Protocol for cost-effectiveness analysis of a randomised trial of mHealth coaching (Bump2Baby and Me) compared with usual care for healthy gestational weight gain and postnatal outcomes in at-risk women and their offspring in the UK, Australia, Ireland and Spain.

INTRODUCTION: Gestational diabetes mellitus and overweight are associated with an increased likelihood of complications during birth and for the newborn baby. These complications lead to increased immediate and long-term healthcare costs as well as reduced health and well-being in women and infants. This protocol presents the health economic evaluation to investigate the cost-effectiveness of Bump2Baby and Me (B2B&Me), which is a health coaching intervention delivered via smartphone to women at risk of gestational diabetes. METHODS AND ANALYSIS: Using data from the B2B&Me randomised controlled trial, this economic evaluation compares costs and health effects between the intervention and control group as an incremental cost-effectiveness ratio. Direct healthcare costs, costs of pharmaceuticals and intervention costs will be included in the analysis, body weight and quality-adjusted life-years for the mother will serve as the effect outcomes. To investigate the long-term cost-effectiveness of the trial, a Markov model will be employed. Deterministic and probabilistic sensitivity analysis will be employed. ETHICS AND DISSEMINATION: The National Maternity Hospital Human Research and Ethics Committee was the primary approval site (EC18.2020) with approvals from University College Dublin HREC-Sciences (LS-E-20-150-OReilly), Junta de Andalucia CEIM/CEI Provincial de Granada (2087-M1-22), Monash Health HREC (RES-20-0000-892A) and National Health Service Health Research Authority and Health and Care Research Wales (HCRW) (21/WA/0022). The results from the analysis will be disseminated in scientific papers, through conference presentations and through different channels for communication within the project. TRIAL REGISTRATION NUMBER: ACTRN12620001240932.

Lifestyle Interventions to Prevent Type 2 Diabetes in Women with a History of Gestational Diabetes: A Systematic Review and Meta-Analysis through the Lens of Health Equity.

BACKGROUND: Type 2 diabetes mellites is one of the health problems disproportionally affecting people with low socioeconomic statuses. Gestational diabetes mellites increases the risk of type 2 diabetes by up to ten-fold for women. Lifestyle interventions prevent type 2 diabetes in women with prior gestational diabetes. However, it is unknown if similar effectiveness can be expected for all population subgroups. OBJECTIVE: This study aims to assess the prevention of type 2 diabetes in women with prior gestational diabetes using population characteristics according to the PROGRESS (place of residence, race/ethnicity/culture/language, occupation, gender/sex, religion, education, socioeconomic status, and social capital) criteria. METHODS: MEDLINE, CINAHL, EMBASE, PubMed, PsycINFO, Web of Science, and EBM Reviews databases were searched for interventional studies of diet, physical activity, or behavioural interventions published up to 21 February 2023. Random effects subgroup meta-analysis was conducted to evaluate the association of population characteristics and intervention effects. RESULTS: All studies were conducted in high-income countries or middle-income countries. Two-thirds of the studies reported on race/ethnicity and education level. Less than one-third reported on place (urban/rural), occupation, and socioeconomic status. None reported on religion or social capital. Studies from high-income countries (MD = -1.46; 95% CI: -2.27, -0.66, I2 = 70.46, p < 0.001) showed a greater reduction in bodyweight compared with the studies conducted in middle-income countries (MD = -0.11; 95% CI: -1.12, 0.89, I2 = 69.31, p < 0.001) (p for subgroup difference = 0.04). CONCLUSION: There are significant equity gaps in the evidence for the prevention of type 2 diabetes in women with prior gestational diabetes due to reports on population characteristics being poor. Interventions may be less effective in reducing bodyweight in women from middle-income countries compared to high-income countries. Collecting and analysing data related to equity is needed to understand the effect of lifestyle interventions on type 2 diabetes for different population subgroups.

Long-term cost-effectiveness of implementing a lifestyle intervention during pregnancy to reduce the incidence of gestational diabetes and type 2 diabetes.

