Nordic Nutrition Recommendations and risk of myocardial infarction and stroke: a prospective cohort study.

PURPOSE: The Nordic Nutrition Recommendations (NNR) are developed to prevent diet-related diseases. This study aimed to examine adherence to the NNR and risk of myocardial infarction (MI) and stroke among women and men in Sweden. METHODS: We followed 34,898 adults from 1997 to 2016. Dietary intake was assessed once at baseline using a food frequency questionnaire. Adherence scores corresponding to NNR-editions from 2023, 2012, 2004 and 1996 were calculated. Scores were categorized into low (reference category), moderate and high adherence. Cox proportional hazards regression models adjusted for potential confounders were used to estimate hazards ratios (HR) with 95% confidence intervals (CI). RESULTS: We identified 1649 incident cases of MI and 2071 incident cases of stroke during follow-up (mean 17.9 years). For each 1-point increase in the NNR2023-score (range 0-9), the rate of MI decreased by 14% (HR: 0.86; 95% CI 0.78-0.95). High adherence was associated with a lower rate of MI (HR: 0.72; 95% CI 0.59-0.87) (p-trend = 0.01). Moderate adherence was associated with a lower rate of stroke (HR: 0.88; 95% CI 0.78-0.99) (p-trend = 0.31). Among women, a 23% lower rate of MI (HR: 0.77; 95% CI 0.67-0.89) was observed for each 1-point increase, and high adherence was associated with a lower rate of MI (HR: 0.59; 95% CI 0.45-0.78). No associations were found in men. The results were similar, though attenuated, for earlier NNR-editions. CONCLUSION: Adherence to the NNR was associated with a reduced risk of MI. This association was more pronounced among women than among men and in more recent NNR-editions. The findings for stroke need further investigation.

Dietary habits after a physical activity mHealth intervention: a randomized controlled trial.

BACKGROUND: A healthy diet and a sufficient amount of physical activity are important factors to reduce complications of type 2 diabetes. Diet and physical activity are associated behaviours. Individuals who are physically active have also been shown to have healthier eating habits than sedentary individuals. We aimed to evaluate the indirect effect of a smartphone-based physical activity intervention on dietary habits in patients with type 2 diabetes. METHODS: We performed analyses of secondary outcomes in a randomized controlled trial. The active intervention was use of a smartphone application to promote physical activity during 12 weeks. Dietary intake was assessed at baseline and after three months using a validated semi-quantitative food frequency questionnaire comprising 94 items. We analysed changes in the intake of fruit and vegetables, snacks, fibre, whole grains, vitamin C, saturated fat, unsaturated fat and total energy. We also assessed overall dietary habits using a dietary index developed by the Swedish National Board of Health and Welfare. Results were compared between the intervention and control group, as well as stratified by sex within the study groups. Paired t-tests and analysis of covariance were performed. RESULTS: A total of 181 patients were recruited to the DiaCert-study, whereof 146 patients had complete dietary data and were included in the analyses. Women in the intervention group had a higher fruit and vegetable intake (p = 0.008) and a higher dietary index (p = 0.007), at three-months compared to women in the control group. They had increased their daily intake of fruit and vegetables by on average 87.4 g/day (p = 0.04) and improved their dietary index by on average 0.8 points (p = 0.01) from baseline to follow-up. No effect was found in men. CONCLUSIONS: Women, but not men, receiving a smartphone-based physical activity intervention improved their total intake of fruit and vegetables. The transfer effect, i.e. an intervention aimed at promoting one health behavior that facilitates changes in other health behaviors, may differ between the sexes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03053336; 15/02/2017.

The effect of the smartphone app DiaCert on health related quality of life in patients with type 2 diabetes: results from a randomized controlled trial.

