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Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial.

ABSTRACT: INTRODUCTION:The promotion of a healthy diet, physical activity and measurement of blood glucose levels are essential components in the care for women with gestational diabetes mellitus (GDM). Smartphones offer a new way to promote health behaviour. The main aim is to investigate if the use of the Pregnant+ app, in addition to standard care, results in better blood glucose levels compared with current standard care only, for women with GDM. METHODS AND ANALYSIS:This randomised controlled trial will include 230 pregnant women with GDM followed up at 5 outpatient departments (OPD) in the greater Oslo Region. Women with a 2-hour oral glucose tolerance test (OGTT) ?9?mmol/L, who own a smartphone, understand Norwegian, Urdu or Somali and are <33?weeks pregnant, are invited. The intervention group receives the Pregnant+ app and standard care. The control group receives standard care only. Block randomisation is performed electronically. Data are collected using self-reported questionnaires and hospital records. Data will be analysed according to the intention-to-treat principle. Groups will be compared using linear regression for the main outcome and ?2 test for categorical data and Student's t-test or Mann-Whitney-Wilcoxon test for skewed distribution. The main outcome is the glucose level measured at the 2-hour OGTT 3 months postpartum. Secondary outcomes are a change in health behaviour and knowledge about GDM, quality of life, birth weight, mode of delivery and complications for mother and child. ETHICS AND DISSEMINATION:The study is exempt from regional ethics review due to its nature of quality improvement in patient care. Our study has been approved by the Norwegian Social Science Data Services and the patient privacy protections boards governing over the recruitment sites. Findings will be presented in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER:NCT02588729, Post-results.

SUBMITTER: Borgen I

PROVIDER: S-EPMC5372027 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial.

Borgen Iren I Garnweidner-Holme Lisa Maria LM Jacobsen Anne Flem AF Bjerkan Kirsti K Fayyad Seraj S Joranger Pål P Lilleengen Anne Marie AM Mosdøl Annhild A Noll Josef J Småstuen Milada Cvancarova MC Terragni Laura L Torheim Liv Elin LE Lukasse Mirjam M

BMJ open 20170327 3

<h4>Introduction</h4>The promotion of a healthy diet, physical activity and measurement of blood glucose levels are essential components in the care for women with gestational diabetes mellitus (GDM). Smartphones offer a new way to promote health behaviour. The main aim is to investigate if the use of the Pregnant+ app, in addition to standard care, results in better blood glucose levels compared with current standard care only, for women with GDM.<h4>Methods and analysis</h4>This randomised con ...[more]

PMID: 28348183

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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.

Project description:IntroductionGestational diabetes mellitus (GDM) is a glucose intolerance occurring in 3%-10% of pregnant women and being a risk factor for multiple maternal and fetal complications. The risk of perinatal complications is proportional to the level of maternal hyperglycaemia. Proper glycaemic control is therefore one of the key elements of GDM therapy. Until recently, determination of blood glucose concentration was performed using glucose meters, which involved multiple fingerpricks. Nowadays, due to the flash glucose monitoring (FGM) availability, it is possible to collect measurements at any time without routine puncturing. The aim of the presented study is to assess the impact of FGM on the efficacy of treatment in population of patients diagnosed with GDM.Methods and analysisThis is a prospective, randomised study, that will recruit 100 women at 24-28 weeks of gestation at the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland. Women diagnosed with GDM, who will meet the inclusion criteria, will be individually randomised to the FGM or self-monitoring of blood glucose groups. Further on, clinical and laboratory results of the mother and their newborns will be collected for analysis during the course of pregnancy. Primary outcome is mean glycaemia result in each group after 1 month analysis and percentage of results in the target glycaemic range. The secondary objectives will be to compare the two groups for maternal and neonatal outcomes in conjunction with long-term glycaemic control using blood glycated haemoglobin and fructosamine serum concentrations.Ethics and disseminationThe study is exempt from regional ethics review due to its nature of quality improvement in patient care. The study has been approved by the Bioethics Committee at the Medical University of Warsaw and the patient privacy protection boards governing over the recruitment sites. Results of the study will be presented in peer-reviewed journals and at conferences.Trial registration numberNCT04422821.

Project description:IntroductionPhysical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (GDM). Digital technologies can support PA at scale and remotely. The protocol describes a study designed to determine the feasibility and acceptability of a complex intervention; known as +Stay Active. +Stay Active combines motivational interviewing with a bespoke behaviour change informed smartphone application (Stay-Active) to augment PA levels in women with GDM.Methods and analysisThis is a non-randomised feasibility study using a mixed methods approach. Participants will be recruited from the GDM antenatal clinic at the Women Centre, John Radcliffe Hospital, Oxford. Following baseline assessments (visit 1) including self-reported and device determined PA assessment (wearing a wrist accelerometer), women will be invited to participate in an online motivational interview, then download and use the Stay-Active app (Android or iOS) (visit 2). Women will have access to Stay-Active until 36 weeks gestation, when engagement and PA levels will be reassessed (visit 3). The target sample size is 60 women. Primary outcomes are recruitment and retention rates, compliance and assessment of participant engagement and acceptability with the intervention. Secondary outcomes are assessment of blood glucose control, self-reported and device determined assessment of PA, usage and structured feedback of participant's attitudes to +Stay Active, assessment of health costs and description of maternal and neonatal outcomes. This study will provide key insights into this complex intervention regarding engagement in smartphone technology and the wearing of accelerometers. These data will inform the development of a randomised controlled trial with refinements to intervention implementation.Ethics and disseminationThe study has received a favourable opinion from South Central-Hampshire B Research Ethics Committee; REC reference: 20/SC/0342. Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed journals, conferences and seminar presentations.Trial registration numberISRCTN11366562.

