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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr David Simmons


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Vitamin D and lifestyle Intervention for gestational diabetes mellitus (GDM) prevention
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Vitamin D and lifestyle Intervention for gestational diabetes mellitus (GDM) prevention

Not Recruiting

Open to: Female

Age: Adult

Cambridge

Medical Conditions

Gestational diabetes

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


When Diabetes Mellitus is first found during pregnancy it is called Gestational Diabetes Mellitus (GDM). Women with GDM have high levels of glucose (sugar) in their blood. This can have severe consequences for mothers and their children. Prevention of GDM is therefore important. The main aim of this study is to evaluate the effects of three interventions to prevent GDM.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Sep 2012 01 Sep 2014

Publications

2013 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/23829946 protocol2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26112044 results2017 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/28882133 process evaluation2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29540227 cost-effectiveness results2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31182492 results (added 15/04/2020)2019 Other publications in https://pubmed.ncbi.nlm.nih.gov/31845115/ review (added 28/05/2020)2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32069353/ results (added 05/01/2021)

This study looks at the effects of advice on physical activity, advice on diet, vitamin D supplementation, and combinations of these. Participants are randomly allocated to one of the several treatments that are compared. Those allocated to the lifestyle interventions (physical activity, diet or a combination of these two) have personal contact with a lifestyle coach as soon as possible after inclusion in the study. The same coach delivers the nutrition and/or physical activity interventions. Women have five face-to-face sessions with their coach, and three telephone sessions. Women in the vitamin D groups take vitamin D supplements until delivery. The levels of glucose and insulin in the women’s blood are measured at the start of the study and at 24-28 and 35-38 weeks of pregnancy. Weight gain during pregnancy is also measured.


Obese pregnant women before 12 weeks of pregnancy

You can take part if:



You may not be able to take part if:


1. Pre-existing diabetes2. Diagnosed with (gestational) diabetes mellitus before randomisation, defined as fasting glucose ≥ 5.1 mmol/l and/or 1 hour glucose ≥ 10 mmol/l and/or 2 hour glucose ≥ 8.5 mmol/l at baseline3. Not able to walk at least 100 meters safely4. Requirement for complex diets5. Advanced chronic conditions (eg valvular heart disease)6. Sgnificant psychiatric disease7. Unable to speak major language of the country of recruitment fluently8. Known abnormal calcium metabolism (hypo/hyperparathyroidism, nephrolithiasis, hypercalciuria) or hypercalciuria detected at screening (0.6 mmol/mmol creatinine in spot morning urine)9. Twin pregnancy


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Addenbrooke's Treatment Centre
    Cambridge
    CB2 0QQ

Not provided at time of registration

Dr David Simmons



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by VU University Medical Center (Netherlands) and funded by Seventh Framework Programme.




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Read full details for Trial ID: ISRCTN70595832
Last updated 05 January 2021

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