AIMS/HYPOTHESIS: The aim of this study was to determine the long-term cost-effectiveness and return on investment of implementing a structured lifestyle intervention to reduce excessive gestational weight gain and associated incidence of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus. METHODS: A decision-analytic Markov model was used to compare the health and cost-effectiveness outcomes for (1) a structured lifestyle intervention during pregnancy to prevent GDM and subsequent type 2 diabetes; and (2) current usual antenatal care. Life table modelling was used to capture type 2 diabetes morbidity, mortality and quality-adjusted life years over a lifetime horizon for all women giving birth in Australia. Costs incorporated both healthcare and societal perspectives. The intervention effect was derived from published meta-analyses. Deterministic and probabilistic sensitivity analyses were used to capture the impact of uncertainty in the model. RESULTS: The model projected a 10% reduction in the number of women subsequently diagnosed with type 2 diabetes through implementation of the lifestyle intervention compared with current usual care. The total net incremental cost of intervention was approximately AU$70 million, and the cost savings from the reduction in costs of antenatal care for GDM, birth complications and type 2 diabetes management were approximately AU$85 million. The intervention was dominant (cost-saving) compared with usual care from a healthcare perspective, and returned AU$1.22 (95% CI 0.53, 2.13) per dollar invested. The results were robust to sensitivity analysis, and remained cost-saving or highly cost-effective in each of the scenarios explored. CONCLUSIONS/INTERPRETATION: This study demonstrates significant cost savings from implementation of a structured lifestyle intervention during pregnancy, due to a reduction in adverse health outcomes for women during both the perinatal period and over their lifetime.

Economic Evaluation of Prenatal and Postpartum Care in Women With Gestational Diabetes and Hypertensive Disorders of Pregnancy: A Systematic Review.

OBJECTIVES: This study aimed to summarize evidence on the economic outcomes of prenatal and postpartum interventions for the management of gestational diabetes mellitus and hypertensive disorders of pregnancy (HDP), assess the quality of each study, and identify research gaps that may inform future research. METHODS: Electronic databases including PubMed/MEDLINE, Embase, the Cochrane Library, and Cochrane Central Register of Controlled Trials were searched from January 1, 2000, to October 1, 2021. Selected studies were included in narrative synthesis and extracted data were presented in narrative and tabular forms. The quality of each study was assessed using the Consolidated Health Economic Evaluation Reporting Standards and Consensus on Health Economic Criteria list. RESULTS: Among the 22 studies identified through the systematic review, 19 reported favorable cost-effectiveness of the intervention. For prenatal management of HDP, home blood pressure monitoring was found to be cost-effective compared with in-person visits in improving maternal and neonatal outcomes. For postpartum care, regular screening for hypertension or metabolic syndrome followed by subsequent treatment was found to be cost-effective compared with no screening in women with a history of gestational diabetes mellitus or HDP. CONCLUSIONS: Existing economic evaluation studies showed that prenatal home blood pressure monitoring and postpartum screening for hypertension or metabolic syndrome were cost-effective. Nevertheless, limitations in the approach of the current economic evaluations may dampen the quality of the evidence and warrant further investigation.

Perspectives on gestational diabetes mellitus in South Africa.

The field of gestational diabetes mellitus has attracted increasing attention and research in South Africa (SA) over the past decade, creating a better understanding of the disease burden, risk factors, availability of specialised healthcare services, and importantly the far-reaching maternal and childhood consequences beyond the pregnancy. This article brings together all the local published literature in the field and outlines the implications of this condition, together with recommendations regarding particular areas that require attention in order to prevent and alleviate the disease burden in SA.

A Comparison of the Cost-Effectiveness of Lifestyle Interventions in Pregnancy.

OBJECTIVES: Lifestyle interventions during pregnancy improve maternal and infant outcomes. We aimed to compare the cost-effectiveness of 4 antenatal lifestyle intervention types with standard care. METHODS: A decision tree model was constructed to compare lifestyle intervention effects from a novel meta-analysis. The target population was women with singleton pregnancies and births at more than 20 weeks' gestation. Interventions were categorized as diet, diet with physical activity, physical activity, and mixed (lacking structured diet and, or, physical activity components). The outcome of interest was cost per case prevented (gestational diabetes, hypertensive disorders in pregnancy, cesarean birth) expressed as an incremental cost-effectiveness ratio (ICER) from the Australian public healthcare perspective. Scenario analyses were included for all structured interventions combined and by adding neonatal intensive care unit costs. Costs were estimated from published data and consultations with experts and updated to 2019 values. Discounting was not applied owing to the short time horizon. RESULTS: Physical activity interventions reduced adverse maternal events by 4.2% in the intervention group compared with standard care and could be cost saving. Diet and diet with physical activity interventions reduced events by 3.5% (ICER = A$4882) and 2.9% (ICER = A$2020), respectively. Mixed interventions did not reduce events and were dominated by standard care. In scenario analysis, all structured interventions combined and all interventions when including neonatal intensive care unit costs (except mixed) may be cost saving. Probabilistic sensitivity analysis showed that for physical activity and all structured interventions combined, the probability of being cost saving was 58% and 41%, respectively. CONCLUSIONS: Governments can expect a good return on investment and cost savings when implementing effective lifestyle interventions population-wide.

