Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/04/2019
Date assigned
15/05/2019
Last edited
17/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Our aim is to evaluate the effects of a Mediterranean diet, in preventing the development of type 2 diabetes after giving birth, in women with gestational diabetes (GDM). Gestational diabetes is high blood sugar that develops during pregnancy. Before we run a large-scale trial to answer this question, we plan to test the feasibility of running the Mediterranean diet intervention in an NHS setting. Additionally, we will look at the acceptability of the study and interventions, particularly in the postnatal period, to women and healthcare professionals.

Who can participate?
Women above the age of 16 who have been diagnosed with gestational diabetes and are taking insulin or metformin during pregnancy are eligible to participate. As the diet intervention involves the intake of nuts, participants must not have nut allergies.

What does the study involve?
Participants will be asked to give consent to join the study during pregnancy, shortly before they are due to give birth. They will begin the diet intervention at 6-13 weeks after childbirth, and continue on the intervention until 1 year after childbirth.

Participants will be invited to attend 3 visits – at 6-13 weeks, 6 months and 1 year after childbirth. The intervention will be explained and started at 6-13 weeks post birth, and will consist of dietary advice and how to follow a Mediterranean diet (reduced red meat and processed sugar, increased fruit and vegetables, oily fish, olive oil and nuts).

We will provide nuts and olive oil, which are part of the intervention, for the duration of their trial participation. During their participation, women will receive regular support and advice from a trained health coach, both face-to-face and via a mobile app to discuss their progress with their diet goals. They can also use the app to interact with other women in the trial through a discussion forum.

Participants will be asked to attend the 3 hospital visits to assess their dietary habits, adverse events and check for type 2 diabetes. There will also be a qualitative part of the study, where acceptability of the study, views of the diet intervention and potential barriers to participation will be explored through interviews with a proportion of participants.

What are the possible benefits and risks of participating?
The anticipated benefit, which can only be confirmed with a subsequent full-scale trial, is that adherence to a Mediterranean diet will reduce the risk of progression to type 2 diabetes in women with previous gestational diabetes if applied in the immediate postnatal period.

There are no foreseen risks to participants through participation in this feasibility study. Women with nut allergies will be excluded from the study. The potential additional financial burden associated with Mediterranean diet ingredients will be avoided as olive oil and nuts will be provided to participants free of charge. There is one additional hospital visit (at 6 months) compared to routine follow-up pathways of women with gestational diabetes.

Where is the study run from?
The study will be organised and conducted at Barts Research Centre for Women’s Health (BARC), Queen Mary University of London. Participants will be recruited from maternity units within Barts Health NHS Trust, London.

When is the study starting and how long is it expected to run for?
The study is scheduled to start in May 2019, and is expected to run for 18 months, until November 2020.

Who is funding the study?
The main funder is the Barts and the London Charity. The study receives additional support in the form of dietary supplies free of charge or at a discount from the California Walnut Commission and KTC (Edibles) Limited.

Who is the main contact?
1. Dr Zoe Drymoussi,
z.drymoussi@qmul.ac.uk
2. Prof Shakila Thangaratinam,
s.thangaratinam@qmul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Zoe Drymoussi

ORCID ID

Contact details

Yvonne Carter Building
58 Turner Street
London
E1 2AB
United Kingdom
02078826692
z.drymoussi@qmul.ac.uk

Type

Scientific

Additional contact

Ms Shakila Thangaratinam

ORCID ID

http://orcid.org/0000-0002-4254-460X

Contact details

BARC (Barts Research Centre for Women’s Health)
Women’s Health Research Unit
58 Turner Street
London
E1 2AB
United Kingdom
0788 777 5891
s.thangaratinam@qmul.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

41072

Study information

Scientific title

Prevention of progression to type 2 diabetes in women with gestational diabetes: A feasibility study for a randomised trial on a Mediterranean diet

Acronym

MERIT

Study hypothesis

To evaluate the feasibility of introducing a simple, targeted dietary intervention with a Mediterranean based diet, to prevent the progression to Type 2 Diabetes after childbirth, in women with Gestational Diabetes

Ethics approval

Approval pending South Central - Berkshire Research Ethics Committee (Bristol REC Centre, Whitefriars, Level 3, Block B, Lewins Mead, Bristol, BS1 2NT; (020) 71048043; nrescommittee.southcentral-berkshire@nhs.net), ref: 19/SC/0064

Study design

Interventional non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Gestational diabetes

Intervention

Participants will be asked to give consent to join the study during pregnancy, shortly before they are due to give birth. They will begin the diet intervention at 6-13 weeks after childbirth, and continue on the intervention until 1 year after childbirth.

