Effectiveness of a Smartphone App to Promote Physical Activity Among Persons With Type 2 Diabetes: Randomized Controlled Trial.

BACKGROUND: Physical activity is well known to have beneficial effects on glycemic control and to reduce risk factors for cardiovascular disease in persons with type 2 diabetes. Yet, successful implementation of lifestyle interventions targeting physical activity in primary care has shown to be difficult. Smartphone apps may provide useful tools to support physical activity. The DiaCert app was specifically designed for integration into primary care and is an automated mobile health (mHealth) solution promoting daily walking. OBJECTIVE: This study aimed to investigate the effect of a 3-month-long intervention promoting physical activity through the use of the DiaCert app among persons with type 2 diabetes in Sweden. Our primary objective was to assess the effect on moderate to vigorous physical activity (MVPA) at 3 months of follow-up. Our secondary objective was to assess the effect on MVPA at 6 months of follow-up and on BMI, waist circumference, hemoglobin A1c, blood lipids, and blood pressure at 3 and 6 months of follow-up. METHODS: We recruited men and women with type 2 diabetes from 5 primary health care centers and 1 specialized center. Participants were randomized 1:1 to the intervention or control group. The intervention group was administered standard care and access to the DiaCert app at baseline and 3 months onward. The control group received standard care only. Outcomes of objectively measured physical activity using accelerometers, BMI, waist circumference, biomarkers, and blood pressure were assessed at baseline and follow-ups. Linear mixed models were used to assess differences in outcomes between the groups. RESULTS: A total of 181 study participants, 65.7% (119/181) men and 34.3% (62/181) women, were recruited into the study and randomized to the intervention (n=93) or control group (n=88). The participants' mean age and BMI were 60.0 (SD 11.4) years and 30.4 (SD 5.3) kg/m2, respectively. We found no significant effect of the intervention (group by time interaction) on MVPA at either the 3-month (ß=1.51, 95% CI -5.53 to 8.55) or the 6-month (ß=-3.53, 95% CI -10.97 to 3.92) follow-up. We found no effect on any of the secondary outcomes at follow-ups, except for a significant effect on BMI at 6 months (ß=0.52, 95% CI 0.20 to 0.84). However, mean BMI did not differ between the groups at the 6-month follow-up. CONCLUSIONS: We found no evidence that persons with type 2 diabetes being randomized to use an app promoting daily walking increased their levels of MVPA at 3 or 6 months' follow-up compared with controls receiving standard care. The effect of the app on BMI was unclear, and we found nothing to support an effect on secondary outcomes. Further research is needed to determine what type of mHealth intervention could be effective to increase physical activity among persons with type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03053336; https://clinicaltrials.gov/study/NCT03053336.

User experiences of an app-based mHealth intervention (MINISTOP 2.0) integrated in Swedish primary child healthcare among Swedish-, Somali- and Arabic-speaking parents and child healthcare nurses: A qualitative study.

Background: Preventive and scalable interventions, accessible to all, to counteract childhood obesity are urgently needed. We have recently developed a novel, digital parental intervention (MINISTOP 2.0 app) available in Swedish, Somali, Arabic and English. We have previously reported its positive effects on children's health behaviors and on parental self-efficacy. However, before introducing the app at scale in primary child healthcare, implementation aspects also need to be explored. Aim: This study aims to explore and describe user experiences as well as acceptability and feasibility of the MINISTOP 2.0 app-based intervention in a diverse group of parents (end-users) and Swedish child healthcare nurses (implementers). Methods: Individual interviews were conducted with Swedish- (n = 9), Somali- (n = 9), Arabic- (n = 5) and English-speaking (n = 1) parents as well as Swedish primary child healthcare nurses (n = 15). Data was analyzed using content analysis with an inductive latent approach. Results: Parents described how the app facilitated behavior change through increased awareness regarding current diet and physical activity behaviors. Furthermore, the evidence-based app content further facilitated trust and behavior change. Both parents and nurses acknowledged the app's preventive potential and the potential for reaching parents with diverse backgrounds or in need of extra support. Conclusion: The MINISTOP 2.0 app was perceived as a useful tool for health promotion both by parents and healthcare professionals, especially since it was adapted to several languages. These findings coupled with the previously shown beneficial effects on health behaviors support the large-scale implementation of the app in primary child healthcare.

A Digital Platform and Smartphone App to Increase Physical Activity in Patients With Type 2 Diabetes: Overview Of a Technical Solution.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-018-5026-4.

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.