Cost-effectiveness of gestational diabetes screening including prevention of type 2 diabetes: application of the GeDiForCE model in Australia.

AIMS: Gestational diabetes mellitus (GDM) is associated with an increased risk of perinatal complications and of developing type 2 diabetes mellitus (T2DM). A strategy including universal screening following new evidence-based thresholds recommended by the International Association of Diabetes and Pregnancy Study Groups (IADPSG) combined with antenatal care and postpartum lifestyle management could reduce these risks. This new strategy has been endorsed by the Australasian Diabetes in Pregnancy Society (ADIPS) following evidence that showed previous diagnostic thresholds were too high to prevent perinatal adverse events (PAEs) and subsequent T2DM. This study therefore aimed to assess the cost-effectiveness of the new ADIPS GDM strategy in Australia. METHODS: A decision tree model (GeDiForCE) was applied in this study. Our analysis modifies the model and optimizes resource use and cost parameters, to reflect real costs within the Australian context. Data on Australian GDM and T2DM epidemiology, intervention costs and literature were used to estimate model parameters. Costs (in AUD $), averted disability-adjusted life years (DALYs) and net cost per DALY averted during life-time horizon were calculated. Sensitivity analyses were also conducted, by testing the impact of variations in key input variables. RESULTS: Compared to the previous criteria, the new ADIPS strategy costs AUD $20,671 (USD $15,839) per DALY averted in the base case, however sensitivity analyses reveal it is dominant in over half of cases and has a 86% chance of being dominant and/or cost-effective according to WTP threshold of $151,200 international dollars ($I) or $AUD 217,576 per DALY averted (equal to three times per capita GDP). Compared with no screening or treatment, the new ADIPS strategy saves AUD $25,509 (USD $19,547) per DALY averted. CONCLUSIONS: Using local data and literature estimates, this study shows that use of the new Australian Diabetes In Pregnancy Society gestional diabetes mellitus strategy would lead to cost saving care for pregnant women in Australia when compared to a no screening scenario and is likely to be cost effective when compared to previously used criteria.

Association of Antenatal Diet and Physical Activity-Based Interventions With Gestational Weight Gain and Pregnancy Outcomes: A Systematic Review and Meta-analysis.

IMPORTANCE: Excessive gestational weight gain (GWG) is common and associated with adverse pregnancy outcomes. Antenatal lifestyle interventions limit GWG; yet benefits of different intervention types and specific maternal and neonatal outcomes are unclear. OBJECTIVE: To evaluate the association of different types of diet and physical activity-based antenatal lifestyle interventions with GWG and maternal and neonatal outcomes. DATA SOURCES: A 2-stage systematic literature search of MEDLINE, Embase, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, and Health Technology Assessment Database was conducted from February 1, 2017, to May 31, 2020. Search results from the present study were integrated with those from a previous systematic review from 1990 to February 2017. STUDY SELECTION: Randomized trials reporting GWG and maternal and neonatal outcomes. DATA EXTRACTION AND SYNTHESIS: Data were extracted for random-effects meta-analyses to calculate the summary effect estimates and 95% CIs. MAIN OUTCOMES AND MEASURES: Outcomes were clinically prioritized, with mean GWG as the primary outcome. Secondary outcomes included gestational diabetes, hypertensive disorders of pregnancy, cesarean section, preterm delivery, large or small for gestational age neonates, neonatal intensive care unit admission, or fetal death. RESULTS: A total of 117 randomized clinical trials of antenatal lifestyle interventions (involving 34 546 women) were included. Overall lifestyle intervention was associated with reduced GWG (-1.15 kg; 95% CI, -1.40 to -0.91), risk of gestational diabetes (odds ratio [OR], 0.79; 95% CI, 0.70-0.89), and total adverse maternal outcomes (OR, 0.89; 95% CI, 0.84-0.94) vs routine care. Compared with routine care, diet was associated with less GWG (-2.63 kg; 95% CI, -3.87 to -1.40) than physical activity (-1.04 kg; 95% CI, -1.33 to -0.74) or mixed interventions (eg, unstructured lifestyle support, written information with weight monitoring, or behavioral support alone) (-0.74 kg; 95% CI, -1.06 to -0.43). Diet was associated with reduced risk of gestational diabetes (OR, 0.61; 95% CI, 0.45-0.82), preterm delivery (OR, 0.43; 95% CI, 0.22-0.84), large for gestational age neonate (OR, 0.19; 95% CI, 0.08-0.47), neonatal intensive care admission (OR, 0.68; 95% CI, 0.48-0.95), and total adverse maternal (OR, 0.75; 95% CI, 0.61-0.92) and neonatal outcomes (OR, 0.44; 95% CI, 0.26-0.72). Physical activity was associated with reduced GWG and reduced risk of gestational diabetes (OR, 0.60; 95% CI, 0.47-0.75), hypertensive disorders (OR, 0.66; 95% CI, 0.48-0.90), cesarean section (OR, 0.85; 95% CI, 0.75-0.95), and total adverse maternal outcomes (OR, 0.78; 95% CI, 0.71-0.86). Diet with physical activity was associated with reduced GWG (-1.35 kg; 95% CI, -1.95 to -0.75) and reduced risk of gestational diabetes (OR, 0.72; 95% CI, 0.54-0.96) and total adverse maternal outcomes (OR, 0.81; 95% CI, 0.69-0.95). Mixed interventions were associated with reduced GWG only. CONCLUSIONS AND RELEVANCE: This systematic review and meta-analysis found level 1 evidence that antenatal structured diet and physical activity-based lifestyle interventions were associated with reduced GWG and lower risk of adverse maternal and neonatal outcomes. The findings support the implementation of such interventions in routine antenatal care and policy around the world.

