Acceptability and adherence to a Mediterranean diet in the postnatal period to prevent type 2 diabetes in women with gestational diabetes in the UK: a protocol for a single-arm feasibility study (MERIT)

Introduction Women with gestational diabetes are at increased risk of developing type 2 diabetes later in life. In at-risk general populations, Mediterranean-style diet helps prevent type 2 diabetes. But its effect on postnatal women with a history of gestational diabetes is not known. Prior to a fu...

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Main Authors: Doris Lanz, Julie Dodds, Graham Hitman, Elena Pizzo, Shakila Thangaratinam, Angeliki Bolou, Zoe Drymoussi, Francisco Jose Gonzalez Carreras, Maria del Carmen Pardo Llorente, Amy Thomas, James Heighway, Anita Sanghi, Angela Harden, Teresa Pérez, Mohammed SB Huda, Anita Mehay, Frances Austin
Format: Article
Language:English
Published: BMJ Publishing Group 2021-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/11/12/e050099.full
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author Doris Lanz
Julie Dodds
Graham Hitman
Elena Pizzo
Shakila Thangaratinam
Angeliki Bolou
Zoe Drymoussi
Francisco Jose Gonzalez Carreras
Maria del Carmen Pardo Llorente
Amy Thomas
James Heighway
Anita Sanghi
Angela Harden
Teresa Pérez
Mohammed SB Huda
Anita Mehay
Frances Austin
author_facet Doris Lanz
Julie Dodds
Graham Hitman
Elena Pizzo
Shakila Thangaratinam
Angeliki Bolou
Zoe Drymoussi
Francisco Jose Gonzalez Carreras
Maria del Carmen Pardo Llorente
Amy Thomas
James Heighway
Anita Sanghi
Angela Harden
Teresa Pérez
Mohammed SB Huda
Anita Mehay
Frances Austin
author_sort Doris Lanz
collection DOAJ
description Introduction Women with gestational diabetes are at increased risk of developing type 2 diabetes later in life. In at-risk general populations, Mediterranean-style diet helps prevent type 2 diabetes. But its effect on postnatal women with a history of gestational diabetes is not known. Prior to a full-scale trial on Mediterranean-style diet in the postnatal period to prevent type 2 diabetes, a feasibility study is required to assess the acceptability of the diet and evaluate the trial processes.Methods and analysis MEditerranean diet for pReventIon of type 2 diabeTes is a single-arm feasibility study (65 women) with qualitative evaluation of women who have recently given birth and had gestational diabetes. The intervention is a Mediterranean-style diet supplemented with nuts and olive oil, with dietary advice and an action plan. A dedicated Health Coach will interact with participants through an interactive lifestyle App. Women will follow the intervention from 6 to 13 weeks post partum until 1 year post partum. The primary outcomes are rates of recruitment, follow-up, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes, and acceptability of the intervention to participants, and to healthcare professionals delivering the intervention. Feasibility outcomes will be reported using descriptive statistics.Ethics and dissemination Ethical approval was obtained through the South Central—Berkshire Research Ethics Committee (19/SC/0064). Study findings will be disseminated via publication in peer-reviewed journals, as well as via newsletters made available to participants and members of Katie’s Team (a women’s health patient and public advisory group).Trial registration number ISRCTN40582975.
