Plain English Summary
Background and study aims
Mothers nutritional status influences the growth and development of infants during pregnancy and after birth, and growth and development at these stages in life will improve bone growth and influence risk of long-lasting conditions such as heart disease and obesity in adulthood. Studies have shown that women of childbearing age from disadvantaged backgrounds are more likely to have a poor diet, and that those with the least healthy diets were found to be less likely to follow a good infant feeding pattern. It is also found that one third of women have insufficient vitamin D in late pregnancy, which can affect their childrens fat and bone mineral content. This study aims to find out whether a behaviour change intervention given by nurses and aimed at improving lifestyle during pregnancy will help improve a vitamin D supplementation intervention and have a positive effect on maternal and infant health.
Who can participate?
Pregnant women who are 18 years and over will be eligible if they attend the participating hospital for nuchal translucency or dating scans between 9 and 17 weeks of pregnancy and are aiming to give birth at a local maternity hospital.
What does the study involve?
A research nurse will approach women at their screening or dating scan visits, screen them for eligibility and gain written informed consent. At their first visit at 14 weeks, body measurements and a blood sample will be taken and they will be chosen, at random, to receive either vitamin D tablets or placebo (dummy) tablets to be taken during the study. Neither they nor the nurse will know which they are taking. They may also be chosen, at random, to have additional support from the nurse to explore in a conversation how to have a healthy pregnancy, and to set some goals for health behaviour change. At 19 weeks women will have a routine NHS ultrasound scan and a research ultrasound scan. Those in the behaviour change group will be engaged in a second conversation and review of progress with their goals. At 26 weeks, a nurse will phone the women to check on the progress of the pregnancy and confirm the date of the next appointment. Those in the behaviour change group will be engaged in a third conversation and review of progress. At 34 weeks, women will have an extra 3D ultrasound scan, fill in a questionnaire and measurements taken at 14 weeks will be repeated. Those in the behaviour change group will be engaged in a fourth conversation and review of progress. At birth, when the women have had their babies, the midwife will collect samples from the placenta and the cord. Women will be invited to bring their babies for a bone scan and body measurements. A month after birth, a nurse will visit participants at home to discuss the health and well-being of the mother and their children. Those in the behaviour change condition will be engaged in a final conversation and review of goals. All mothers will be asked if they are prepared to be contacted again in the future to follow-up their babies as they grow.
What are the possible benefits and risks of participating?
Women will have 3D ultrasound scans of their babies, receive prints from the scan and an assessment of their baby's bone mass. These are not freely available to women under routine NHS care. Participants in the behaviour change group will be offered an opportunity to discuss issues arising with their pregnancy and skilled support in making changes to their lives and habits. This may lead to lasting improvements in their health and well-being, and in that of their child. The infant and childhood bone scan is associated with a low dose of radiation exposure, but this is equivalent to 2 days background radiation in Cornwall or 6 days in the UK generally. There is a possible and very small risk of asthma in children born to mothers in the top levels of vitamin D. The dose of vitamin D supplementation will bring women just into the normal range, to avoid over dosage. If the conversations cause distress, they will be stopped. All research staff are equipped with a list of helpline numbers so that participants can be referred to the appropriate service should it be necessary.
Where is the study run from?
Princess Anne Maternity Hospital, Southampton (UK)
When is the study starting and how long is it expected to run for?
October 2013 to December 2018
Who is funding the study?
The Medical Research Council, University Hospital Southampton NHS Foundation Trust, and NIHR Nutrition Biomedical Research Centre, Southampton (UK)
Who is the main contact?
Professor Cyrus Cooper
cc@mrc.soton.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Cyrus Cooper
ORCID ID
http://orcid.org/0000-0003-3510-0709
Contact details
MRC Lifecourse Epidemiology Unit.
University of Southampton
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
+44 (0)2380 777624
cc@mrc.soton.ac.uk
Additional identifiers
EudraCT number
2013-002854-66
ClinicalTrials.gov number
Protocol/serial number
452623v.1
Study information
Scientific title
Randomised controlled trial of an intervention to improve the diets, lifestyles and body composition of pregnant women and their offspring
Acronym
SPRING
Study hypothesis
Lifestyle support in pregnancy improves maternal vitamin D levels and body composition assessed by dual energy x-ray absorptiometry (DXA) at birth, in infants born to women who have been randomised to receive vitamin D supplements or placebo, and further randomised to receive behaviour change support in pregnancy by trained nurses or to receive usual care. It is an investigator-initiated translational study.
Ethics approval
Hampshire B, 12/09/2013, ref: 13/SC/0409
Study design
Phase II randomised controlled trial with process evaluation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Musculoskeletal
Intervention
Women attending the Princess Anne Hospital for dating scans will be recruited and randomised to receive vitamin D or a placebo, and further randomised to receive support from nurses trained in supporting women to change their health behaviours or to receive usual care. There will therefore be four groups of participants:
1. Vitamin D supplemented plus usual care
2. Placebo plus usual care
3. Vitamin D supplemented plus behaviour change support
4. Placebo plus behaviour change support.
Randomisation to vitamin D or placebo will be blinded. This is not possible for randomisation to the behaviour change condition. Women are likely, however, to be unaware of their intervention status. All women will have contact with the research team at four time points during pregnancy. Obstetric details will be recorded at birth, and mothers and babies will be visited one month post-natally. Vitamin D levels, body composition, lifestyle and psychosocial outcomes in women and children will be compared across the four groups.
Intervention type
Mixed
Phase
Drug names
Primary outcome measures
1. Vitamin D status of mother measured by assay at baseline and again at 34 weeks of pregnancy
2. Body composition of infants at birth measured by DXA scan
Secondary outcome measures
1. Maternal weight gain in pregnancy measured in kg at 14 and 34 weeks pregnancy
2. Rates of breastfeeding initiation and duration measured by questionnaire at 1 month after birth
3. Dietary quality of women measured by questionnaire and assay at 14 and 34 weeks of pregnancy
4. Self-efficacy measured by questionnaire at 14 and 34 weeks and 1 month after birth
Overall trial start date
01/10/2013
Overall trial end date
31/12/2019
Reason abandoned
Eligibility
Participant inclusion criteria
Women attending the Princess Anne Hospital for nuchal lucency or dating scans in early pregnancy
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
248
Participant exclusion criteria
1. Women under the age of 18
2. Living outside a Southampton postcode area
3. Multiple pregnancy
4. Severely unwell
5. Allergic to peanuts or soya
6. Involved in another research study
Recruitment start date
01/04/2014
Recruitment end date
31/12/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Southampton
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
University Hospital Southampton NHS Foundation Trust (UK)
Sponsor details
Research and Development
SGH - Level E
Laboratory and Pathology Block
SCBR - MP 138
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8120 8689
mikayala.king@uhs.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
Added 03/07/2014:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NIHR Nutrition Biomedical Research Centre, Southampton (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of the first paper in June 2017 which will cover aspect of the process evaluation. The study results are expected to be available in December 2019.
IPD Sharing plan:
Anonymised data will be made available on request and will be stored at the MRC Lifecourse Epidemiology Unit, University of Southampton.
Intention to publish date
31/12/2019
Participant level data
Available on request
Results - basic reporting
Publication summary
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27729061