BACKGROUND: Type 2 diabetes mellitus is associated with an increased risk of impaired quality of life. Improving health related quality of life (HRQoL) is therefore an important goal in the multimodal management of diabetes. The aim of this study was to evaluate whether the use of the smartphone app DiaCert, that encourage physical activity by promoting daily steps, also impacts HRQoL in patients with type 2 diabetes. METHODS: In this randomized controlled trial, a total of 181 participants with type 2 diabetes were recruited from six health care centers in Stockholm, Sweden. At baseline, participants were randomized 1:1 to the use of the smartphone app DiaCert for a 3 month physical activity intervention in addition to routine care, or to a control group with routine care only. HRQoL was measured using the RAND-36 questionnaire at baseline and at follow-up after 3 months and 6 months. We analysed the HRQoL scores within the intervention and the control groups, respectively, using the Wilcoxon signed-rank test. Between group differences including intervention effect after the 3 month long intervention and after 6 months of follow-up, were assessed using generalized estimating equation models. RESULTS: In total, 166 participants, 108 men and 58 women, with complete baseline data on RAND-36 were included in analysis. The mean age was 60.2 (SD 11.4) years and the mean Body Mass Index 30.3 (SD 5.4) kg/m2. The intervention effect, expressed in terms of the difference in change in HRQoL from baseline to follow-up after 3 months of intervention, showed improvement in the health concept role limitations due to physical health problems (- 16.9; 95% CI - 28.5 to - 5.4), role limitations due to emotional problems (- 13.9; 95% CI - 25.8 to - 2.1), and emotional well-being (- 5.7; 95% CI - 10.4 to - 1.0), in the intervention group compared to the control group. No intervention effect was seen at follow-up after 6 months. CONCLUSIONS: Being randomized to use the smartphone app DiaCert promoting physical activity for 3 months, improved aspects of both physical and emotional HRQoL in patients with type 2 diabetes compared to routine care, but the effect did not last 3 months after the intervention ended. Trial Registration ClinicalTrials.gov Identifier: NCT03053336.

Association between total and leisure time physical activity and risk of myocardial infarction and stroke - a Swedish cohort study.

BACKGROUND: Physical inactivity is a known risk factor for cardiovascular disease, but it is unclear if total and leisure time activity have different impact on the risk of myocardial infarction and stroke. In this cohort, we aimed to investigate the associations between both total and leisure time physical activity in detail, and the risks of myocardial infarction and stroke, both overall and for men and women separately. METHODS: We assessed the association between total and leisure time physical activity on the risk of myocardial infarction and stroke in a cohort of 31,580 men and women through record linkages from 1997-2016. We used Cox proportional hazards regression models to estimate hazard ratios (HR) with 95% confidence intervals (CI) based on detailed self-reported physical activity. In the adjusted analyses, we included age, sex, body mass index, level of education, cigarette smoking, alcohol consumption, diabetes, lipid disturbance and hypertension as potential confounders. RESULTS: We identified 1,621 incident cases of myocardial infarction and 1,879 of stroke. Among men, there was an inverse association between leisure time activity and myocardial infarction in the third tertile compared to the first (HR: 0.78; 95% CI: 0.62-0.98; p for trend = 0.03). We also found an inverse association between leisure time activity and stroke in the third tertile compared to the first (HR: 0.78; 95% CI: 0.61-0.99; p for trend = 0.04), while the corresponding HR for stroke among women was 0.91; 95% CI: 0.74-1.13. We found no significant association between total physical activity and MI (HR: 1.12; 95% CI: 0.93-1.34) or stroke (HR: 1.14 95% CI: 0.94-1.39) comparing the highest to the lowest tertile in men. Women in the highest tertile of total physical activity had a 22% lower risk of myocardial infarction compared to the lowest tertile (HR: 0.78; 95% CI: 0.63-0.97; p for trend = 0.02) and an 8% (95% CI: 0.87-0.98) reduced risk of myocardial infarction with each 1 METh/day increase of leisure time physical activity. CONCLUSION: Total physical activity was inversely associated with the risk of myocardial infarction in women, while leisure time physical activity was inversely associated with the risk of myocardial infarction and stroke in men.

App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial.

BACKGROUND: To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. OBJECTIVE: The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. METHODS: The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. RESULTS: A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. CONCLUSIONS: Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19624.

A Questionnaire for Assessing User Satisfaction With Mobile Health Apps: Development Using Rasch Measurement Theory.

