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Improving detection and initial management of gestational diabetes through the primary level of care in Morocco: protocol for a cluster randomized controlled trial.

ABSTRACT: Morocco is facing a growing prevalence of diabetes and according to latest figures of the World Health Organization, already 12.4% of the population are affected. A similar prevalence has been reported for gestational diabetes (GDM) and although it is not yet high on the national agenda, immediate and long-term complications threaten the health of mothers and future generations. A situational analysis on GDM conducted in 2015 revealed difficulties in access to screening and delays in receiving appropriate care. This implementation study has as objective to evaluate a decentralized GDM detection and management approach through the primary level of care and assess its potential for scaling up.We will conduct a hybrid effectiveness-implementation research using a cluster randomized controlled trial design in two districts of Morocco. Using the health center as unit of randomization we randomly selected 20 health centers with 10 serving as intervention and 10 as control facilities. In the intervention arm, providers will screen pregnant women attending antenatal care for GDM by capillary glucose testing during antenatal care. Women tested positive will receive nutritional counselling and will be followed up through the health center. In the control facilities, screening and initial management of GDM will follow standard practice. Primary outcome will be birthweight with weight gain during pregnancy, average glucose levels and pregnancy outcomes including mode of delivery, presence or absence of obstetric or newborn complications and the prevalence of GDM at health center level as secondary outcomes. Furthermore we will assess the quality of life /care experienced by the women in both arms. Qualitative methods will be applied to evaluate the feasibility of the intervention at primary level and its adoption by the health care providers.In Morocco, gestational diabetes screening and its initial management is fragmented and coupled with difficulties in access and treatment delays. Implementation of a strategy that enables detection, management and follow-up of affected women at primary health care level is expected to positively impact on access to care and medical outcomes.The trial has been registered on clininicaltrials.gov ; identifier NCT02979756 ; retrospectively registered 22 November 2016.

SUBMITTER: Utz B

PROVIDER: S-EPMC5477348 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Improving detection and initial management of gestational diabetes through the primary level of care in Morocco: protocol for a cluster randomized controlled trial.

Utz Bettina B Assarag Bouchra B Essolbi Amina A Barkat Amina A El Ansari Nawal N Fakhir Bouchra B Delamou Alexandre A De Brouwere Vincent V

Reproductive health 20170619 1

<h4>Background</h4>Morocco is facing a growing prevalence of diabetes and according to latest figures of the World Health Organization, already 12.4% of the population are affected. A similar prevalence has been reported for gestational diabetes (GDM) and although it is not yet high on the national agenda, immediate and long-term complications threaten the health of mothers and future generations. A situational analysis on GDM conducted in 2015 revealed difficulties in access to screening and de ...[more]

PMID: 28629468

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Project description:BACKGROUND:Gestational Diabetes Mellitus (GDM) testing and management in Morocco is associated with delays resulting in late commencement of treatment. To reduce delays and to increase access of women to GDM care, a country-adapted intervention targeting primary health care providers was designed to test the hypothesis that detection and initial management of GDM at the primary level of care improves newborn outcomes in terms of lower birthweights and less cases of macrosomia and impacts on maternal weight gain, glucose balance and pregnancy outcomes. MATERIALS AND METHODS:We conducted a cluster randomized controlled trial in two districts of Morocco. In each district, 10 health centers were randomly selected to serve either as intervention or control sites. Pregnant women attending antenatal care in the study facilities were eligible to participate. At the intervention sites, women were offered GDM screening by capillary glucose testing following International Association of Diabetes in Pregnancy Study Groups/WHO criteria. Women diagnosed with GDM received counselling on nutrition and exercise and were followed up through their health center whereas at control facilities routine practice was applied. Primary outcome was birthweight and secondary outcomes maternal weight gain, glucose control and pregnancy complications. We further assessed GDM prevalence in the intervention arm. Statistical analysis was performed on 210 recruited women. Continuous variables were reported using means while categorical variables using frequencies with tests of independence applying chi-squared tests. Differences of outcome variables between the two groups were estimated by mixed-effects regression models and effect sizes adjusted for confounders. The trial is registered under NCT02979756 at ClinicalTrials.gov. RESULTS:GDM prevalence reached 23.7% in Marrakech. Birthweight in the intervention group was 147grams lower than in the control group (p = 0.08) as was the proportion of macrosomes (3.5% versus 18.4%; p< 0.001). In the intervention arm, women did two times more follow-ups than at control sites (p = 0.001) and mean follow-up intervals were shorter (11.3 days versus 18.7 days; p < 0.001). Overall, 30% more fasting blood sugar values were balanced (p = 0.005) and mean weekly maternal weight gain 49 grams lower (p = 0.032) in the intervention group. More women from control facilities had a delivery complication whereas more newborn complications were observed in women from intervention facilities. No difference between the two groups existed regarding mode of delivery and mean gestational age at delivery. One of the main limitations of the study was the Hawthorn-effect at control sites that might have led to an underestimation of the effect size. CONCLUSION:A high GDM prevalence in Morocco calls for a context-adapted screening and management approach to enable early interventions. GDM detection and care through antenatal care at primary health facilities may have positively impacted on newborn birthweight but findings are inconclusive. Results of this study will contribute to the decision on a potential upscaling of the intervention in Morocco. Future research could examine long term metabolic changes including diabetes type 2 in the cohort of women and their children.