Assessment of Caffeine Consumption and Maternal Cardiometabolic Pregnancy Complications.

Importance: Women are recommended to limit caffeine consumption to less than 200 mg per day based on risks to fetal health. Impacts of caffeine on maternal health remain unclear. Objective: To determine whether caffeinated-beverage intake and plasma caffeine and paraxanthine are associated with cardiometabolic complications in pregnancy (ie, gestational diabetes [GDM], preeclampsia, and gestational hypertension [GH]). Design, Setting, and Participants: This cohort study used data from a longitudinal pregnancy cohort study from the National Institute of Child Health and Human Development (NICHD) Fetal Growth Studies-Singletons (2009-2013). This post hoc secondary analysis of 2802 pregnant women without major chronic conditions enrolled at 12 US clinical sites was completed in 2021. The final sample for caffeinated beverage analyses included 2583 women. After excluding women who did not consent to have their biospecimens stored for future research (n = 54), plasma caffeine analyses included 2529 women. Analyses of caffeine consumption and fasting cardiometabolic profiles included 319 women. Exposures: Daily total caffeine intake was estimated at 10 to 13 gestational weeks and 16 to 22 gestational weeks based on self-reported past week intake of caffeinated coffee, tea, soda, and energy drinks. Plasma caffeine and paraxanthine were measured in specimens collected at 10 to 13 weeks. Main Outcomes and Measures: Clinical diagnoses of GDM, preeclampsia, GH, glucose concentrations from GDM screening, and blood pressure were extracted from medical records. Results: Participants had a mean (SD) age of 28.1 (5.5) years and 422 participants (16.3%) were Asian/Pacific Islander women, 741 (28.9%) were Hispanic women, 717 (27.8%) were non-Hispanic Black women, and 703 (27.2%) were non-Hispanic White women. At 10 to 13 weeks, 1073 women (41.5%) reported consuming no caffeinated beverages, 1317 (51.0%) reported consuming 1 mg/d to 100 mg/d, 173 (6.7%) reported consuming 101 mg/d to 200 mg/d, and 20 (0.8%) reported consuming more than 200 mg/d. At 16 to 22 weeks, 599 women (23.6%) reported consuming no caffeinated beverages, 1734 (68.3%) reported consuming 1 mg/d to 100 mg/d, 186 (7.3%) reported consuming 101 mg/d to 200 mg/d, and 20 (0.8%) reported consuming more than 200 mg/d caffeinated beverages. Intake at 16 to 22 weeks was associated with lower GDM risk and lower glucose concentrations (1 mg/d to 100 mg/d vs none: relative risk, 0.53 [95% CI, 0.35 to 0.80]; ß, -2.7 mg/dL [95% CI, -5.4 mg/dL to 0 mg/dL]) and lower C-reactive protein and C-peptide concentrations and favorable lipid profiles. Total plasma caffeine and paraxanthine at 10 to 13 weeks was inversely associated with glucose (quartile 4 vs quartile 1: ß = -3.8 mg/dL [95% CI, -7.0 mg/dL to -0.5 mg/dL]; trend of P = .01). No associations were observed with preeclampsia or GH. Conclusions and Relevance: In this cohort study, second trimester caffeinated beverage intake within current recommendations was associated with lower GDM risk, but not preeclampsia or GH. These findings may be reassuring for women with moderate caffeine intake.