BACKGROUND: Mobile health (mHealth) apps offer great opportunities to deliver large-scale, cost-efficient digital solutions for implementing lifestyle changes. Furthermore, many mHealth apps act as medical devices. Yet, there is little research on how to assess user satisfaction with an mHealth solution. OBJECTIVE: This study presents the development of the mHealth Satisfaction Questionnaire and evaluates its measurement properties. METHODS: Respondents who took part in the Health Integrator Study and were randomized to use the Health Integrator smartphone app for lifestyle changes (n=112), with and without additional telephone coaching, rated their satisfaction with the app using the new 14-item mHealth Satisfaction Questionnaire. The ratings were given on a 5-point Likert scale and measurement properties were evaluated using Rasch measurement theory (RMT). RESULTS: Optimal scoring was reached when response options 2, 3, and 4 were collapsed, giving three response categories. After omitting two items that did not fit into the scale, fit residuals were within, or close to, the recommended range of ±2.5. There was no differential item functioning between intervention group, age group, or sex. The Person Separation Index was 0.79, indicating that the scale's ability to discriminate correctly between person leniency was acceptable for group comparisons but not for individual evaluations. The scale did not meet the criterion of unidimensionality; 16.1% (18/112) of the respondents were outside the desired range of -1.96 to 1.96. In addition, several items showed local dependency and three underlying dimensions emerged: negative experiences, positive experiences, and lifestyle consequences of using the mHealth solution. CONCLUSIONS: In times where mHealth apps and digital solutions are given more attention, the mHealth Satisfaction Questionnaire provides a new possibility to measure user satisfaction to ensure usability and improve development of new apps. Our study is one of only a few cases where RMT has been used to evaluate the usability of such an instrument. There is, though, a need for further development of the mHealth Satisfaction Questionnaire, including the addition of more items and consideration of further response options. The mHealth Satisfaction Questionnaire should also be evaluated in a larger sample and with other mHealth apps and in other contexts. TRIAL REGISTRATION: ClinicalTrials.gov NCT03579342; http://clinicaltrials.gov/ct2/show/NCT03579342.

Validation of Two Automatic Blood Pressure Monitors With the Ability to Transfer Data via Bluetooth.

BACKGROUND: Patients with chronic diseases are in need of regular health controls. Diabetes mellitus type 2 is currently the most prevalent chronic metabolic disease. A majority of diabetic patients have at least one comorbid chronic disease, where hypertension is the most common. The standard for blood pressure (BP) measurement is manual BP monitoring at health care clinics. Nevertheless, several advantages of self-measured BP have been documented. With BP data transfer from an automatic BP monitor via Bluetooth to software, for example, a smartphone app, home measurement could effectively be integrated into regular care. OBJECTIVE: The aim of this study was to validate two commercially available automatic BP monitors with the ability to transfer BP data via Bluetooth (Beurer BM 85 and Andersson Lifesense BDR 2.0), against manual BP monitoring in patients with type 2 diabetes. METHODS: A total of 181 participants with type 2 diabetes were recruited from 6 primary care centers in Stockholm, Sweden. BP was first measured using a manual BP monitor and then measured using the two automatic BP monitors. The mean differences between the automatic and manual measurements were calculated by subtracting the manual BP monitor measurement from the automatic monitor measurement. Validity of the two automatic BP monitors was further assessed using Spearman rank correlation coefficients and the Bland-Altman method. RESULTS: In total, 180 participants, 119 men and 61 women, were included. The mean age was 60.1 (SD 11.4) years and the mean body mass index was 30.4 (SD 5.4) kg/m2. The mean difference between the Beurer BM 85 and the manual BP monitor was 11.1 (SD 11.2) mmHg for systolic blood pressure (SBP) and 8.0 (SD 8.1) mmHg for diastolic blood pressure (DBP). The mean difference between the Andersson Lifesense BDR 2.0 and the manual BP monitor was 3.2 (SD 10.8) mmHg for SBP and 4.2 (SD 7.2) mmHg for DBP. The automatic BP measurements were significantly correlated (P<.001) with the manual BP measurement values (Andersson Lifesense BDR 2.0: r=0.78 for SBP and r=0.71 for DBP; Beurer BM 85: r=0.78 for SBP and r=0.69 for DBP). CONCLUSIONS: The two automatic BP monitors validated measure sufficiently accurate on a group level, with the Andersson Lifesense BDR 2.0 more often falling within the ranges for what is acceptable in clinical practice compared with the Beurer BM 85.

A Validation Study of the Web-Based Physical Activity Questionnaire Active-Q Against the GENEA Accelerometer.