Project description:BackgroundThe prevalence of gestational diabetes mellitus (GDM) is rising rapidly in many low- and middle-income countries (LMICs). Most women with GDM in LMICs are undiagnosed and/or inadequately managed due to a lack of knowledge and skills about GDM on the part of both providers and patients. Following contextual analysis, we developed an educational/behavioural intervention for GDM delivered through a package of culturally tailored films. This trial aims to evaluate whether the intervention can improve the timely detection and management of GDM in two LMIC settings.MethodsTwo independent cluster randomised controlled trials, one each to be conducted in Uganda and India. Thirty maternity facilities in each country have been recruited to the study and randomised in a 1:1 ratio to the intervention and control arms. The intervention comprises of three interconnected sets of films with the following aims: to improve knowledge of GDM guidelines and skills of health providers, to raise awareness of GDM screening among pregnant women and their families, and to improve confidence and skills in self-management among those diagnosed with GDM. In facilities randomised to the intervention arm, a GDM awareness-raising film will be shown in antenatal care waiting rooms, and four films for pregnant women with GDM will be shown in group settings and made available for viewing on mobile devices. Short films for doctors and nurses will be presented at professional development meetings. Data will be collected on approximately 10,000 pregnant women receiving care at participating facilities, with follow-up at 32 weeks gestational age and 6 weeks postnatally. Women who self-report a GDM diagnosis will be invited for a clinic visit at 34 weeks. Primary outcomes are (a) the proportion of women who report a GDM diagnosis by 32 weeks of pregnancy and (b) glycaemic control (fasting glucose and HbA1C) in women with GDM at ~34 weeks of pregnancy. The secondary outcome is a composite measure of GDM-related adverse perinatal-neonatal outcome.DiscussionScreening and management of GDM are suboptimal in most LMICs. We hypothesise that a scalable film-based intervention has the potential to improve the timely detection and management of GDM in varied LMIC settings.Trial registrationClinicalTrials.gov NCT03937050 , registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605 , registered on 26 February 2020.

Project description:BackgroundGestational diabetes mellitus (GDM) is a form of diabetes that occurs in pregnancy. Although GDM usually resolves following birth, it is associated with significant morbidities for mother and baby both perinatally and in the long term. There is strong evidence to support treatment for GDM. However, there is little consensus on whether or not screening for GDM will improve maternal and infant health and if so, the most appropriate protocol to follow.ObjectivesTo assess the effects of different methods of screening for gestational diabetes mellitus and maternal and infant outcomes.Search strategyWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (April 2010).Selection criteriaRandomised and quasi-randomised trials evaluating the effects of different methods of screening for gestational diabetes mellitus.Data collection and analysisTwo review authors independently conducted data extraction and quality assessment. We resolved disagreements through discussion or through a third author.Main resultsWe included four trials involving 3972 women were included in the review. One quasi-randomised trial compared risk factor screening with universal or routine screening by 50 g oral glucose challenge testing. Women in the universal screening group were more likely to be diagnosed with GDM (one trial, 3152 women, risk ratio (RR) 0.44 95% confidence interval (CI) 0.26 to 0.75). Infants of mothers in the risk factor screening group were born marginally earlier than infants of mothers in the routine screening group (one trial, 3152 women, mean difference -0.15 weeks, 95% CI -0.27 to -0.53).The remaining three trials evaluated different methods of administering a 50 g glucose load. Two small trials compared glucose monomer with glucose polymer testing, with one of these trials including a candy bar group. One trial compared a glucose solution with food. No differences in diagnosis of GDM were found between each comparison. Overall, women drinking the glucose monomer experienced fewer side effects from testing than women drinking the glucose polymer (two trials, 151 women, RR 2.80, 95% CI 1.10 to 7.13). However, we observed high heterogeneity between the trials for this result (I(2) = 61%).Authors' conclusionsThere was insufficient evidence to determine if screening for gestational diabetes, or what types of screening, can improve maternal and infant health outcomes.

