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BackgroundSelf-management is crucial in the daily management of type 2 diabetes. It has been suggested that mHealth may be an important method for enhancing self-management when delivered in combination with health counseling.ObjectiveThe objective of this study was to test whether the use of a mobile phone–based self-management system used for 1 year, with or without telephone health counseling by a diabetes specialist nurse for the first 4 months, could improve glycated hemoglobin A1c (HbA1c) level, self-management, and health-related quality of life compared with usual care.MethodsWe conducted a 3-arm prospective randomized controlled trial involving 2 intervention groups and 1 control group. Eligible participants were persons with type 2 diabetes with an HbA1c level ≥7.1% (≥54.1 mmol/mol) and aged ≥18 years. Both intervention groups received the mobile phone–based self-management system Few Touch Application (FTA). The FTA consisted of a blood glucose–measuring system with automatic wireless data transfer, diet manual, physical activity registration, and management of personal goals, all recorded and operated using a diabetes diary app on the mobile phone. In addition, one intervention group received health counseling based on behavior change theory and delivered by a diabetes specialist nurse for the first 4 months after randomization. All groups received usual care by their general practitioner. The primary outcome was HbA1c level. Secondary outcomes were self-management (heiQ), health-related quality of life (SF-36), depressive symptoms (CES-D), and lifestyle changes (dietary habits and physical activity). Data were analyzed using univariate methods (t test, ANOVA) and multivariate linear and logistic regression.ResultsA total of 151 participants were randomized: 51 to the FTA group, 50 to the FTA-health counseling (FTA-HC) group, and 50 to the control group. Follow-up data after 1 year were available for 120 participants (79%). HbA1c level decreased in all groups, but did not differ between groups after 1 year. The mean change in the heiQ domain skills and technique acquisition was significantly greater in the FTA-HC group after adjusting for age, gender, and education (P=.04). Other secondary outcomes did not differ between groups after 1 year. In the FTA group, 39% were substantial users of the app; 34% of the FTA-HC group were substantial users. Those aged ≥63 years used the app more than their younger counterparts did (OR 2.7; 95% CI 1.02-7.12; P=.045).ConclusionsThe change in HbA1c level did not differ between groups after the 1-year intervention. Secondary outcomes did not differ between groups except for an increase in the self-management domain of skill and technique acquisition in the FTA-HC group. Older participants used the app more than the younger participants did.

Among patients with severe obesity followed up for a median of 6.5 years, bariatric surgery compared with medical treatment was associated with a clinically important increased risk for complications, as well as lower risks of obesity-related comorbidities. The risk for complications should be considered in the decision-making process.

BackgroundSelf-management support for people with type 2 diabetes is essential in diabetes care. Thus, mobile health technology with or without low-intensity theory-based health counseling could become an important tool for promoting self-management.ObjectivesThe aim was to evaluate whether the introduction of technology-supported self-management using the Few Touch Application (FTA) diabetes diary with or without health counseling improved glycated hemoglobin (HbA1c) levels, self-management, behavioral change, and health-related quality of life, and to describe the sociodemographic, clinical, and lifestyle characteristics of the participants after 4 months.MethodsA 3-armed randomized controlled trial was conducted in Norway during 2011-2013. In the 2 intervention groups, participants were given a mobile phone for 1 year, which provided access to the FTA diary, a self-help tool that recorded 5 elements: blood glucose, food habits, physical activity, personal goal setting, and a look-up system for diabetes information. One of the intervention groups was also offered theory-based health counseling with a specialist diabetes nurse by telephone for 4 months from baseline. Both intervention groups and the control group were provided usual care according to the national guidelines. Adults with type 2 diabetes and HbA1c ≥7.1% were included (N=151). There were 3 assessment points: baseline, 4 months, and 1 year. We report the short-term findings after 4 months. HbA1c was the primary outcome and the secondary outcomes were self-management (Health Education Impact Questionnaire, heiQ), behavioral change (diet and physical activity), and health-related quality of life (SF-36 questionnaire). The data were analyzed using univariate methods (ANOVA), multivariate linear, and logistic regression.ResultsData were analyzed from 124 individuals (attrition rate was 18%). The groups were well balanced at baseline. There were no differences in HbA1c between groups after 4 months, but there was a decline in all groups. There were changes in self-management measured using the health service navigation item in the heiQ, with improvements in the FTA group compared to the control group (P=.01) and in the FTA with health counseling group compared with both other groups (P=.04). This may indicate an improvement in the ability of patients to communicate health needs to their health care providers. Furthermore, the FTA group reported higher scores for skill and technique acquisition at relieving symptoms compared to the control group (P=.02). There were no significant changes in any of the domains of the SF-36.ConclusionsThe primary outcome, HbA1c, did not differ between groups after 4 months. Both of the intervention groups had significantly better scores than the control group for health service navigation and the FTA group also exhibited improved skill and technique acquisition.