Diet and physical activity in pregnancy to prevent gestational diabetes: a protocol for an individual participant data (IPD) meta-analysis on the differential effects of interventions with economic evaluation.

INTRODUCTION: Mothers with gestational diabetes mellitus (GDM) are at increased risk of pregnancy-related complications and developing type 2 diabetes after delivery. Diet and physical activity-based interventions may prevent GDM, but variations in populations, interventions and outcomes in primary trials have limited the translation of available evidence into practice. We plan to undertake an individual participant data (IPD) meta-analysis of randomised trials to assess the differential effects and cost-effectiveness of diet and physical activity-based interventions in preventing GDM and its complications. METHODS: The International Weight Management in Pregnancy Collaborative Network database is a living repository of IPD from randomised trials on diet and physical activity in pregnancy identified through a systematic literature search. We shall update our existing search on MEDLINE, Embase, BIOSIS, LILACS, Pascal, Science Citation Index, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects and Health Technology Assessment Database without language restriction to identify relevant trials until March 2021. Primary researchers will be invited to join the Network and share their IPD. Trials including women with GDM at baseline will be excluded. We shall perform a one and two stage random-effect meta-analysis for each intervention type (all interventions, diet-based, physical activity-based and mixed approach) to obtain summary intervention effects on GDM with 95% CIs and summary treatment-covariate interactions. Heterogeneity will be summarised using I2 and tau2 statistics with 95% prediction intervals. Publication and availability bias will be assessed by examining small study effects. Study quality of included trials will be assessed by the Cochrane Risk of Bias tool, and the Grading of Recommendations, Assessment, Development and Evaluations approach will be used to grade the evidence in the results. A model-based economic analysis will be carried out to assess the cost-effectiveness of interventions to prevent GDM and its complications compared with usual care. ETHICS AND DISSEMINATION: Ethics approval is not required. The study is registered on the International Prospective Register of Systematic Reviews (CRD42020212884). Results will be submitted for publication in peer-reviewed journals.

Economic Evaluations of Gestational Diabetes Mellitus Screening: A Systematic Review.

BACKGROUND: This study aims to find evidence of the cost-effectiveness of gestational diabetes mellitus (GDM) screening and assess the quality of current economic evaluations, which have shown different conclusions with a variation in screening methods, data sources, outcome indicators, and implementation in diverse organizational contexts. METHODS: Embase, Medline, Web of Science, Health Technology Assessment, database, and National Health Service Economic Evaluation Database databases were searched through June 2019. Studies on economic evaluation reporting both cost and health outcomes of GDM screening programs in English language were selected, and the quality of the studies was assessed using Drummond's checklist. The general characteristics, main assumptions, and results of the economic evaluations were summarized. RESULTS: Our search yielded 10 eligible economic evaluations with different screening strategies compared in different settings and perspectives. The selected papers scored 81% (68-97%) on the items in Drummond's checklist on average. In general, a screening program is cost-effective or even dominant over no screening. The one-step screening, with more cases detected, is more likely to be cost-effective than the two-step screening. Universal screening is more likely to be cost-effective than screening targeting the high-risk population. Parameters affecting cost-effectiveness include: diagnosis criteria, epidemiological characteristics of the population, efficacy of screening and treatment, and costs. CONCLUSIONS: Most studies found GDM screening to be cost-effective, though uncertainties remain due to many factors. The quality assessment identified weaknesses in the economic evaluations in terms of integrating existing data, measuring costs and consequences, analyzing perspectives, and adjusting for uncertainties.

Cost-effectiveness analysis of polycystic ovary syndrome management and the risk of gestational diabetes in pregnant women: a decision-tree model.

BACKGROUND: This study estimated the cost-effectiveness of metformin to reduce the risk of gestational diabetes mellitus (GDM) in pregnant women with polycystic ovary syndrome (PCOS) from the US health-care payer perspective. METHODS: A decision tree was developed to simulate the progression of PCOS in a hypothetical cohort of 10,000 pregnant women diagnosed with PCOS and two scenarios were tested. Normal glucose regulation without developing GDM, average cost-effectiveness ratios (ACER), and the incremental cost-effectiveness ratios (ICERs) were the outcome measures assessed through pregnancy. Evidence from randomized clinical trials and other published literature were used to assess disease progression and its associated health-care costs. Sensitivity analyses that varied key model parameters were conducted. RESULTS: Management of PCOS with metformin was associated with lowest ACER ($669.78 per normal glucose regulation without GDM) as compared to 'no intervention' strategy. Metformin use is the most cost-effective strategy to manage PCOS during pregnancy with average cost savings of $7,593,372.97 and an average effect gain of 2271 of normal glucose regulation without GDM among pregnant women with PCOS. Sensitivity analyses determined that the results are robust. CONCLUSIONS: Management of PCOS during pregnancy may be a cost-effective strategy to reduce GDM risk and its associated complications.