Project description:BackgroundGestational diabetes mellitus (GDM) is associated with an increased risk for a future type 2 diabetes mellitus in women and their children. As linkage between maternal health and non-communicable diseases, antenatal care plays a key role in the primary and secondary prevention of GDM associated adverse outcomes. While implementing a locally adapted GDM screening and management approach through antenatal care services at the primary level of care, we assessed its acceptability by the implementing health care providers.MethodsAs part of a larger implementation effectiveness study assessing a decentralized gestational diabetes screening and management approach in the prefecture of Marrakech and the rural district of Al Haouz in Morocco, we conducted four focus group discussions with 29 primary health care providers and seven in-depth interviews with national and regional key informants. After transcription of data, we thematically analyzed the data using a combined deductive and inductive approach.ResultsThe intervention of screening and managing women with gestational diabetes added value to existing antenatal care services but presented an additional workload for first line health care providers. An existing lack of knowledge about gestational diabetes in the community and among private health care physicians required of public providers to spend more time on counselling women. Nurses had to adapt recommendations on diet to the socio-economic context of patients. Despite the additional task, especially nurses and midwives felt motivated by their gained capacity to detect and manage gestational diabetes, and to take decisions on treatment and follow-up.ConclusionsDetection and initial management of gestational diabetes is an acceptable strategy to extend the antenatal care service offer in Morocco and to facilitate service access for affected pregnant women. Despite its additional workload, gestational diabetes management can contribute to the professional motivation of primary level health care providers.Trial registrationclinicaltrials.gov; NCT02979756.

Project description:BackgroundOur objective was to examine whether gestational diabetes mellitus (GDM) or newborns' high birthweight can be prevented by lifestyle counseling in pregnant women at high risk of GDM.Method and findingsWe conducted a cluster-randomized trial, the NELLI study, in 14 municipalities in Finland, where 2,271 women were screened by oral glucose tolerance test (OGTT) at 8-12 wk gestation. Euglycemic (n = 399) women with at least one GDM risk factor (body mass index [BMI] ? 25 kg/m(2), glucose intolerance or newborn's macrosomia (? 4,500 g) in any earlier pregnancy, family history of diabetes, age ? 40 y) were included. The intervention included individual intensified counseling on physical activity and diet and weight gain at five antenatal visits. Primary outcomes were incidence of GDM as assessed by OGTT (maternal outcome) and newborns' birthweight adjusted for gestational age (neonatal outcome). Secondary outcomes were maternal weight gain and the need for insulin treatment during pregnancy. Adherence to the intervention was evaluated on the basis of changes in physical activity (weekly metabolic equivalent task (MET) minutes) and diet (intake of total fat, saturated and polyunsaturated fatty acids, saccharose, and fiber). Multilevel analyses took into account cluster, maternity clinic, and nurse level influences in addition to age, education, parity, and prepregnancy BMI. 15.8% (34/216) of women in the intervention group and 12.4% (22/179) in the usual care group developed GDM (absolute effect size 1.36, 95% confidence interval [CI] 0.71-2.62, p = 0.36). Neonatal birthweight was lower in the intervention than in the usual care group (absolute effect size -133 g, 95% CI -231 to -35, p = 0.008) as was proportion of large-for-gestational-age (LGA) newborns (26/216, 12.1% versus 34/179, 19.7%, p = 0.042). Women in the intervention group increased their intake of dietary fiber (adjusted coefficient 1.83, 95% CI 0.30-3.25, p = 0.023) and polyunsaturated fatty acids (adjusted coefficient 0.37, 95% CI 0.16-0.57, p < 0.001), decreased their intake of saturated fatty acids (adjusted coefficient -0.63, 95% CI -1.12 to -0.15, p = 0.01) and intake of saccharose (adjusted coefficient -0.83, 95% CI -1.55 to -0.11, p ?=? 0.023), and had a tendency to a smaller decrease in MET minutes/week for at least moderate intensity activity (adjusted coefficient 91, 95% CI -37 to 219, p = 0.17) than women in the usual care group. In subgroup analysis, adherent women in the intervention group (n = 55/229) had decreased risk of GDM (27.3% versus 33.0%, p = 0.43) and LGA newborns (7.3% versus 19.5%, p = 0.03) compared to women in the usual care group.ConclusionsThe intervention was effective in controlling birthweight of the newborns, but failed to have an effect on maternal GDM.Trial registrationCurrent Controlled Trials ISRCTN33885819. Please see later in the article for the Editors' Summary.