BACKGROUND: Valid physical activity assessment in epidemiological studies is essential to study associations with various health outcomes. OBJECTIVE: To validate the Web-based physical activity questionnaire Active-Q by comparing results of time spent at different physical activity levels with results from the GENEA accelerometer and to assess the reproducibility of Active-Q by comparing two admissions of the questionnaire. METHODS: A total of 148 men (aged 33 to 86 years) responded to Active-Q twice and wore the accelerometer during seven consecutive days on two occasions. Time spent on six different physical activity levels including sedentary, light (LPA), moderate (MPA), and vigorous (VPA) as well as additional combined categories of sedentary-to-light and moderate-to-vigorous (MVPA) physical activity was assessed. Validity of Active-Q was determined using Spearman correlation coefficients with 95% confidence intervals (CI) and the Bland-Altman method. Reproducibility was assessed using intraclass correlation coefficients (ICCs) comparing two admissions of the questionnaire. RESULTS: The validity correlation coefficients were statistically significant for time spent at all activity levels; sedentary (r=0.19, 95% CI: 0.04-0.34), LPA (r=0.15, 95% CI: 0.00-0.31), sedentary-to-light (r=0.35, 95% CI: 0.19-0.51), MPA (r=0.27, 95% CI: 0.12-0.42), VPA (r=0.54, 95% CI: 0.42-0.67), and MVPA (r=0.35, 95% CI: 0.21-0.48). The Bland-Altman plots showed a negative mean difference for time in LPA and positive mean differences for time spent in MPA, VPA and MVPA. The ICCs of test-retest reliability ranged between r=0.51-0.80 for the different activity levels in Active-Q. CONCLUSIONS: More moderate and vigorous activities and less light activities were reported in Active-Q compared to accelerometer measurements. Active-Q shows comparable validity and reproducibility to other physical activity questionnaires used today.

How valid are Web-based self-reports of weight?

BACKGROUND: Many studies rely on self-reported anthropometric data. While paper-based self-reports have been the standard collection mode, the number of studies collecting self-reported data via the Web is increasing rapidly. Although numerous studies have shown good agreement between self-reported and measured weight using paper-based questionnaires, the validity of using the Web to inquire about weight is unknown. OBJECTIVE: The objective of this study was to validate Web-based self-reports of bodyweight compared to weight measured at the study center. METHODS: The validity of weight self-reported via the Web was assessed by comparing self-reports against measurements of weight in a convenience sample of 149 individuals (77.2% women, 115/149), aged 20-65 years. Study participants self-reported their weight via a Web-based questionnaire and thereafter had their weight measured in the research center. RESULTS: The Spearman correlation coefficient between self-reported and measured weight was 0.98 (P<.001). The mean difference between self-reported and measured weight was -1.2 (SD 2.6) kg. There was a statistically significant difference between self-reported and measured weight with the self-reported being lower (P<.001). Subjects with a body mass index (BMI) ≥25 kg/m(2), and subjects ≥30 years of age, under-reported their weight statistically significantly more than subjects with a BMI <25 kg/m(2), and subjects <30 years of age, respectively. CONCLUSIONS: Our results show that self-reported weight via the Web can be a valid method of data collection.

Active-Q: validation of the web-based physical activity questionnaire using doubly labeled water.

BACKGROUND: Increased use of the Internet provides new opportunities for collecting data in large studies. The aim of our new Web-based questionnaire, Active-Q, is to assess total physical activity and inactivity in adults. Active-Q assesses habitual activity during the past year via questions in four different domains: (1) daily occupation, (2) transportation to and from daily occupation, (3) leisure time activities, and (4) sporting activities. OBJECTIVE: The objective of our study is to validate Active-Q's energy expenditure estimates using the doubly labeled water (DLW) method, and to assess the reproducibility of Active-Q by comparing the results of the questionnaire completed by the same group on two occasions. METHODS: The validity and reproducibility of Active-Q were assessed in a group of 37 individuals, aged 20 to 65 years. Active-Q was distributed via email to the participants. The total energy expenditure of the participants was assessed using DLW for 11 consecutive days. RESULTS: The median time to complete Active-Q was 6.1 minutes. The majority of participants (27/37, 73%) reported that the questionnaire was "easy" or "very easy" to answer. On average, Active-Q overestimated the total daily energy expenditure by 440 kJ compared with the DLW. The Spearman correlation between the two methods was r = 0.52 (P < .001). The intraclass correlation coefficient for total energy expenditure between the results of Active-Q completed on two occasions was 0.83 (95% CI 0.73-0.93). CONCLUSIONS: Active-Q is a valid and reproducible method of assessing total energy expenditure. It is also a user-friendly method and suitable for Web-based data collection in large epidemiological studies.