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A web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden (MODIAB-Web): study protocol for a randomized controlled trial.

ABSTRACT: Women with type 1 diabetes face particular demands in their lives in relation to childbearing. During pregnancy, in order to optimize the probability of giving birth to a healthy child, their blood glucose levels need to be as normal as possible. After childbirth, they experience a 'double stress': in addition to the ordinary challenges they face as new mothers, they also need to focus on getting their blood glucose levels normal. To improve self-management of diabetes and overall well-being in women with type 1 diabetes, a person-centered web-based support was designed to be tested in a randomized controlled trial (RCT) to be used during pregnancy and early motherhood. This protocol outlines the design of this RCT, which will evaluate the effectiveness of the specially designed web-based support for mothers with type 1 diabetes in Sweden.The study is designed as an RCT. The web support consists of three parts: 1) evidence-based information, 2) a self-care diary, and 3) communication with peers. The primary outcome is general well-being evaluated with the Well-Being Questionnaire short version (W-BQ12) and diabetes management evaluated with the Diabetes Empowerment Scale, short version (SWE-DES). Women attending six hospital-based antenatal care centers in Sweden are invited to participate. The inclusion period is November 2011 to late 2014. The allocation of participants to web support (intervention group) and to usual care (control group) is equal (1:1). In total, 68 participants in each group will be needed to reach a statistical power of 80% with significance level 0.05.The web support is expected to strengthen the women's personal capacity and autonomy during pregnancy, breastfeeding, and early motherhood, leading to optimal well-being and diabetes management.ClinicalTrials.gov: NCT01565824 (registration date March 27th 2012).

SUBMITTER: Adolfsson A

PROVIDER: S-EPMC4414296 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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A web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden (MODIAB-Web): study protocol for a randomized controlled trial.

Adolfsson Annsofie A Linden Karolina K Sparud-Lundin Carina C Larsson Per-Göran PG Berg Marie M

Trials 20141229

<h4>Background</h4>Women with type 1 diabetes face particular demands in their lives in relation to childbearing. During pregnancy, in order to optimize the probability of giving birth to a healthy child, their blood glucose levels need to be as normal as possible. After childbirth, they experience a 'double stress': in addition to the ordinary challenges they face as new mothers, they also need to focus on getting their blood glucose levels normal. To improve self-management of diabetes and ove ...[more]

PMID: 25543854

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Project description:INTRODUCTION:The incidence of gestational diabetes mellitus (GDM) is increasing and an issue of global concern. GDM can cause severe adverse effects for pregnant women and their fetuses. This systematic review is proposed to explore women's experiences during the pregnancy with GDM. This review will provide insights into the physical, psychological and social adaptation experiences of women with GDM that can help to identify challenges of glycaemic control and provide targeted care and interventions to improve maternal and child health. METHODS AND ANALYSIS:The databases we will search include English databases (ie, PubMed, CINAHL, Embase, the Cochrane Library, Web of Science, Joanna Briggs Institute (JBI) Database of Systematic Reviews, PsycINFO, OpenGrey and Deep Blue) and Chinese databases (ie, China Biology Medicine disc, China National Knowledge Infrastructure, and VIP Database for Chinese Technical Periodicals). Published qualitative evidence of life changes or experiences of the women with GDM will be searched. There will be no limits on publication year. Two reviewers will independently use the JBI Critical Appraisal Checklist for Qualitative Research for methodological validity prior to inclusion in this review. Any disagreements regarding article evaluation will be resolved through discussion or with a third reviewer. Data will be extracted using the standardised data extraction tool from JBI System for the Unified Management, Assessment and Review of Information. Synthesis will include in-depth reading of the original text and the discovery of the results, and then summarising similar categories for more advanced synthesised findings. The final synthesised findings will be graded according to the ConQual approach for establishing confidence. ETHICS AND DISSEMINATION:This study does not require ethical approval as primary data will not be collected. Results of this systematic review will be submitted to peer-reviewed international journals for publication and be presented in relevant international conferences. PROSPERO REGISTRATION NUMBER:CRD42019132065.