Core outcome set for diabetes after pregnancy prevention across the life span: international Delphi study.

INTRODUCTION: Mothers with gestational diabetes mellitus (GDM) are at high risk of future diabetes. An active area of research examines health behavior change strategies in women within 5 years of a GDM pregnancy to prevent diabetes after pregnancy. We aimed to develop a core outcome set (COS) to facilitate synthesis and comparison across trials. RESEARCH DESIGN AND METHODS: Candidate outcomes were identified through systematic review and scored for importance (1-9) by healthcare professionals, researchers, and women with prior GDM through an international two-round electronic-Delphi survey. Outcomes retained required round two scores above prespecified thresholds (≥70% scoring 7-9) or expert panel endorsement when scores were indeterminate. The panel organized the COS by domain. RESULTS: 115 stakeholders participated in the survey and 56 completed both rounds. SD of scores decreased by 0.24 (95%CI 0.21 to 0.27) by round 2, signaling convergence. The final COS includes 19 domains (50 outcomes): diabetes (n=3 outcomes), other related diseases (n=3), complications in subsequent pregnancy (n=2), offspring outcomes (n=3), adiposity (n=4), cardiometabolic measures (n=5), glycemia (n=3), physical activity (n=2), diet (n=4), breast feeding (n=2), behavior change theory (n=5), diabetes-related knowledge (n=2), health literacy (n=1), social support (n=1), sleep (n=1), quality of life (n=1), program delivery (n=4), health economic evaluation (n=2), and diabetes risk screening (n=2). The seven outcomes endorsed by ≥90% were diabetes development and GDM recurrence, attending the postpartum diabetes screening and completing oral glucose tolerance testing and/or other glycemia measures, weight and total energy intake, and health behaviors in general. Among the 15 at the 80%-90% endorsement level, approximately half were specific elements related to the top 7, while the remainder related to diabetes knowledge, personal risk perception, motivation for change, program element completion, and health service use and cost. CONCLUSION: Researchers should collect and report outcomes from the breadth of domains in the COS.

Barriers and facilitating factors in the prevention of diabetes type 2 and gestational diabetes in vulnerable groups: A scoping review.

AIMS: Type 2 diabetes mellitus (T2DM) and gestational diabetes (GDM) are globally on the rise, accompanied by comorbidities and associated health costs. Increased physical activity, healthy nutrition, and weight loss have shown the potential to prevent T2DM/GDM. Despite this, reaching vulnerable groups remains a key challenge. The aim of this scoping review was to identify barriers and facilitating factors in the prevention of T2DM/GDM in vulnerable groups. METHODS: We conducted a systematic literature search in May 2018, updated in September 2019, in several databases (e.g. PubMed, Embase) to identify barriers and facilitating factors in the prevention of T2DM/GDM in vulnerable groups. Two reviewers independently screened the results. Extracted data was charted, categorized, and summarized. RESULTS: We included 125 articles. Ninety-eight studies were extracted, and eight categories of barriers and facilitating factors were formed. The most common categories of barriers were limited knowledge, family/friends, and economic factors, and the most common categories of facilitating factors were family/friends, social support, and knowledge. CONCLUSION: This scoping review identified various barriers and facilitating factors in vulnerable groups. Preventive interventions should consider these barriers and facilitating factors in developing preventive interventions or in adapting existing ones.

Technology-supported lifestyle interventions to improve maternal-fetal outcomes in women with gestational diabetes mellitus: A meta-analysis.

