Mobile-Based Lifestyle Intervention in Women with Glucose Intolerance after Gestational Diabetes Mellitus (MELINDA), A Multicenter Randomized Controlled Trial: Methodology and Design.
Caro MinschartToon MaesChristophe E M De BlockInge Van PottelberghNele MyngheerPascale AbramsWouter VinckLiesbeth LeuridanChantal MathieuJaak BillenChristophe MatthysBabs WeynAnnouschka LaenenAnnick BogaertsKatrien BenhalimaPublished in: Journal of clinical medicine (2020)
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.
Keyphrases
- randomized controlled trial
- weight loss
- pregnancy outcomes
- primary care
- physical activity
- body mass index
- bariatric surgery
- study protocol
- polycystic ovary syndrome
- blood glucose
- pregnant women
- weight gain
- roux en y gastric bypass
- metabolic syndrome
- cardiovascular disease
- healthcare
- gastric bypass
- quality improvement
- cross sectional
- glycemic control
- type diabetes
- preterm birth
- body weight
- meta analyses