The comparative effectiveness of various bariatric procedures on remission of type 2 diabetes remains debated. We aimed to compare the two most commonly used procedures, hypothesising higher remission rates of diabetes after gastric bypass than after sleeve gastrectomy. Methods:The Oseberg study is an ongoing triple-blind, randomised, single-centre trial taking place at Vestfold Hospital Trust, Norway. Adult patients with type 2 diabetes and obesity were randomly assigned (1:1) to receive either gastric bypass or sleeve gastrectomy. Randomisation was performed with a computerised random number generator using block sizes of 10. Treatment allocation was concealed using sealed opaque envelopes, and was masked from participants, study personnel and outcome assessors. Primary outcomes were, first, the proportion of participants with complete remission of diabetes; glycated haemoglobin 6•0% (42 mmol/mol) or less with no diabetes medication, and, second, beta-cell function modelled from an intravenous glucose tolerance test at one year. Analyses were performed according to intention-to-treat and per-protocol principles. The trial is registered at ClinicalTrials.gov with identifier: NCT01778738.

Background and aim Lung cancer is increasingly affecting women. The aim of this study was to identify sex-specific trends in lung cancer incidence and survival. Methods Complete national data on 40 118 cases from the Cancer Registry of Norway sampled from 1988 to 2007 are presented, with incidence rates, 1-and 5-year relative survival in 5 year intervals and multivariate HRs adjusted for covariates, each with 95% CIs. Results Lung cancer incidence increased by 64%, with an age-adjusted annual average increase of 4.9% in women and 1.4% in men in this period. Relative survival was lower in men than in women in all time periods, and men had an increased risk of dying within 5 years of diagnosis compared with women (HR 1.14, 95% CI 1.11 to 1.17), adjusted for covariates. Adenocarcinoma is now the most frequent histological group in men and women, yet the risk of dying was higher in men in all histological subtypes except squamous cell carcinoma. A higher proportion of women than men were diagnosed with localised disease, and the risk of dying was significantly higher in men among all stages, most apparent in localised disease (HR 1.25, 95% CI 1.18 to 1.33). Conclusion The findings highlight important characteristics of the lung cancer epidemic; despite a rising incidence of female lung cancer cases, women are diagnosed with less advanced disease than men; when adjusted for covariates, men have an increased risk of excess death at 5 years compared with women, irrespective of stage, age, period of diagnosis and selected histological subgroups.

ObjectiveTo 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.DesignA multicentre, non-blinded randomised controlled trial.SettingFive diabetes outpatient clinics in the Oslo region.ParticipantsWomen ≥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.InterventionThe Pregnant+ app and usual care, the control group received usual care.Primary and secondary outcomesThe 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.ResultsNo 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.ConclusionThe 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.

Objective To examine whether a lifestyle intervention in pregnancy limits gestational weight gain (GWG) and provides measurable health benefits for mother and newborn.Design Randomised controlled trial.Setting Healthcare clinics of southern Norway.Population Healthy, non-diabetic, nulliparous women, aged ≥18 years, with a body mass index of ≥19 kg/m 2 , and with a singleton pregnancy at ≤20 weeks of gestation.Methods Women were randomised to an intervention group (with dietary counselling twice by telephone and access to twiceweekly exercise groups) or to a control group (with standard prenatal care). Participants were measured three times during pregnancy and at delivery, and newborns were measured at delivery. Hospital records were reviewed for outcomes of pregnancy and delivery. Assessors were blinded to group allocation. Analysis was performed by intention to treat, assessing GWG using the Student's t-test and linear mixed models, and comparing proportions using the chi-square test.Main outcome measures GWG, rates of pregnancy complications and operative deliveries, and newborn birthweight.Results A total of 606 women were randomised. Of these, 591 were analysed, with 296 in the intervention group and 295 in the control group. At term, the mean GWG from pre-pregnancy was 14.4 kg for the intervention group and 15.8 kg for the control group (mean difference 1.3 kg; 95% confidence interval, 95% CI 0.3-2.3 kg; P = 0.009). There was no significant difference between groups in the frequency of pregnancy complications or operative deliveries. The intervention demonstrated no effect on the mean birthweight of term infants, or on the proportion of large newborns.Conclusions The Norwegian Fit for Delivery lifestyle intervention in pregnancy had no measurable effect on obstetrical or neonatal outcomes, despite a modest but significant decrease in GWG.Keywords Birthweight, diet, intervention, lifestyle, physical activity, pregnancy, weight gain.Tweetable abstract Norwegian Fit for Delivery RCT: reduced gestational weight gain, unchanged birthweight and obstetric outcomes.