Effectiveness of a Smartphone App (MINISTOP 2.0) integrated in primary child health care to promote healthy diet and physical activity behaviors and prevent obesity in preschool-aged children: randomized controlled trial.

BACKGROUND: Childhood overweight and obesity is a public health priority. We have previously reported the efficacy of a parent-oriented mobile health (mHealth) app-based intervention (MINISTOP 1.0) which showed improvements in healthy lifestyle behaviors. However, the effectiveness of the MINISTOP app in real-world conditions needs to be established. OBJECTIVE: To evaluate the real-world effectiveness of a 6-month mHealth intervention (MINISTOP 2.0 app) on children's intake of fruits, vegetables, sweet and savory treats, sweet drinks, moderate-to-vigorous physical activity, and screen time (primary outcomes), and on parental self-efficacy (PSE) for promoting healthy lifestyle behaviors, and children's body mass index (BMI) (secondary outcomes). METHODS: A hybrid type 1 effectiveness-implementation design was utilized. For the effectiveness outcomes, a two-arm, individually randomized controlled trial was conducted. Parents (n = 552) of 2.5-to-3-year-old children were recruited from 19 child health care centers across Sweden, and, randomized to either a control (standard care) or intervention group (MINISTOP 2.0 app). The 2.0 version was adapted and translated into English, Somali and Arabic to increase reach. All recruitment and data collection were conducted by the nurses. Outcomes were assessed at baseline and after six months, using standardized measures (BMI) and a questionnaire (health behaviors, PSE). RESULTS: Among the participating parents (n = 552, age: 34.1 ± 5.0 years), 79% were mothers and 62% had a university degree. Twenty-four percent (n = 132) of children had two foreign-born parents. At follow-up, parents in the intervention group reported lower intakes of sweet and savory treats (-6.97 g/day; p = 0.001), sweet drinks (-31.52 g/day; p < 0.001), and screen time (-7.00 min/day; p = 0.012) in their children compared to the control group. The intervention group reported higher total PSE (0.91; p = 0.006), PSE for promoting healthy diet (0.34; p = 0.008) and PSE for promoting physical activity behaviors (0.31; p = 0.009) compared to controls. No statistically significant effect was observed for children's BMI z-score. Overall, parents reported high satisfaction with the app, and 54% reported using the app at least once a week. CONCLUSION: Children in the intervention group had lower intakes of sweet and savory treats, sweet drinks, less screen time (primary outcomes) and their parents reported higher PSE for promoting healthy lifestyle behaviors. Our results from this real-world effectiveness trial support the implementation of the MINISTOP 2.0 app within Swedish child health care. TRIAL REGISTRATION: Clinicaltrials.gov NCT04147039; https://clinicaltrials.gov/ct2/show/NCT04147039.

Mobile phone-based lifestyle support for families with young children in primary health care (MINISTOP 2.0): Exploring behavioral change determinants for implementation using the COM-B model.

Background: Obesity in childhood is a public health concern worldwide and mobile phone-based interventions (mHealth) has shown to facilitate obesity prevention. However, more research is needed on the implementation of digital tools in routine primary care. This study explored behavior change determinants for implementing a health promotion mHealth intervention (MINISTOP 2.0 app) targeting parents of 4-year-olds. Methods: Secondary data from telephone interviews (n = 15) with child health care nurses working within primary child healthcare in Sweden was analyzed using directed content analysis and the COM-B model. Results: Barriers for implementation included: limited knowledge about using technology and reservations about how and to what extent parents would use mHealth. Potential facilitators included nurses' openness to learn and try new tools, confidence in their role and engagement in reaching parents as well as beliefs that the app could improve practice by prompting dialogue and being a shared platform. Nurses expressed a strong professional identity and shared understanding of their practice, mechanisms that could potentially inhibit or facilitate implementation. Conclusions: Findings suggest cautious optimism regarding implementing mobile phone-based tools in child primary healthcare in terms of capability, opportunity and motivation among stakeholders. Implementation strategies such as educational outreach visits and making the intervention testable among stakeholders could further facilitate implementation in this clinical context. However, more research is needed on behavior change determinants in different stages of real-world implementation.

Adapting a Parental Support App to Promote Healthy Diet and Physical Activity Behaviors (MINISTOP) for a Multi-Ethnic Setting: A Qualitative Study on the Needs and Preferences of Parents and Nurses within Swedish Child Health Care.

