Condition category
Pregnancy and Childbirth
Date applied
27/02/2016
Date assigned
04/03/2016
Last edited
29/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Daniel McCartney

ORCID ID

Contact details

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

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

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

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.
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.
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

Neonatal weight and health status

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

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

Sponsor information

Organisation

Dublin Institute of Technology (Ireland)

Sponsor details

The School of Biological Sciences
Dublin Institute of Technology
Kevin Street
Dublin
0000
Ireland

Sponsor type

University/education

Website

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

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes