Mobile-based lifestyle intervention in women with glucose intolerance after gestational diabetes mellitus (Melinda), a multicenter randomized controlled trial: Methodology and design

Abstract

The aims of the ‘Mobile-based lifestyle intervention in women with glucose intolerance after gestational diabetes mellitus (GDM)’ study (MELINDA) are: (1) to evaluate the prevalence and risk factors of glucose intolerance after a recent history of GDM; and (2) to evaluate the efficacy and feasibility of a telephone-and mobile-based lifestyle intervention in women with glucose intolerance after GDM. This is a Belgian multicenter randomized controlled trial (RCT) in seven hospitals with the aim of recruiting 236 women. Women in the intervention group will receive a blended program, based on one face-to-face education session and further follow-up through a mobile application and monthly telephone advice. Women in the control group will receive follow-up as in normal routine with referral to primary care. Participants will receive an oral glucose tolerance test (OGTT) one year after baseline. Primary endpoint is the frequency of weight goal achievement (≥5% weight loss if pre-pregnancy BMI ≥ 25 Kg/m2 or return to pre-gravid weight if BMI<25 Kg/m2 ). At each visit blood samples are collected, anthropometric measurements are obtained, and self-administered questionnaires are completed. Recruitment began in May 2019.