Participants will be invited to attend 3 visits – at 6-13 weeks, 6 months and 1 year after childbirth. The intervention will be explained and started at 6-13 weeks post birth, and will consist of dietary advice and how to follow a Mediterranean diet (reduced red meat and processed sugar, increased fruit and vegetables, oily fish, olive oil and nuts).

We will provide nuts and olive oil, which are part of the intervention, for the duration of their trial participation. During their participation, women will receive regular support and advice from a trained health coach, both face-to-face and via a mobile app to discuss their progress with their diet goals. They can also use the app to interact with other women in the trial through a discussion forum.

Participants will be asked to attend the 3 hospital visits to assess their dietary habits, adverse events and check for type 2 diabetes. There will also be a qualitative part of the study, where acceptability of the study, views of the diet intervention and potential barriers to participation will be explored through interviews with a proportion of participants.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Proportion of screened women who are eligible for participation
2. Proportion of eligible women who consent to participate in the study, and who commence the intervention at 6-13 weeks.
3. Rates of follow-up at 6 months and 1 year after delivery.
4. Proportion of recruited women who adhere to the intervention of a Mediterranean based diet. Adherence will be measured as:
4.1 Proportion of women who engage with the coach (in an intervention session, and/or through interaction with the App) – measured continuously from 6-13 weeks postnatally to 12 months postnatally
4.2 Proportion of women who consume nuts and olive oil as self-reported (daily through the App)
4.3 Mediterranean diet adherence as self-reported through the ESTEEM diet questionnaire at 6 months and 12 months postnatally

Secondary outcome measures

1. Proportion of women who engage with the lifestyle App, and frequency of engagement (on the App, engagement is defined as interaction e.g. logging a goal or sending a message), assessed continuously from 6-13 weeks postnatally to 12 months postnatally.
2. Women’s views relating to factors influencing their initial participation, the acceptability and adherence to the intervention, and the interaction with the App, through interviews 2-3 months and 5-8 months after the start of the intervention.
3. Robustness of the trial processes (measured as frequency of protocol deviations, data queries, issues with nuts and oil supplies, and major monitoring findings), assessed continuously throughout the trial.
4. Healthcare professionals’ views of the acceptability of delivering the intervention and adhering with the study protocol, through interviews during the intervention phase of the trial.
5. Proportion of women with normoglycaemia, and dysglycaemia (impaired glucose tolerance, pre-diabetes, T2D) through blood tests at 6 months and 12 months after delivery.
6. Weight change at 6 months and 1 year after delivery.
7. Preliminary relevant cost data to inform future economic evaluation, through clinical data collection at 6 months and 12 months postnatally.

Overall trial start date

01/10/2018

Overall trial end date

01/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women diagnosed with gestational diabetes as per the National Institute for Health and Care Excellence (NICE) criteria at time of consent and who are treated with metformin and/or insulin in pregnancy.
2. Aged 16 years or over at the time of consent.
3. Able and willing to follow a Mediterranean diet until 1 year after childbirth.
4. Smartphone user

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 90; UK Sample Size: 90

Participant exclusion criteria

1. Unable to provide written informed consent in English
2. Diagnosed with pre-existing type 1 or type 2 diabetes
3. Body Mass Index of <= 18.5 kg/m2 or >= 50 kg/m2
4. Allergic to nuts
5. Concomitant participation in:
-another dietary interventional study during pregnancy;
-another interventional study in the postnatal period

Recruitment start date

31/05/2019

Recruitment end date

10/11/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts Research Centre for Women's Health (BARC)
Queen Mary University of London Yvonne Carter Building 58 Turner Street
London
E1 2AB
United Kingdom

Trial participating centre

Barts Health NHS Trust
The Royal London Hospital Whitechapel Rd Whitechapel
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

-
London
E1 4NS
United Kingdom
-
research.governance@qmul.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Barts and the London Charity and Related Charities; Grant Codes: MGU0373

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

California Walnut Commission

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

KTC (Edibles) Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

01/03/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/05/2019: Internal review.