Early efforts for prevention of childhood overweight and obesity are needed. In order to adapt an app promoting healthy diet and physical activity behaviors in children (MINISTOP 1.0) for multi-ethnic communities, we explored: (1) needs and concerns among Somali-, Arabic-, and Swedish-speaking parents in terms of supporting healthy diet and activity behaviors in their children; (2) nurses' perceptions of parental needs and concerns in relation to diet and physical activity behaviors; and (3) how the features and content of the MINISTOP 1.0 app could be refined to better support health behaviors in children, among both parents and nurses. Focus groups with Somali-, Arabic-, and Swedish-speaking parents (n = 15), and individual interviews with nurses (n = 15) were conducted. Parents expressed several challenges in supporting children's health behaviors, the need for a tailored app, and alternative ways of accessing the content (audio/video). Nurses emphasized the need of supporting parents early, and the value of a shared platform in different languages, to facilitate communication. This study contributes valuable insights about parental needs and relevant adaptations to a parental support app, such as addition of audio/video files for increased accessibility. This adapted app version-MINISTOP 2.0, can be useful for childhood obesity prevention in multi-ethnic communities.

International Study of Movement Behaviors in the Early Years (SUNRISE): Results from SUNRISE Sweden's Pilot and COVID-19 Study.

The International Study of Movement Behaviors in the Early Years (SUNRISE) was initiated in response to the 2019 WHO guidelines for physical activity, sedentary behavior, and sleep in children aged 0-5 years. This Swedish pilot study aimed to: (i) assess the proportion of preschoolers meeting the guidelines, (ii) evaluate the feasibility of the methods for the SUNRISE study, and (iii) assess how movement behaviors have been affected in preschoolers during the COVID-19 pandemic. Physical activity and sleep (waist-worn ActiGraph); screen time and movement behaviors (parental questionnaire); motor skills (Ages and Stages Questionnaire); and executive functions (3 iPad games) were assessed in 100 Swedish preschoolers (n = 58 boys). There were 19.4% of preschoolers (n = 14) who met the WHO guidelines. The motor skill and executive function assessments were feasible; however, 20% refused to wear the ActiGraph overnight. Additionally, during the pandemic Swedish children's physical activity, time spent outside on weekdays and weekend days, and screen time significantly increased (+53; +124; +68; +30min/day, respectively, all p-values ≤ 0.001). Methods for the SUNRISE study were feasible in a Swedish context; however, considerations to switch to a wrist-worn accelerometer should be made. Furthermore, children's physical activity increased during the pandemic, which is likely due to how the rules/restrictions were implemented in Sweden.

MINISTOP 2.0: a smartphone app integrated in primary child health care to promote healthy diet and physical activity behaviours and prevent obesity in preschool-aged children: protocol for a hybrid design effectiveness-implementation study.

BACKGROUND: Childhood obesity is still a major health problem in many countries, including Sweden. Childhood obesity and obesity-related behaviours in childhood, such as low physical activity and unhealthy eating habits, tend to track into adulthood, which highlights the need for early prevention. Our aims are to evaluate whether a parent-oriented mobile health app (the MINISTOP 2.0 app) integrated into primary child health care can improve diet and physical activity behaviours and reduce the prevalence of overweight and obesity in preschool-aged children as well as to evaluate the implementation among child health care nurses and parents. METHODS: This trial uses a hybrid type 1 effectiveness-implementation design. Families (n = 500) who attend a routine visit to one of 15-20 primary child health care centres throughout Sweden, when their child is 2.5 years, are offered participation in a randomised controlled trial (effectiveness evaluation). After acceptance, families will be randomised (1:1) to control or intervention groups. The intervention group receives a 6-month parent-oriented smartphone intervention aimed at improving the dietary and activity behaviours of their child (the MINISTOP 2.0 app) and the control group receives routine child health care. Dietary habits, physical activity and screen time (primary outcomes), body weight and height in children, and parental self-efficacy (secondary outcomes) are measured at baseline and at 6 months post randomisation. Implementation outcomes (i.e. perceived acceptability, appropriateness, and feasibility) of the intervention will be assessed among primary child health care nurses and parents in the trial through questionnaires and qualitative interviews. DISCUSSION: This trial will evaluate whether the MINISTOP 2.0 app can be used in primary child health care to improve diet and physical activity behaviours, and prevent overweight and obesity, in preschool-aged children. If effectiveness is proven, and the MINISTOP 2.0 app is considered acceptable, appropriate and feasible, it can be implemented nationally as part of the preventive strategies to combat childhood obesity provided by routine child health care. TRIAL REGISTRATION: The trial was registered at the Clinicaltrials.gov register platform (ID NCT04147039 ) on 31 October 2019.