Project description:In the last decades the presence of social inequalities in diabetes care has been observed in multiple countries, including Spain. These inequalities have been at least partially attributed to differences in diabetes self-management behaviours. Communication problems during medical consultations occur more frequently to patients with a lower educational level. The purpose of this cluster randomized trial is to determine whether an intervention implemented in a General Surgery, based in improving patient-provider communication, results in a better diabetes self-management in patients with lower educational level. A secondary objective is to assess whether telephone reinforcement enhances the effect of such intervention. We report the design and implementation of this on-going study.The study is being conducted in a General Practice located in a deprived neighbourhood of Granada, Spain. Diabetic patients 18 years old or older with a low educational level and inadequate glycaemic control (HbA1c?>?7%) were recruited. General Practitioners (GPs) were randomised to three groups: intervention A, intervention B and control group. GPs allocated to intervention groups A and B received training in communication skills and are providing graphic feedback about glycosylated haemoglobin levels. Patients whose GPs were allocated to group B are additionally receiving telephone reinforcement whereas patients from the control group are receiving usual care. The described interventions are being conducted during 7 consecutive medical visits which are scheduled every three months. The main outcome measure will be HbA1c; blood pressure, lipidemia, body mass index and waist circumference will be considered as secondary outcome measures. Statistical analysis to evaluate the effectiveness of the interventions will include multilevel regression analysis with three hierarchical levels: medical visit level, patient level and GP level.The results of this study will provide new knowledge about possible strategies to promote a better diabetes self-management in a particularly vulnerable group. If effective, this low cost intervention will have the potential to be easily incorporated into routine clinical practice, contributing to decrease health inequalities in diabetic patients.Clinical Trials U.S. National Institutes of Health, NCT01849731.

Project description:IntroductionDiabetes management in primary care remains suboptimal in China, despite its inclusion in the essential public health service (EPHS). We aimed to evaluate the effectiveness of a mobile health (mHealth) based and three-tiered diabetes management system in diverse Chinese contexts.Methods and analysisThis is a cluster randomised controlled trial, named road to hierarchical diabetes management at primary care (ROADMAP). 19?008 patients with type 2 diabetes (T2D) were recruited from primary care clinics in 864 communities across 144 counties/districts of 24 provinces. Eligible participants were adult patients diagnosed with T2D and registered for diabetes management in communities. Patients within the same communities (clusters) were randomly allocated into the intervention or control arm for 1?year in a 2:1 ratio. The control arm patients received usual care as EPHS packaged: at least four blood glucose (BG) and blood pressure (BP) tests, and lifestyle and medication instruction, yearly, from primary care providers. The intervention arm patients received at least two BG and one BP tests, monthly, and lifestyle and treatment instruction from a three-tiered contracted team. A mHealth platform, Graded ROADMAP, enabled test results uploading and sharing, and patient referral within the team. The intervention participants will be further divided into basic or intensive intervention group according to whether they were actively using the Your Doctor App. The primary outcome is the BG control rate with glycated haemoglobin (HbA1c)<7.0%. Secondary outcomes include control rates and changes of ABC (HbA1c, BP and low-density lipoprotein cholesterol) and fasting BG, hypoglycaemia episodes and health-related quality of life (EuroQol (EQ-5D)).Ethics and disseminationThe trial has been approved by the Institutional Review Board at Shanghai Sixth People's Hospital. Findings on the intervention effectiveness will be disseminated through peer-reviewed journals, conference presentations and other relevant mechanisms.Trial registration numberChiCTR-IOC-17011325.