Project description:BackgroundWomen with a history of gestational diabetes mellitus (GDM) are at an increased risk of developing type 2 diabetes mellitus (T2DM). Lifestyle interventions aimed at postpartum weight loss to reduce T2DM risk have been reported, but poor compliance remains a barrier. Smartphone-based interventions may improve compliance, but data on its use in women with recent GDM are limited.ObjectiveThis trial aimed to investigate the efficacy of a smartphone app in restoring optimal weight following delivery in women with GDM, in the setting of a population with high rates of GDM and type 2 diabetes.MethodsIn this unblinded randomized controlled trial, 200 women with GDM were randomized to receive the intervention or standard care following delivery. The intervention enabled logging of weight, meals, and activity, with web-based interaction with a team comprising dieticians, a physiotherapist, and an occupational therapist. The primary outcome was an achievement of optimal weight (defined as the restoration of first trimester weight if first trimester BMI≤23 kg/m2 or weight loss of at least 5% from first trimester weight if first trimester BMI>23 kg/m2) at 4 months post partum. Secondary outcome measures included absolute weight loss, serum metabolic markers, self-reported nutritional intake, health education, and quality of life via questionnaires and user engagement in the intervention group.ResultsIn total, 40% (38/96) of women in the intervention group achieved optimal weight at 4 months post delivery compared with 32% (28/93) in the control group (P=.27). Compared with the control group, women in the intervention group reported significantly reduced caloric intake at 4 months after delivery (P<.001) and higher health-directed behavior scores (P=.045). The intervention group also reported increased emotional distress scores (P=.01). At 4 months, participant engagement with the intervention was maintained at 60.8% (SD 33.9%).ConclusionsAlthough a statistically significant increase in women achieving healthy weight was not observed, this app remains promising, as women in the intervention group reported improved health behaviors and lower caloric intake. Importantly, the high retention rates suggest that a larger study with a longer follow-up period might confirm the effectiveness of this app for weight management.Trial registrationClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737.International registered report identifier (irrid)RR2-10.1186/s12889-019-7691-3.

Project description:IntroductionGestational diabetes mellitus (GDM) has become an increasing health problem among pregnant women in western rural China. Insufficient compliance and motivation due to economic factors is one of the major contributors to the currently low GDM screening and management rate. A subsidy program offering GDM screening and lifestyle management might be an effective way to increase pregnant women's awareness of GDM, and further improve maternal and neonatal health in western rural China. This study had two primary purposes: (1) to examine whether the subsidy program would increase the screening and management rates of GDM and reduce adverse complications for mothers and new-born babies and (2) to evaluate whether the subsidy program is cost-effective from a societal perspective.Methods and analysisThis randomised controlled trial will include 3000 pregnant women (at 24-28 weeks of pregnancy) who will be followed up at six hospitals in the provinces of Yunnan, Sichuan and Shaanxi in China. Pregnant women without overt diabetes, with a singleton pregnancy, with telephone access and with written informed consent will be invited. The intervention group will receive subsidies and standard care, and the control group will only receive usual antenatal care. The randomisation sequence will be stratified by study sites with balanced blocks of six patients. Data will be collected using self-report questionnaires and hospital records. Data will be analysed according to the intention-to-treat principle. The primary outcomes are the maternal and neonatal complications. Secondary outcomes are the mother's cognition scores, screening rate, number of re-examinations, weight gain during pregnancy, changes in diet and exercise, and quality of life. Group comparisons will be conducted using χ2 test for categorical variables, and t-test or the Mann-Whitney-Wilcoxon test for continuous variables where applicable. Multiple logistic regression will also be performed for the primary outcomes.Ethics and disseminationThis study was approved by the Ethics Review Committee of Peking University Health Science Center. Findings will be disseminated through publication in peer-reviewed journals, seminars and national and international conferences.Trial registration numberChiCTR1800017488.

Project description:BackgroundThere is growing attention to the use of mHealth technologies to promote glycemic control for women with GDM around the world, but research on promoting a change in health behaviors is lacking. This study aimed to document the process of designing, developing, and testing the feasibility and acceptability of the SEESPA.MethodsThis single-arm pilot clinical trial study included 15 pregnant women with GDM. Following SEESPA development (e.g., goal setting and action plan, role modeling, motivational messages, mastery of experiences, and tracking healthy behaviors), all participants were provided access to use the SEESPA for 4 weeks. Feasibility outcomes assessed were rates of recruitment, retention rate, success rate of transmitting motivational text messages, rate of participants acknowledging receipt of text messages, and success rate of recording healthy behaviors. Acceptability outcomes were determined by asking open-ended questions through telephone interview at 4-week post-intervention.ResultsFifteen randomly selected women consented to participate in the study, with a 60.0% (n = 9) retention rate at post-trial intervention and 40.0% (n = 6) trial dropout. Two motivational text messages per week were sent to all participants. Of these, 68.1% were acknowledged by the participants. Study participants reported that SEESPA is useful, effective, and they felt satisfied about it. In addition, they brought few suggestions that will be integrated on the final version of the app.Conclusionsand Clinical Relevance. The developed innovative SEESPA is a feasible and acceptable intervention for behavioral modifications among women with GDM, and is ready to be tested in a larger RCT study which is expected to inform the health policymakers to integrate SEESPA with the antenatal health care practice of women with GDM, specifically in developing countries where there is a greater risk of developing GDM complications among mothers and their infants.Trial registrationThe study is registered on September 16, 2019 (ACTRN12619001278123p) by the Australian New Zealand Clinical Trials Registry.

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Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial.

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Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial.

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