OptiMUM Nutrition: a web-based dietary intervention in pregnancy to optimise neonatal outcomes

ISRCTN	ISRCTN49955056
DOI	https://doi.org/10.1186/ISRCTN49955056
Protocol serial number	N/A
Sponsor	Dublin Institute of Technology (Ireland)
Funder	Dublin Institute of Technology (Ireland)

Submission date: 27/02/2016
Registration date: 04/03/2016
Last edited: 18/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Daniel McCartney
Scientific

School of Biological Science
Dublin Institute of Technology
Kevin Street
Dublin
0000
Ireland

Study information

Primary study design	Interventional
Study design	Single-blinded randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	OptiMUM Nutrition: a web-based dietary intervention in pregnancy to optimise neonatal outcomes
Study acronym	OptiMUM
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/10/2017

Eligibility

Participant type(s)	Other
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	500
Key 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
Key exclusion criteria	Women who do not meet the inclusion criteria
Date of first enrolment	01/10/2015
Date of final enrolment	30/10/2017

Locations

Countries of recruitment

Ireland

Study participating centre

The Coombe Women and Infants University Hospital

0000
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/10/2017: Internal review.
09/10/2017: The hypothesis, interventions, primary/secondary outcome measures and inclusion criteria were updated.