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)

IntroductionWomen 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 ful...

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Bibliographic Details
Published in:BMJ open 2021-12, Vol.11 (12), p.e050099
Main Authors: Bolou, Angeliki, Lanz, Doris, Drymoussi, Zoe, Gonzalez Carreras, Francisco Jose, Austin, Frances, Dodds, Julie, Mehay, Anita, Pizzo, Elena, Thomas, Amy, Heighway, James, Sanghi, Anita, Harden, Angela, Pérez, Teresa, Pardo Llorente, Maria del Carmen, Hitman, Graham, Huda, Mohammed SB, Thangaratinam, Shakila
Format: Article
Language:English
Subjects:
Consent
Diabetes and Endocrinology
diabetes in pregnancy
Diet
Feasibility studies
general diabetes
Gestational diabetes
Hospitals
Intervention
Meat
nutrition & dietetics
Nuts
Obstetrics
Olive oil
Participation
Pregnancy
preventive medicine
protocols & guidelines
Public health
Qualitative research
Vegetarianism
Womens health
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Summary:IntroductionWomen 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 analysisMEditerranean 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 disseminationEthical 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 numberISRCTN40582975.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2021-050099