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spelling doaj-art-acf7f6ea5e4f41c9b2d2d20336a658d82025-08-20T02:38:58ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-050099Acceptability and adherence to a Mediterranean diet in the postnatal period to prevent type 2 diabetes in women with gestational diabetes in the UK: a protocol for a single-arm feasibility study (MERIT)Doris Lanz0Julie Dodds1Graham Hitman2Elena Pizzo3Shakila Thangaratinam4Angeliki Bolou5Zoe Drymoussi6Francisco Jose Gonzalez Carreras7Maria del Carmen Pardo Llorente8Amy Thomas9James Heighway10Anita Sanghi11Angela Harden12Teresa Pérez13Mohammed SB Huda14Anita Mehay15Frances Austin162 Barts Research Centre for Women`s Health, Wolfson Institute of Population Health, Queen Mary University of London, London, UKBARC (Barts Research Centre for Women’s Health), Wolfson Institute of Population Health, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UKQueen Mary University of London, London, UKApplied Health Research, University College London, London, UKLiverpool Women’s Hospital NHS Foundation Trust, Liverpool, UKInstitute of Lifecourse Development: Centre of Chronic Illness and Aging, Faculty of Education, Health & Human Sciences, University of Greenwich, London, UKBARC (Barts Research Centre for Women’s Health), Wolfson Institute of Population Health, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UKBarts Research Centre for Women`s Health, Institute of Population Health Sciences, Queen Mary University of London Barts and The London School of Medicine and Dentistry, London, UKDepartment of Statistics and Operational Research, Complutense University of Madrid, Madrid, SpainWomen’s Health Research Unit, Barts Health NHS Trust, London, UKBARC (Barts Research Centre for Women’s Health), Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UKObstetrics & Gynaecology, The Royal London Hospital, London, UKCity University of London, London, UKDepartment of Statistics and Data Science, Complutense University of Madrid, Madrid, SpainDepartment of Diabetes & Metabolism, Barts Health NHS Trust, The Royal London Hospital Diabetes Diabetes and Metabolism, London, UKResearch Department of Epidemiology & Public Health, University College London, London, UKWomen`s Health Division, Barts Health NHS Trust, The Royal London Hospital, London, UKIntroduction Women with gestational diabetes are at increased risk of developing type 2 diabetes later in life. In at-risk general populations, Mediterranean-style diet helps prevent type 2 diabetes. But its effect on postnatal women with a history of gestational diabetes is not known. Prior to a full-scale trial on Mediterranean-style diet in the postnatal period to prevent type 2 diabetes, a feasibility study is required to assess the acceptability of the diet and evaluate the trial processes.Methods and analysis MEditerranean diet for pReventIon of type 2 diabeTes is a single-arm feasibility study (65 women) with qualitative evaluation of women who have recently given birth and had gestational diabetes. The intervention is a Mediterranean-style diet supplemented with nuts and olive oil, with dietary advice and an action plan. A dedicated Health Coach will interact with participants through an interactive lifestyle App. Women will follow the intervention from 6 to 13 weeks post partum until 1 year post partum. The primary outcomes are rates of recruitment, follow-up, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes, and acceptability of the intervention to participants, and to healthcare professionals delivering the intervention. Feasibility outcomes will be reported using descriptive statistics.Ethics and dissemination Ethical approval was obtained through the South Central—Berkshire Research Ethics Committee (19/SC/0064). Study findings will be disseminated via publication in peer-reviewed journals, as well as via newsletters made available to participants and members of Katie’s Team (a women’s health patient and public advisory group).Trial registration number ISRCTN40582975.https://bmjopen.bmj.com/content/11/12/e050099.full
spellingShingle Doris Lanz
Julie Dodds
Graham Hitman
Elena Pizzo
Shakila Thangaratinam
Angeliki Bolou
Zoe Drymoussi
Francisco Jose Gonzalez Carreras
Maria del Carmen Pardo Llorente
Amy Thomas
James Heighway
Anita Sanghi
Angela Harden
Teresa Pérez
Mohammed SB Huda
Anita Mehay
Frances Austin
Acceptability and adherence to a Mediterranean diet in the postnatal period to prevent type 2 diabetes in women with gestational diabetes in the UK: a protocol for a single-arm feasibility study (MERIT)
BMJ Open
title Acceptability and adherence to a Mediterranean diet in the postnatal period to prevent type 2 diabetes in women with gestational diabetes in the UK: a protocol for a single-arm feasibility study (MERIT)
title_full Acceptability and adherence to a Mediterranean diet in the postnatal period to prevent type 2 diabetes in women with gestational diabetes in the UK: a protocol for a single-arm feasibility study (MERIT)
title_fullStr Acceptability and adherence to a Mediterranean diet in the postnatal period to prevent type 2 diabetes in women with gestational diabetes in the UK: a protocol for a single-arm feasibility study (MERIT)
title_full_unstemmed Acceptability and adherence to a Mediterranean diet in the postnatal period to prevent type 2 diabetes in women with gestational diabetes in the UK: a protocol for a single-arm feasibility study (MERIT)
title_short Acceptability and adherence to a Mediterranean diet in the postnatal period to prevent type 2 diabetes in women with gestational diabetes in the UK: a protocol for a single-arm feasibility study (MERIT)
title_sort acceptability and adherence to a mediterranean diet in the postnatal period to prevent type 2 diabetes in women with gestational diabetes in the uk a protocol for a single arm feasibility study merit
url https://bmjopen.bmj.com/content/11/12/e050099.full
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