The Melinda project - summary
About 50% of all women with a history of gestational diabetes will develop type 2 diabetes within 10 years after delivery. Women who already develop prediabetes within 6 months after delivery are a particularly high risk group, with about 50% of them who will develop type 2 diabetes within 5 years after the delivery. Therefore, it is important to better understand how many women with a recent history of gestational diabetes develop glucose intolerance early after delivery and which women have an increased risk. With this knowledge, long-term follow-up and lifestyle interventions can be better adapted to the risk profile of women with a history of gestational diabetes.
In general, young mothers lack time to attend intensive lifestyle interventions with many face-to-face sessions. Therefore, lifestyle interventions need to be adapted to the time demands of these women. Because a telephone and mobile-based coaching program can be delivered remotely through an app and lifestyle coach, this will permit a more home-based approach and might as such stimulate a healthy behavior on the long term.
The aim of the Melinda project is to evaluate how many women with a history of gestational diabetes develop prediabetes or diabetes based on the 75g oral glucose tolerance test (OGTT) 6-16 weeks after delivery and what the risk factors are for developing glucose intolerance in early postpartum. The main objective of this project is to investigate the efficacy and feasibility of a telephone and mobile-based lifestyle coaching intervention in women with prediabetes after a recent history of gestational diabetes to promote a healthy lifestyle.
Who can participate in the study?
To be able to participate, you must be: 18 years or older, have a history of gestational diabetes based on the 2013 WHO criteria and have a 75g OGTT 6-16 weeks after delivery in a hospital participating in the study. Because of the increased risk of type 2 diabetes, women with a history of gestational diabetes receive a fasting 75g OGTT as part of a normal follow-up routine 6-16 weeks after delivery. As part of the study, a number of questionnaires will be completed during this OGTT (including diet, physical activity, depression, anxiety, and motivation) and a short clinical examination will be performed (height, weight, abdominal circumference, and blood pressure). This visit does not take longer than in the normal routine.
Women with prediabetes early after delivery will also be invited to participate in a coaching study to investigate the benefits of a telephone and mobile-based lifestyle intervention to promote a healthy lifestyle in women with prediabetes after a recent pregnancy with gestational diabetes. An additional informed consent form will be given to participate in this intervention study. The primary endpoint of this study is to achieve the predetermined target weight after 1 year of coaching. For women with a healthy BMI, this means returning to their weight before pregnancy. For overweight women, this means that at least 5% weight loss is achieved. The aim is to include 236 women in the intervention study.
The participants in the intervention study are divided into a coaching group and a control group. Participants are randomly assigned to one of both groups. Women in the control group receive the same follow-up as in normal routine with referral to the general practitioner. As part of the study, they will receive a 75g OGTT (at the expense of the study) 1 year after the start of the study to detect diabetes. During the OGTT, the same questionnaires are completed and the same clinical examination is performed as at the start of the study.
Women in the intervention group receive a lifestyle intervention to stimulate a healthy lifestyle by means of 1 individual face-to-face coaching session at the hospital of about 1 hour. All further coaching will be done remotely by using an app and monthly telephonic coaching (max. 20 minutes). Participants will be able to follow their weight, abdominal circumference and physical activity in the app, and personalized information, goals and tips concerning a healthy and varied diet and exercise pattern will be provided. Participants also receive a 75g OGTT (at the expense of the study) 1 year after the start of the study to detect diabetes. The same questionnaires are completed and the same clinical examination is performed during the OGTT as at the start of the study.