Submission date
- 25/04/2023
- Registration date
- 31/05/2023
- Last edited
- 21/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Many studies show that pregnant women do not achieve 150 minutes of moderate-intensity physical activity per week, which is the recommended guideline. To date, there is a large amount of research describing the benefits and barriers of physical activity during pregnancy, but very few studies have looked at how to best support pregnant women and their ability to reach and maintain their physical activity levels. Through participation in physical activity during pregnancy, women have decreased risk of complications such as high blood pressure, excessive protein in their urine, too much weight gain and gestational diabetes, as well as reduced anxiety and feelings of depression. To try and help women reduce their chances of pregnancy-related complications, we plan to conduct the SUNNY study which aims to test the feasibility and acceptability of an approach we have called Snacktivity™ during pregnancy. Snacktivity™ is based on the idea that small, frequent doses of physical activity throughout the day, called 'physical activity snacks', can help people accumulate at least 150 minutes of moderate-intensity physical activity per week.
Who can participate?
90 eligible pregnant women in the UK
What does the study involve?
Participants will be randomly allocated to receive either the Snacktivity™ intervention programme or a standard antenatal care programme. Participation in this study will take place from when women are around 10-16 weeks pregnant until they are 36 weeks pregnant. In addition to receiving standard antenatal care, participants in the Snacktivity™ intervention group will receive access to a mobile phone application called the SnackApp and a physical activity tracker (Fitbit watch), which will measure their physical activity snacks throughout the week.
What are the possible benefits and risks of participating?
It is hoped that the Snacktivity™ intervention will encourage pregnant women to be more physically active, which may help reduce pregnancy-related complications. The researchers do not expect any risks from taking part in this study.
Where is the study run from?
Loughborough University (UK)
When is the study starting and how long is it expected to run for?
June 2022 to June 2024
Who is funding the study?
National Institute for Health and Care Research (NIHR) via a Research Professorship to Professor Amanda Daley and Loughborough University (UK)
Who is the main contact?
Kayleigh Sharp, k.j.sharp@lboro.ac.uk (UK)
Contact information
Scientific
The Centre for Lifestyle Medicine and Behaviour
School of Sport, Exercise and Health Science
Loughborough University
Loughborough
LE11 3TU
United Kingdom
 ORCID ID |
0000-0002-6547-4771 |
|---|---|
| Phone | +44 (0)1509 226372 |
| k.j.sharp@lboro.ac.uk |
Principal Investigator
The Centre for Lifestyle Medicine and Behaviour
School of Sport, Exercise and Health Science
Loughborough University
Loughborough
LE11 3TU
United Kingdom
| ORCID ID |
0000-0002-4866-8726 |
|---|---|
| Phone | +44 (0)1509 226353 |
| a.daley@lboro.ac.uk |
Study information
| Study design | Randomized interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial to investigate the feasibility and acceptability of Snacktivity™ in pregnant women |
| Study acronym | SUNNY |
| Study objectives | The aim of the SUNNY study is to undertake a randomised feasibility trial, with nested qualitative interviews, to assess the feasibility and acceptability of the Snacktivity™ intervention during pregnancy. |
| Ethics approval(s) | Approved 19/07/2023, South Central - Hampshire B REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; 020 7104 8289 hampshireb.rec@hra.nhs.uk), ref: 23/SC/0159 |
| Health condition(s) or problem(s) studied | Reproductive health and childbirth |
| Intervention | 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™. For the intervention group, Snacktivity™ will be promoted with a physical activity tracker (Fitbit watch) and access to the SnackApp. Both resources will help participants monitor their physical activity, activity snacks, and steps each day. The researchers will measure physical activity at the start of the study and at 36 weeks gestation for both the intervention and control group; 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. Snacktivity™ is based on the idea that small, frequent doses of physical activity throughout the day, called 'physical activity snacks', can help people accumulate at least 150 minutes of moderate-intensity physical activity per week. These physical activity snacks should last between 2-5 minutes and can include activities such as rushing for a bus, getting off the bus a stop earlier and walking to the destination, walking over to a colleague instead of sending an email when at work, taking the stairs instead of the lift, and calf raises whilst brushing their teeth. The Snacktivity™ approach also aims to reduce the time people spend sitting as a result of moving more frequently throughout the day, which can also have important benefits for health, particularly during pregnancy. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 06/06/2022 |
| Completion date | 25/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 90; UK Sample Size: 90 |
| Key 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)) |
| Key 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) |
| Date of first enrolment | 21/07/2023 |
| Date of final enrolment | 21/01/2024 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
Hospital/treatment centre
C/o: Dr Maria Koufali
Research and Innovation
Loughborough
LE11 3TU
England
United Kingdom
| Phone | +44 (0)1509228693 |
|---|---|
| m.koufali@lboro.ac.uk | |
| Website | http://www.lboro.ac.uk/ |
"ROR" |
https://ror.org/04vg4w365 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 25/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | The anonymised data/results collected will be used in Kayleigh Sharp's Doctoral Thesis. The anonymised data/results collected may also be published in a high-impact peer-reviewed journal, conference papers, and the media promoting the results of the study. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository at the Loughborough University repository (https://repository.lboro.ac.uk/). |
Editorial Notes
21/07/2023: The following changes have been made:
1. The recruitment start date has been changed from 07/08/2023 to 21/07/2023.
2. The recruitment end date has been changed from 06/02/2024 to 21/01/2024.
3. The ethics approval has been updated.
17/07/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 24/07/2023 to 07/08/2023.
2. The recruitment end date was changed from 23/01/2024 to 06/02/2024.
15/06/2023: The following changes were made to the study record:
1. The recruitment start date was changed from 26/06/2023 to 24/07/2023.
2. The recruitment end date was changed from 25/12/2023 to 23/01/2024.
05/06/2023: Internal review.
25/04/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
