Mobile-Based Lifestyle Intervention in Women with Glucose Intolerance after Gestational Diabetes Mellitus (MELINDA), A Multicenter Randomized Controlled Trial: Methodology and Design

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...

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Published in:Journal of clinical medicine 2020-08, Vol.9 (8), p.2635
Main Authors: Minschart, Caro, Maes, Toon, De Block, Christophe, Van Pottelbergh, Inge, Myngheer, Nele, Abrams, Pascale, Vinck, Wouter, Leuridan, Liesbeth, Mathieu, Chantal, Billen, Jaak, Matthys, Christophe, Weyn, Babs, Laenen, Annouschka, Bogaerts, Annick, Benhalima, Katrien
Format: Article
Language:English
Subjects:
Body mass index
Chromium
Clinical medicine
Clinical trials
Gestational diabetes
Glucose
Intervention
Lifestyles
Metabolism
Overweight
Participation
Pregnancy
Weight control
Womens health
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Summary: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/m or return to pre-gravid weight if BMI < 25 Kg/m ). At each visit blood samples are collected, anthropometric measurements are obtained, and self-administered questionnaires are completed. Recruitment began in May 2019.
ISSN:2077-0383
2077-0383
DOI:10.3390/jcm9082635