Mediterranean diet to prevent type 2 diabetes in mothers who had diabetes in pregnancy: a feasibility study

Not Applicable

• Conditions: Gestational diabetes; Pregnancy and Childbirth

• Registration Number: ISRCTN40582975
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-15
• Last Update Posted: 3 February 2020
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 83

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Proportion of screened women who are eligible for participation<br> 2. Proportion of eligible women who consent to participate in the study, and who commence the intervention at 6-13 weeks.<br> 3. Rates of follow-up at 6 months and 1 year after delivery.<br> 4. Proportion of recruited women who adhere to the intervention of a Mediterranean based diet. Adherence will be measured as:<br> 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<br> 4.2 Proportion of women who consume nuts and olive oil as self-reported (daily through the App)<br> 4.3 Mediterranean diet adherence as self-reported through the ESTEEM diet questionnaire at 6 months and 12 months postnatally<br>