Dataset Information

Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway.

ABSTRACT: 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.

SUBMITTER: Borgen I

PROVIDER: S-EPMC6858205 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway.

Borgen Iren I Småstuen Milada Cvancarova MC Jacobsen Anne Flem AF Garnweidner-Holme Lisa Maria LM Fayyad Seraj S Noll Josef J Lukasse Mirjam M

BMJ open 20191111 11

<h4>Objective</h4>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.<h4>Design</h4>A multicentre, non-blinded randomised controlled trial.<h4>Setting</h4>Five diabetes outpatient clinics in the Oslo region.<h4>Participants</h4>Women ≥18 years old with ...[more]

PMID: 31719080

Similar Datasets

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.

Project description:BackgroundThe prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. A healthy diet and stable blood glucose levels during pregnancy can prevent adverse health outcomes for the mother and the newborn child. Mobile health may be a useful supplement to prenatal care, providing women with targeted dietary information concerning GDM.ObjectiveWe analyzed secondary data from a two-arm, multicentered, nonblinded randomized controlled trial to determine if a smartphone app with targeted dietary information and blood glucose monitoring had an effect on the dietary behavior of women with GDM.MethodsWomen with a 2-hour oral glucose tolerance test level of ≥9 mmol/L were individually randomized to either the intervention group receiving the Pregnant+ app and usual care or the control group receiving usual care only. Eligible women were enrolled from 5 diabetes outpatient clinics in the Oslo region, Norway, between October 2015 and April 2017. The Pregnant+ app promoted 10 GDM-specific dietary recommendations. A healthy dietary score for Pregnant+ (HDS-P+) was constructed from a 41-item food frequency questionnaire and used to assess the intervention effect on the dietary behavior completed at trial entry and at around gestation week 36. Dietary changes from baseline to week 36 were examined by a paired sample two-tailed t test. Between-group dietary differences after the intervention were estimated with analysis of covariance, with adjustment for baseline diet.ResultsA total of 238 women participated: 115 were allocated to the intervention group and 123 to the control group. Of the 238 women, 193 (81.1%) completed the food frequency questionnaire both at baseline and around gestational week 36. All the participants showed improvements in their HDS-P+ from baseline. However, the Pregnant+ app did not have a significant effect on their HDS-P+. The control group reported a higher weekly frequency of choosing fish meals (P=.05). No other significant differences were found between the intervention and control groups. There were no significant demographic baseline differences between the groups, except that more women in the intervention group had a non-Norwegian language as their first language (61 vs 46; P=.02).ConclusionsOur findings do not support the supplementation of face-to-face follow-up of women with GDM with a smartphone app in the presence of high-standard usual care, as the Pregnant+ app did not have a beneficial effect on pregnant women's diet.Trial registrationClinicalTrials.gov NCT02588729; https://clinicaltrials.gov/ct2/show/NCT02588729.

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:ObjectivesPrevious research on seasonal variation in the incidence of gestational diabetes mellitus (GDM) has shown inconclusive results. Furthermore, little is known about whether a seasonal variation in GDM might be associated with the maternal country of birth. We examined whether there was seasonal variation in GDM incidence by the maternal country background.DesignNational population-based registry study.Setting and participantsWe used national population-based data from the Medical Birth Registry of Norway (MBRN), n=1 443 857 (1990-2016) and data from four merged community-based studies (4GDM) with universal screening for GDM, n=2 978 (2002-2013).Outcome measuresThe association between season of pregnancy onset with incidence of GDM was examined separately in both datasets using logistic regression analyses, stratified by the mother's country background using two broad geographical categories (MBRN: Norwegian and immigrant; 4GDM: European and African/Asian ethnicity). Winter season was used as reference category.ResultsThe incidence of GDM in MBRN was highest when the pregnancy started during the winter (Norwegian-born: 1.21%; immigrants: 3.32%) and lowest when pregnancy started during the summer for both Norwegian and immigrant women (Norwegian-born: 1.03% (OR 0.85, 95% CI 0.81 to 0.98); immigrants: 2.99% (OR 0.90, 95% CI 0.84 to 0.96)). The 4GDM data showed that women with European ancestry had the highest incidence of GDM when pregnancy started during autumn (10.7%, OR 1.01, 95% CI 0.69 to 1.46) and winter (10.6%), while ethnic African and Asian women had the highest incidence when pregnancy onset was during the summer (15.3%, OR 1.17, 95% CI 0.54 to 2.53).ConclusionsBased on national population-based data, this study suggests that GDM incidence varies by season in both Norwegian-born and immigrant women. The 4GDM dataset did not show a clear seasonal variation in GDM incidence, possibly due to the relatively small sample. Causes for the seasonal variation in GDM should be explored further.

Dataset Information

Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway.

Publications

Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets