Mobile-Based Lifestyle Intervention in Women with Glucose Intolerance after Gestational Diabetes Mellitus (MELINDA), A Multicenter Randomized Controlled Trial: Methodology and Design
Caro Minschart, Toon Maes, Christophe De Block, Inge Van Pottelbergh, Nele Myngheer, Pascale Abrams, Wouter Vinck, Liesbeth Leuridan, Chantal Mathieu, Jaak Billen, Christophe Matthys, Babs Weyn, Annouschka Laenen, Annick Bogaerts, Katrien Benhalima
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.