BACKGROUND: The increasing incidence of gestational diabetes mellitus (GDM) is a global health problem. Lifestyle interventions have been recognized as effective measures to enhance maternal and child health. Traditional education approaches, personalized consultation and home visits to promote change in patients' lifestyle are limited by cost, lack of resources and inability to provide broad coverage. The increased use of technological approaches can cross these barriers. OBJECTIVES: The meta-analysis aimed to evaluate the effectiveness of technology-supported lifestyle interventions for women with gestational diabetes mellitus. METHODS: Databases that were reviewed included the Cochrane Library, PubMed, Web of Science, EBSCO, Embase, Medline, CINAHL and ClinicalTrials.gov. from inception to September 2019. Randomized controlled trials (RCTs) of technology-supported lifestyle interventions used for women with gestational diabetes mellitus (GDM) were identified. Two reviewers independently assessed each study using Cochrane Collaboration's tool. Maternal-fetal outcomes as well as weight gain in pregnancy and maternal blood glucose were presented as relative risks (RR) or a mean difference (MD). RESULTS: Of the 3993 articles reviewed, ten RCTs involving 979 women were included. Technology-supported lifestyle interventions reduced pregnancy weight gain (MD = -1.55, 95% CI = [-1.81 to -1.29], P < 0.001) and mean (1-h and 2-h) postprandial blood glucose (MD = -0.31, 95% CI = [-0.58 to -0.03], P = 0.03), with low heterogeneity of 36% and 18%, respectively. No evidence of significant effect existed on other maternal-fetal outcomes, such as weeks of gestation at delivery, caesarean birth, pre-eclampsia/gestational hypertension, instrumental vaginal birth, premature delivery, newborn weight, neonatal hypoglycemia, large-for-gestational age, fetal macrosomia, NICU admission and respiratory morbidity (I2 ranging from 0% to 51%). No significant improvement was noted in glycosylated hemoglobin (HbA1c) and fasting blood glucose (FBG), with strong heterogeneity of 95% and 84%, respectively. CONCLUSIONS: Technology-supported lifestyle interventions are associated with reducing pregnancy weight gain and mean (1-h and 2-h) postprandial blood glucose in women with GDM. Well-designed research studies are needed to identify the full potential of technology-supported lifestyle interventions, especially interventions guided by theoretical models.

Are Lifestyle Interventions to Reduce Excessive Gestational Weight Gain Cost Effective? A Systematic Review.

PURPOSE OF REVIEW: Lifestyle interventions (such as diet and physical activity) successfully limit excessive gestational weight gain and can reduce some adverse maternal events; however, benefit is variable and cost-effectiveness remains unclear. We aimed to review published cost-effectiveness analyses of lifestyle interventions compared with usual care on clinically relevant outcome measures. Five international and six grey-literature databases were searched from 2007 to 2018. Articles were assessed for quality of reporting. Data were extracted from healthcare and societal perspectives. Costs were adapted to the common currencies of Australia and the United Kingdom by adjusting for resource utilization, healthcare purchase price and changes in costs over time. Included studies were economic analyses of lifestyle interventions aiming to limit weight-gain during pregnancy and/or reduce risk of gestational diabetes, for women with a BMI of 25 or greater in pre- or early-pregnancy. RECENT FINDINGS: Of the 538 articles identified, six were retained for review: one modelling study and five studies in which an economic analysis was performed alongside a randomized-controlled trial. Outcome measures included infant birth-weight, fasting glucose, insulin resistance, gestational weight-gain, infant respiratory distress syndrome, perceived health, cost per case of adverse outcome avoided and quality-adjusted life years (QALYs). Interventions were cost-effective in only one study. Although many studies have investigated the efficacy of lifestyle interventions in pregnancy, few have included cost-effectiveness analyses. Where cost-effectiveness studies were undertaken, results were inconsistent. Secondary meta-analysis, taxonomy and framework research is now required to determine the effective components of lifestyle interventions and to guide future cost-effectiveness analyses.

Cost-utility analysis of lifestyle interventions to prevent type 2 diabetes in women with prior gestational diabetes.

BACKGROUND: To compare estimated costs and health outcomes of lifestyle interventions for the prevention of type 2 diabetes mellitus in women who had gestational diabetes. METHODS: An age-specific Markov model was applied comparing costs and quality-adjusted life years (QALYs) of three alternatives: 'doing nothing'; an annual reminder system (ARS) with an awareness campaign ('ARS-awareness'); and an ARS with an intensive lifestyle intervention ('ARS-ILS'). A healthcare payer perspective was adopted, the time horizon was 30 years and the setting was Flanders (Belgium). Sensitivity analyses were performed. RESULTS: 'ARS-awareness' was extendedly dominated. Per 10 000 participants, 'ARS-ILS' cost €13 210 256 more and gained 496 QALYs compared with 'doing nothing' (26 632 €/QALY), with a 63% probability of being cost effective, given a cost effectiveness threshold of 35 000 €/QALY. A scenario analysis showed that 'ARS-ILS' for 15 years only offered to women with prediabetes (compared with 'doing nothing') has an 89.5% likelihood of being dominant. CONCLUSIONS: 'ARS-ILS' may be the preferred intervention. However, the probability of being cost effective was low. Based on further scenario analyses, we recommend healthcare decision makers to consider the application of a more intensive alternative, focused on the highest risk profiles and with a shorter intervention duration.

A Novel Early Pregnancy Risk Prediction Model for Gestational Diabetes Mellitus.

