Plain English Summary
Background and study aims
Nutrition during pregnancy plays a key role in providing the best environment for the baby’s growth and development. If the baby is not provided with appropriate nutrition during pregnancy, they may be at increased risk of poor health later in life. This study aims to investigate if a web-based dietary intervention during pregnancy improves the health of the mother and the baby.
Who can participate?
Women aged over 18 who are in the first trimester of a single pregnancy.
What does the study involve?
Participants complete a number of questionnaires about their dietary, physical activity and lifestyle behaviours, and have their weight measured. They are then allocated at random to either the intervention group or the control group. The intervention group receive individualised dietary advice at regular intervals throughout the remainder of their pregnancy. This advice is delivered over the web. In addition, the intervention group receive information to promote positive behaviours such as exercise. Participants who are diagnosed with gestational diabetes are also provided with dietary and lifestyle advice in line with gestational diabetes guidelines. These participants’ blood glucose and serum lipid measurements are collected. The control group re-take the dietary questionnaire over the course of their pregnancy, but instead of the individualised dietary advice provided to the intervention group, they receive standard care.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The Coombe Women and Infants University Hospital (Ireland)
When is the study starting and how long is it expected to run for?
October 2015 to October 2017
Who is funding the study?
Dublin Institute of Technology (Ireland)
Who is the main contact?
Dr Daniel McCartney
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
OptiMUM Nutrition: a web-based dietary intervention in pregnancy to optimise neonatal outcomes
Acronym
OptiMUM
Study hypothesis
Current hypothesis as of 09/10/2017:
This study aims to establish whether access to a customised website providing evidence-based nutrition information from early pregnancy improves pregnancy outcomes.
Previous hypothesis:
This study aims to establish whether individualised online dietary advice to enhance maternal dietary intakes from early pregnancy yields improvements in neonatal health outcomes at birth.
Ethics approval
1. The Coombe Women and Infants University Hospital’s Research Ethics Committee, ref: Study No. 6 – 2015
2. The Dublin Institute of Technology’s Research Ethics Committee, ref: 15-45
Study design
Single-blinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pregnancy, gestational diabetes
Intervention
Current interventions as of 09/10/2017:
Participating mothers will be recruited using a convenience sampling method of a confirmed singleton pregnancy as per the inclusion criteria. Written consent will be obtained. Once recruited, women will complete a number of questionnaires to determine their current socio-economic status, attitudinal and psychometric parameters, and their dietary, physical activity and lifestyle behaviours. Women will also have their weight status measured at this point. Women will then be allocated at random to either the intervention group or the control group.
1. The intervention group will receive access to an evidence-based nutrition and lifestyle website in addition to standard care.
2. The control group will receive standard care alone.
Previous interventions:
Participating mothers will be recruited using a convenience sampling method in their first trimester of a confirmed singleton pregnancy as per the above inclusion criteria. Written consent will be obtained. Once recruited, women will complete a number of questionnaires to determine their current socio-economic status, attitudinal and psychometric parameters, and their dietary, physical activity and lifestyle behaviours. Women will also have their weight status measured at this point. Women will then be allocated at random to either the intervention group or the control group.
1. The intervention group will receive individualised dietary advice at regular intervals throughout the remainder of their pregnancy. This advice will be delivered over the web. In addition, the intervention group will receive information to promote positive lifestyle behaviours such as exercise. Consenting participants diagnosed with gestational diabetes will be sub-categorised within the intervention group and provided with dietary and lifestyle advice in line with gestational diabetes guidelines. These participants’ blood glucose and serum lipid measurements will be collected.
2. The control group will re-take the dietary questionnaire over the course of their pregnancy, but instead of the individualised dietary advice provided to the intervention group, they will receive standard care alone.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Current primary outcome measures as of 09/10/2017:
Birth weight, measured as part of standard antenatal and postnatal care
Previous primary outcome measures:
Neonatal weight and health status
Secondary outcome measures
Current secondary outcome measures as of 09/10/2017:
1. Maternal engagement with the website, measured using web-stat analytics from recruitment at baseline throughout the gestational period
2. Neonatal OFC, measured as part of standard antenatal and postnatal care
3. Maternal GDM diagnosis, measured as part of standard antenatal and postnatal care
4. Maternal mode of delivery, measured as part of standard antenatal and postnatal care
5. Neonatal mode of feeding, measured as part of standard antenatal and postnatal care
Previous secondary outcome measures:
1. Maternal weight
2. Maternal dietary intakes
3. Maternal dietary quality
4. Maternal blood glucose and serum lipids
5. Maternal dietary and lifestyle knowledge
6. Maternal psychometric measurements
Overall trial start date
01/01/2015
Overall trial end date
30/10/2017
Reason abandoned
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 09/10/2017:
1. Women with a singleton pregnancy
2. Aged over 18
3. Have internet access
4. Proficient English
5. <18 weeks gestation
Previous inclusion criteria:
1. Women with a singleton pregnancy
2. Aged over 18
3. Have internet access
4. Proficient English
5. In their first trimester of pregnancy
Participant type
Other
Age group
Adult
Gender
Female
Target number of participants
500
Participant exclusion criteria
Women who do not meet the inclusion criteria
Recruitment start date
01/10/2015
Recruitment end date
30/10/2017
Locations
Countries of recruitment
Ireland
Trial participating centre
The Coombe Women and Infants University Hospital
0000
Ireland
Funders
Funder type
University/education
Funder name
Dublin Institute of Technology (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
30/10/2017
Participant level data
Other
Results - basic reporting
Publication summary