Project description:IntroductionMulti-morbidity, defined as the co-existence of more than one chronic condition in one person, has been increasing due to comorbid non-communicable and infectious chronic diseases (CNCICDs). Type 2 diabetes (T2D) and gestational diabetes mellitus (GDM) incidences within the CNCICDs conditions are increasing and overwhelming already weak and under-resourced healthcare systems in Africa. There is then an urgent need for the integrated management of CNCICDs. We aim to review the integrated management of T2D and GDM within multi-morbidity conditions in Africa.MethodsStudies that have assessed the integrated management of T2D and GDM within multi-morbidity conditions in Africa will be considered based on the Population, Intervention, Comparator and Outcome method: population (adult diagnosed with T2D and GDM, who also have other diseases, non-communicable diseases (NCDs) and infectious, in public primary and secondary healthcare facilities in Africa); Intervention (integrated management of T2D and GDM, also suffering from other diseases in Africa), Comparator (Unintegrated management of T2D and GDM in Africa) and Outcomes (integrated management of T2D and GDM in Africa). The following databases Cochrane Library, MEDLINE, PubMed and SCOPUS, the WHO International Clinical Trials Registry Platform, among others will be searched. Two reviewers (JCM and MW) will independently screen, select eligible studies and extract data. Discrepancies will be resolved by consensus or by a discussion with the third author (AR). Quality of included studies will be assessed using both the newly developed tool, 'the Cochrane Collaboration Risk of Bias Tool' and 'Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I)". A narrative synthesis of extracted data and meta-analysis, if necessary will be conducted and then reported according to the preferred reporting items for systematic review and meta-analysis.Ethics consideration and disseminationBy only using the published data, there is no ethics approval required for this study. This systematic review will be included in JCM's PhD thesis and its findings will also be disseminated through peer-reviewed publication and conference presentation.Prospero registration numberCRD42016046630.

Project description:BACKGROUND:As the management of type 2 diabetes remains suboptimal in primary care, the Road to Hierarchical Diabetes Management at Primary Care (ROADMAP) study was designed and conducted in diverse primary care settings to test the effectiveness of a three-tiered diabetes management model of care in China. OBJECTIVE:This paper aims to predetermine the detailed analytical methods for the ROADMAP study before the database lock to reduce potential bias and facilitate transparent analyses. METHODS:The ROADMAP study adopts a community-based, cluster randomized controlled trial design that compares the effectiveness of a tiered diabetes management model on diabetes control with usual care among patients with diabetes over a 1-year study period. The primary outcome is the control rate of glycated hemoglobin (HbA1c) <7% at 1 year. Secondary outcomes include the control rates of ABC (HbA1c, blood pressure, and low-density lipoprotein cholesterol [LDL-C], individual and combined) and fasting blood glucose, and the change in each outcome. The primary analysis will be the log-binomial regression with generalized estimating equation (GEE), which accounts for the clustering within communities, for binary outcomes and linear regression with GEE for continuous outcomes. For both, the baseline value of the analyzed outcome will be the covariate. The other covariate further adjusted models and the repetitive models after multiple imputation (when more than 10% of observations in HbA1c after 1 year are missing) will be used for sensitivity analysis. Five prespecified subgroup analyses have also been planned to explore the heterogeneity of the intervention effects by adding the subgroup variable and its interaction with the intervention to the primary model. RESULTS:This plan has been finalized, approved, and signed off by the principle investigator, co-principle investigator, and lead statisticians as of November 22, 2019, and made public on the institutional website without any knowledge of intervention allocation. Templates for the main figure and tables are presented. CONCLUSIONS:This statistical analysis protocol was developed for the main results of the ROADMAP study by authors blinded to group allocation and with no access to study data, which will guarantee the transparency and reduce potential bias during statistical analysis. TRIAL REGISTRATION:Chinese Clinical Trial Registry ChiCTR-IOC-17011325; https://tinyurl.com/ybpr9xrq. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/18333.

Dataset Information

Improving detection and initial management of gestational diabetes through the primary level of care in Morocco: protocol for a cluster randomized controlled trial.

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Improving detection and initial management of gestational diabetes through the primary level of care in Morocco: protocol for a cluster randomized controlled trial.

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