INTRODUCTION: Accurate early risk prediction for gestational diabetes mellitus (GDM) would target intervention and prevention in women at the highest risk. We evaluated novel biomarker predictors to develop a first-trimester risk prediction model in a large multiethnic cohort. METHODS: Maternal clinical, aneuploidy and pre-eclampsia screening markers (PAPP-A, free hCGß, mean arterial pressure, uterine artery pulsatility index) were measured prospectively at 11-13+6 weeks' gestation in 980 women (248 with GDM; 732 controls). Nonfasting glucose, lipids, adiponectin, leptin, lipocalin-2, and plasminogen activator inhibitor-2 were measured on banked serum. The relationship between marker multiples-of-the-median and GDM was examined with multivariate regression. Model predictive performance for early (< 24 weeks' gestation) and overall GDM diagnosis was evaluated by receiver operating characteristic curves. RESULTS: Glucose, triglycerides, leptin, and lipocalin-2 were higher, while adiponectin was lower, in GDM (p < 0.05). Lipocalin-2 performed best in Caucasians, and triglycerides in South Asians with GDM. Family history of diabetes, previous GDM, South/East Asian ethnicity, parity, BMI, PAPP-A, triglycerides, and lipocalin-2 were significant independent GDM predictors (all p < 0.01), achieving an area under the curve of 0.91 (95% confidence interval [CI] 0.89-0.94) overall, and 0.93 (95% CI 0.89-0.96) for early GDM, in a combined multivariate prediction model. CONCLUSIONS: A first-trimester risk prediction model, which incorporates novel maternal lipid markers, accurately identifies women at high risk of GDM, including early GDM.

A systematic review on costs and cost-effectiveness of screening and prevention of type 2 diabetes in women with prior gestational diabetes: Exploring uncharted territory.

AIMS: Women with gestational diabetes mellitus (GDM) are more likely to develop type 2 diabetes mellitus (T2DM) as compared to women with normoglycemic pregnancies. This study aims to explore the literature on cost(-effectiveness) of screening and prevention of T2DM in women with prior GDM. METHODS: Five databases were systematically searched, inclusion criteria were: (1) women with (prior) GDM; (2) post-partum screening or prevention of T2DM; and (3) health-economic evaluations. No year limits were applied. English, Dutch, French or German publications were included. Quality was assessed using the Consensus Health Economic Criteria checklist. RESULTS: Two cost-effectiveness analyses and two cost analyses were found. One study evaluated nine screening strategies. Three studies evaluated one prevention strategy each: intensive diet and behavioural modification; annual counseling; and an annual dietary consultation. Methodological quality was poor. Perspectives were unclear, time horizons were too short, and no incremental analyses were performed. CONCLUSION: An oral glucose tolerance test per three years leads to the lowest cost per case detected, and prevention is potentially cost-effective or cost-saving. More health economic evaluations are needed that compare all relevant alternatives, including 'doing nothing'.

A lifestyle intervention programme for the prevention of Type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus [LIVING study]: protocol for a randomized trial.

AIM: This study aims to determine whether a resource- and culturally appropriate lifestyle intervention programme in South Asian countries, provided to women with gestational diabetes (GDM) after childbirth, will reduce the incidence of worsening of glycaemic status in a manner that is affordable, acceptable and scalable. METHODS: Women with GDM (diagnosed by oral glucose tolerance test using the International Association of the Diabetes and Pregnancy Study Groups criteria) will be recruited from 16 hospitals in India, Sri Lanka and Bangladesh. Participants will undergo a repeat oral glucose tolerance test at 6 ± 3 months postpartum and those without Type 2 diabetes, a total sample size of 1414, will be randomly allocated to the intervention or usual care. The intervention will consist of four group sessions, 84 SMS or voice messages and review phone calls over the first year. Participants requiring intensification of the intervention will receive two additional individual sessions over the latter half of the first year. Median follow-up will be 2 years. The primary outcome is the proportion of women with a change in glycaemic category, using the American Diabetes Association criteria: (i) normal glucose tolerance to impaired fasting glucose, or impaired glucose tolerance, or Type 2 diabetes; or (ii) impaired fasting glucose or impaired glucose tolerance to Type 2 diabetes. Process evaluation will explore barriers and facilitators of implementation of the intervention in each local context, while trial-based and modelled economic evaluations will assess cost-effectiveness. DISCUSSION: The study will generate important new evidence about a potential strategy to address the long-term sequelae of GDM, a major and growing problem among women in South Asia. (Clinical Trials Registry of India No: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry No: SLCTR/2017/001; and ClinicalTrials.gov Identifier No: NCT03305939).