Mothers after Gestational Diabetes in Australia (MAGDA): A Randomised Controlled Trial of a Postnatal Diabetes Prevention Program

Abstract

BackgroundGestational diabetes mellitus (GDM) is an increasingly prevalent risk factor for type 2 diabetes. We evaluated the effectiveness of a group-based lifestyle modification program in mothers with prior GDM within their first postnatal year.Methods and FindingsIn this study, 573 women were randomised to either the intervention (n = 284) or usual care (n = 289). At baseline, 10% had impaired glucose tolerance and 2% impaired fasting glucose. The diabetes prevention intervention comprised one individual session, five group sessions, and two telephone sessions. Primary outcomes were changes in diabetes risk factors (weight, waist circumference, and fasting blood glucose), and secondary outcomes included achievement of lifestyle modification goals and changes in depression score and cardiovascular disease risk factors. The mean changes (intention-to-treat [ITT] analysis) over 12 mo were as follows: −0.23 kg body weight in intervention group (95% CI −0.89, 0.43) compared with +0.72 kg in usual care group (95% CI 0.09, 1.35) (change difference −0.95 kg, 95% CI −1.87, −0.04; group by treatment interaction p = 0.04); −2.24 cm waist measurement in intervention group (95% CI −3.01, −1.42) compared with −1.74 cm in usual care group (95% CI −2.52, −0.96) (change difference −0.50 cm, 95% CI −1.63, 0.63; group by treatment interaction p = 0.389); and +0.18 mmol/l fasting blood glucose in intervention group (95% CI 0.11, 0.24) compared with +0.22 mmol/l in usual care group (95% CI 0.16, 0.29) (change difference −0.05 mmol/l, 95% CI −0.14, 0.05; group by treatment interaction p = 0.331). Only 10% of women attended all sessions, 53% attended one individual and at least one group session, and 34% attended no sessions. Loss to follow-up was 27% and 21% for the intervention and control groups, respectively, primarily due to subsequent pregnancies. Study limitations include low exposure to the full intervention and glucose metabolism profiles being near normal at baseline.ConclusionsAlthough a 1-kg weight difference has the potential to be significant for reducing diabetes risk, the level of engagement during the first postnatal year was low. Further research is needed to improve engagement, including participant involvement in study design; it is potentially more effective to implement annual diabetes screening until women develop prediabetes before offering an intervention.Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12610000338066

Health‐e mums: Evaluating a smartphone app design for diabetes prevention in women with previous gestational diabetes

“…It is possible that participation bias may have been present because people who volunteered for the focus groups may be more likely to be engaged in improving their health or heavy mHealth users. However, the participant sociodemographic characteristics collected are similar to the broader population of women who have previously had GDM …”

“…A lack of engagement will result in participants gaining limited exposure to the intervention and the behaviour change strategies that underpin it. This is a real issue for diabetes prevention programs for women with previous gestational diabetes delivered in face‐to‐face modes . Health‐e Mums took a more user‐centred design approach by applying learnings from previous programs on the unique needs of postnatal women with previous GDM and how those needs might influence the app design and user experience .…”

An evaluation of the impact of lifestyle interventions on body weight in postpartum women: A systematic review and meta‐analysis

“…Impactful health initiatives need to reach (penetration) and engage (participation) a significant proportion of the target population to be effective. Reaching and engaging women after the birth of their child appears to be a particularly challenging task, as evident from low penetration and participation rates (3%–4%) in diabetes prevention programs for postpartum women with a history of gestational diabetes . Such programs would have negligible impact on the target population—despite showing efficacy—given the low penetration and participation rate.…”

Nomograms for incident risk of post‐partum type 2 diabetes in Chinese women with gestational diabetes

“…A further challenge is effectiveness of lifestyle modification interventions in the real world rather than the efficacy shown in the high‐resource, individually targeted randomised controlled trial . Recent studies show lesser degrees of weight loss and predict lesser degrees of reduction in progression to T2D …”

“…Uptake of follow‐up testing and of lifestyle interventions by women who have completed their pregnancy and in many cases have returned to normoglycaemia has also been low as shown by Australian studies which captured women with GDM and prompted follow‐up testing …”