User Perception of a Smartphone App to Promote Physical Activity Through Active Transportation: Inductive Qualitative Content Analysis Within the Smart City Active Mobile Phone Intervention (SCAMPI) Study.

BACKGROUND: Physical inactivity is globally recognized as a major risk factor for morbidity, particularly the incidence of noncommunicable diseases. Increasing physical activity (PA) is therefore a public health priority. Engaging in active transportation (AT) is a viable approach for promoting daily PA levels. Mobile health interventions enable the promotion of AT to a larger population. The Smart City Active Mobile Phone Intervention (SCAMPI) study was a randomized controlled trial designed to evaluate the ability of a behavior change program delivered via a smartphone app to motivate participants to increase their PA by engaging in AT. OBJECTIVE: This qualitative study aims to examine the acceptance and user experience of the app promoting AT that was used in the SCAMPI trial (the TRavelVU Plus app). METHODS: A total of 17 residents of Stockholm County (13 women; age range 25-61 years) who completed the 3-month app-based behavioral change program (delivered through the TRavelVU Plus app) in the SCAMPI randomized controlled trial during 2018 agreed to participate in a semistructured telephone-based interview. These participants were well representative of the whole intervention group (n=127) in terms of baseline characteristics such as age, sex, and area of residence. The interviews were audiorecorded, transcribed verbatim, and analyzed using an inductive qualitative content analysis. RESULTS: The content analysis revealed 2 themes and 4 subcategories. The first theme, "main motivators: monitoring and messages," highlighted that monitoring AT and being able to set weekly goals using the app were the primary motivators reported by study participants. The second theme, "acceptable but modifiable," reflects that the app was well accepted and effectively encouraged many participants to use more AT. Nevertheless, there were functions in the app that require modification. For example, while the semiautomated travel tracking feature was appreciated, participants found it time-consuming and unreliable at times. CONCLUSIONS: This study contributes novel insight into adults' experiences of using a mobile app to promote the use of AT. The results showed that the app was well accepted and that self-monitoring and goal setting were the main motivators to engage in more AT. The semiautomated tracking of AT was appreciated; however, it was also reported to be energy- and time-consuming when it failed to work. Thus, this feature should be improved going forward. TRIAL REGISTRATION: ClinicalTrials.gov NCT03086837; https://clinicaltrials.gov/ct2/show/NCT03086837. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-018-5658-4.

Effectiveness of a 3-Month Mobile Phone-Based Behavior Change Program on Active Transportation and Physical Activity in Adults: Randomized Controlled Trial.

BACKGROUND: Active transportation (AT; ie, walking and cycling as a mode for transportation) has been associated with decreased morbidity and mortality; however, low-cost and scalable intervention programs are lacking. OBJECTIVE: The goal of the research was to determine the effectiveness of a 3-month behavior change program delivered via a mobile phone app to promote AT (TravelVu Plus) on time spent in moderate-to-vigorous physical activity (MVPA). METHODS: For this 2-arm parallel randomized controlled trial, we recruited a population-based sample of 254 adults from Stockholm County who were aged 20 to 65 years and had access to a smartphone. On completion of 1-week baseline measures, the 254 participants were randomized to either the control or intervention group (1:1 ratio). Both groups had access to the standard TravelVu app (Trivector AB) for monitoring their AT for 6 months. The intervention group also received a 3-month behavior change program to promote AT (TravelVu Plus app). Assessors of outcomes were blinded to group allocation. Outcomes were objectively measured MVPA at 3 (primary) and 6 months. Secondary outcomes were AT, attitudes toward AT, and health-related quality of life at 3 and 6 months. RESULTS: No effect on MVPA was observed after 3 months (P=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; P=.04]). A Bayesian analyses showed that there was a 98% probability that the intervention had any effect at 6 months, and a 63% probability that this effect was >5 minute MVPA per day. CONCLUSIONS: No effect on MVPA immediately after the intervention period (at 3 months) was observed; however, there was a delayed effect on MVPA (6 minutes per day) at 6 months, which corresponds to approximately 30% of the weekly MVPA recommendation. Our findings suggest that a behavior change program promoting AT delivered via an app may have a relevant effect on PA. TRIAL REGISTRATION: ClinicalTrials.gov NCT03086837; https://clinicaltrials.gov/ct2/show/NCT03086837. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-018-5658-4.

Compliance with the 24-h movement guidelines and the relationship with anthropometry in Finnish preschoolers: the DAGIS study.