Project description:We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families.Prospective, pragmatic, individually randomised controlled trial.3 Maternity Trusts in West Midlands, UK.Following routine midwife systematic assessment of social risk factors, 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care, or addition of referral to a Pregnancy Outreach Worker (POW) service. Those under 16 years and teenagers recruited to the Family Nurse Partnership trial were excluded.POWs were trained to provide individual support and case management for the women including home visiting from randomisation to 6 weeks after birth. Standard maternity care (control) included provision for referring women with social risk factors to specialist midwifery services, available to both arms.Primary outcomes were antenatal visits attended and Edinburgh Postnatal Depression Scale (EPDS) 8-12 weeks postpartum. Prespecified, powered, subgroup comparison was among women with 2 or more social risks. Secondary outcomes included maternal and neonatal birth outcomes; maternal self-efficacy, and mother-to-infant bonding at 8-12 weeks; child development assessment at 6 weeks, breastfeeding at 6 weeks, and immunisation uptake at 4 months, all collected from routine child health systems.Antenatal attendances were high in the standard care control and did not increase further with addition of the POW intervention (10.1 vs 10.1 (mean difference; MD) -0.00, 95% CI (95% CI -0.37 to 0.37)). In the powered subgroup of women with 2 or more social risk factors, mean EPDS (MD -0.79 (95% CI -1.56 to -0.02) was significantly better, although for all women recruited, no significant differences were seen (MD -0.59 (95% CI -1.24 to 0.06). Mother-to-infant bonding was significantly better in the intervention group for all women (MD -0.30 (95% CI -0.61 to -0.00) p=0.05), and there were no differences in other secondary outcomes.This trial demonstrates differences in depressive symptomatology with addition of the POW service in the powered subgroup of women with 2 or more social risk factors. Addition to existing evidence indicates benefit from lay interventions in preventing postnatal depression. This finding is important for women and their families given the known effect of maternal depression on longer term childhood outcomes.ISRCTN35027323; Results.

Project description:Physicians' guideline use rates for diagnosis, treatment and monitoring of diabetes mellitus (DM) is very low. Time constraints, patient overpopulation, and complex guidelines require alternative solutions for real time patient monitoring. Rapidly evolving e-health technology combined with clinical decision support and monitoring systems (CDSMS) provides an effective solution to these problems. The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for the screening, diagnosis, treatment, and monitoring of DM diseases which is used by physicians and patients in primary care and to determine the effectiveness of the system.The CDSMS will be based on evidence-based guidelines for DM disease. A web and mobile-based application will be developed in which the physician will remotely monitor patient data through mobile applications in real time. The developed CDSMS will be tested in two stages. In the first stage, the usability, understandability, and adequacy of the application will be determined. Five primary care physicians will use the developed application for at least 16 DM patients. Necessary improvements will be made according to physician feedback. In the second phase, a parallel, single-blind, randomized controlled trial will be implemented. DM diagnosed patients will be recruited for the CDSMS trial by their primary care physicians. Ten physicians and their 439 patients will be involved in the study. Eligible participants will be assigned to intervention and control groups with simple randomization. The significance level will be accepted as p <?0.05. In the intervention group, the system will make recommendations on patient monitoring, diagnosis, and treatment. These recommendations will be implemented at the physician's discretion. Patients in the control group will be treated by physicians according to current DM treatment standards. Patients in both groups will be monitored for 6 months. Patient data will be compared between 0th and 6th month of the study. . Clinical and laboratory outcomes will be assessed in person while others will be self-assessed online.The developed system will be the first of its kind to utilize evidence based guidelines to provide health services to DM patients.ClinicalTrials.gov NCT02917226 . 28 September 2016.

Project description:OBJECTIVE:To assess the effect of the Pregnant+ app on the 2-hour glucose level of the routine postpartum oral glucose tolerance test (OGTT) among women with gestational diabetes mellitus (GDM). The Pregnant+ app was designed to provide information about GDM, and promote physical activity and a healthy diet. DESIGN:A multicentre, non-blinded randomised controlled trial. SETTING:Five diabetes outpatient clinics in the Oslo region. PARTICIPANTS:Women ≥18 years old with a 2-hour OGTT blood glucose level ≥9 mmol/L who owned a smartphone; understood Norwegian, Urdu or Somali; and were <33 weeks pregnant. A total of 238 women were randomised; 158 women completed the OGTT post partum. INTERVENTION:The Pregnant+ app and usual care, the control group received usual care. PRIMARY AND SECONDARY OUTCOMES:The primary outcome was the 2-hour blood glucose level of the routine postpartum OGTT. Secondary outcomes reported were mode of delivery, induction of labour, Apgar score, birth weight, transfer to the neonatal intensive care unit and breast feeding practice. Blood glucose levels during pregnancy, knowledge of diabetes, diet and physical activity are not reported. RESULTS:No difference was found for the 2-hour blood glucose level of the postpartum OGTT, with 6.7 mmol/L (95% CI 6.2 to 7.1) in the intervention group and 6.0 mmol/L (95% CI 5.6 to 6.3) in the control group. The significant difference in the proportion of emergency caesarean sections between the intervention group, 10 (8.8%) and the usual care group, 27 (22.1%), disappeared when adjusted for parity. There were no differences in birth weight, breast feeding practice, obstetric complications or transfer to the intensive neonatal care unit. No adverse events were registered. CONCLUSION:The Pregnant+ app had no effect on 2-hour glucose level at routine postpartum OGTT. After controlling for parity, the difference in emergency caesarean section was not statistically significant. TRIAL REGISTRATION NUMBER:NCT02588729.

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A web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden (MODIAB-Web): study protocol for a randomized controlled trial.

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A web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden (MODIAB-Web): study protocol for a randomized controlled trial.

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