BACKGROUND: Recent 24-h movement guidelines for the early years established recommendations for physical activity (PA), screen time (ST), and sleep. To date, few studies have focused on compliance with meeting the guidelines and their associations with health outcomes. Thus, we aimed to investigate: 1) compliance with the 24-h movement guidelines, and 2) associations between compliance and anthropometry in Finnish preschoolers. METHODS: We utilized DAGIS survey data that were collected in 2015-2016 (N = 864). PA was assessed 24 h/day over 7 days using a waist-worn ActiGraph wGT3X-BT accelerometer. ST and sleep were reported by the parents during the same 7 days. Anthropometry was assessed using body mass index (BMI, kg/m2) and waist circumference (WC, cm). Children were classified as meeting the guidelines if they averaged ≥180 min/day of PA, which consisted of ≥60 min of moderate-to-vigorous intensity; ≤60 min/day of ST; and 10-13 h/day of sleep. In total, 778 children (51% boys, mean age: 4.7 ± 0.9 years) were included in the study. The compliance with meeting the 24-h movement guidelines was calculated for each behavior separately and in combinations. Adjusted linear regression analyses were applied to examine associations of compliance with BMI and WC. RESULTS: Children were physically active on average 390 (±46.2) min/day and spent 86 (±25.5) min/day in moderate-to-vigorous PA. They spent 76 (±37.4) min/day on ST and had on average 10:21 (±0:33) h:min/day of sleep. The compliance rate in meeting all three movement guidelines overall was 24%. The highest compliance rate was found for PA (85%), followed by sleep (76%) and ST (35%). Meeting guidelines separately for PA or sleep, or for both, were associated with lower WC (PA: B = -1.37, p < 0.001; Sleep: B = -0.72, p = 0.009; PA + Sleep: B = -1.03, p < 0.001). In addition, meeting guidelines for sleep or for both PA and sleep were associated with lower BMI (Sleep: B = -0.26, p = 0.027; PA + Sleep: B = -0.30, p = 0.007). There were no significant associations found regarding ST. CONCLUSIONS: Meeting recommendations for PA and sleep may have an important role in supporting a healthy weight status in young children. However, there is still a need to improve compliance with the 24-h movement guidelines, especially for ST.

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 Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Protocol for a Randomized Controlled Trial.

BACKGROUND: Excessive gestational weight gain is common and associated with adverse outcomes both in the short and long term. Although traditional lifestyle-based interventions have shown to mitigate excess gestational weight gain, little is known about whether mobile Health (mHealth) apps can promote healthy weight gain, diet, and physical activity during pregnancy. OBJECTIVE: The primary aim of the HealthyMoms trial is to determine the effectiveness of a smartphone app (HealthyMoms) for mitigating excess gestational weight gain during pregnancy. Secondary aims are to determine the effectiveness of the app on dietary habits, physical activity, body fatness, and glycemia during pregnancy. METHODS: HealthyMoms is a two-arm randomized controlled trial. Women are being recruited at routine visits at the maternity clinics in Linköping, Norrköping and Motala, Sweden. Women are randomized to the control or intervention group (n=150 per group). All women will receive standard care, and women in the intervention group will also receive the HealthyMoms smartphone app. RESULTS: Recruitment of participants to the trial was initiated in October 2017, and 190 women have so far completed the baseline measurement. The baseline measures are estimated to be finalized in December 2019, and the follow-up measures are estimated to be completed in June 2020. CONCLUSIONS: This project will evaluate a novel smartphone app intervention integrated with existing maternity health care. If successful, it has great potential to be implemented nationally in order to promote healthy weight gain and health behaviors during pregnancy. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13011.

The Smart City Active Mobile Phone Intervention (SCAMPI) study to promote physical activity through active transportation in healthy adults: a study protocol for a randomised controlled trial.

BACKGROUND: The global pandemic of physical inactivity represents a considerable public health challenge. Active transportation (i.e., walking or cycling for transport) can contribute to greater total physical activity levels. Mobile phone-based programs can promote behaviour change, but no study has evaluated whether such a program can promote active transportation in adults. This study protocol presents the design and methodology of The Smart City Active Mobile Phone Intervention (SCAMPI), a randomised controlled trial to promote active transportation via a smartphone application (app) with the aim to increase physical activity. METHODS/DESIGN: A two-arm parallel randomised controlled trial will be conducted in Stockholm County, Sweden. Two hundred fifty adults aged 20-65 years will be randomised to either monitoring of active transport via the TRavelVU app (control), or to a 3-month evidence-based behaviour change program to promote active transport and monitoring of active travel via the TRavelVU Plus app (intervention). The primary outcome is moderate-to-vigorous intensity physical activity (MVPA in minutes/day) (ActiGraph wGT3x-BT) measured post intervention. Secondary outcomes include: time spent in active transportation measured via the TRavelVU app, perceptions about active transportation (the Transport and Physical Activity Questionnaire (TPAQ)) and health related quality of life (RAND-36). Assessments are conducted at baseline, after the completed intervention (after 3 months) and 6 months post randomisation. DISCUSSION: SCAMPI will determine the effectiveness of a smartphone app to promote active transportation and physical activity in an adult population. If effective, the app has potential to be a low-cost intervention that can be delivered at scale. TRIAL REGISTRATION: ClinicalTrials.gov NCT03086837 ; 22 March, 2017.

App-technology to increase physical activity among patients with diabetes type 2 - the DiaCert-study, a randomized controlled trial.

BACKGROUND: Physical activity can decrease the risk of complications related to diabetes type 2. Feasible and scalable strategies to implement support for a healthy lifestyle for patients in primary care are needed. The aim of the DiaCert-study is to evaluate a digital healthcare platform and the effect of a 12-week long smartphone-app physical activity intervention aiming at increasing physical activity (primary outcome) and improve levels of HbA1c (glycated hemoglobin), blood lipids, blood pressure, body composition, as well as other lifestyle factors and overall health in patients with diabetes type 2. METHODS/DESIGN: The DiaCert-study is a two-arm, randomized controlled trial that will include 250 patients with diabetes type 2. At baseline, participants are randomized 1:1 to intervention, i.e. use of the smartphone-app, during 12 weeks, or to a control group receiving only standard care. Physical activity and sedentary behavior, is objectively measured using the Actigraph GT3X. Biomarkers including HbA1c and blood lipids are measured in fasting blood samples. Anthropometrics include height, weight, waist circumference and body composition, and a number of lifestyle factors including sleep, diet, self-efficacy, and quality of life, are assessed through an extensive questionnaire. Measurements are made at baseline and at follow-up after 3, 6 and 12 months. DISCUSSION: Using new technology, is one way to bridge the gap between what patients need and what health care can offer. This study evaluates a new digital health care platform and will show if use of a smartphone-app to promote daily steps is an effective and feasible method to increase physical activity and improve clinical markers in patients with diabetes type 2. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03053336 ; 7 Feb, 2017.

Validation of an Online Food Frequency Questionnaire against Doubly Labelled Water and 24 h Dietary Recalls in Pre-School Children.

The development of easy-to-use and accurate methods to assess the intake of energy, foods and nutrients in pre-school children is needed. KidMeal-Q is an online food frequency questionnaire developed for the LifeGene prospective cohort study in Sweden. The aims of this study were to compare: (i) energy intake (EI) obtained using KidMeal-Q to total energy expenditure (TEE) measured via doubly labelled water and (ii) the intake of certain foods measured using KidMeal-Q to intakes acquired by means of 24 h dietary recalls in 38 children aged 5.5 years. The mean EI calculated using KidMeal-Q was statistically different (p < 0.001) from TEE (4670 ± 1430 kJ/24 h and 6070 ± 690 kJ/24 h, respectively). Significant correlations were observed for vegetables, fruit juice and candy between KidMeal-Q and 24 h dietary recalls. Only sweetened beverage consumption was significantly different in mean intake (p < 0.001), as measured by KidMeal-Q and 24 h dietary recalls. In conclusion, KidMeal-Q had a relatively short answering time and comparative validity to other food frequency questionnaires. However, its accuracy needs to be improved before it can be used in studies in pre-school children.

The Tanita SC-240 to Assess Body Composition in Pre-School Children: An Evaluation against the Three Component Model.

Quick, easy-to-use, and valid body composition measurement options for young children are needed. Therefore, we evaluated the ability of the bioelectrical impedance (BIA) device, Tanita SC-240, to measure fat mass (FM), fat free mass (FFM) and body fatness (BF%) in 40 healthy, Swedish 5.5 years old children against the three component model (3C model). Average BF%, FM, and FFM for BIA were: 19.4% ± 3.9%, 4.1 ± 1.9 kg, and 16.4 ± 2.4 kg and were all significantly different (p < 0.001) from corresponding values for the 3C model (25.1% ± 5.5%, 5.3 ± 2.5 kg, and 15.2 ± 2.0 kg). Bland and Altman plots had wide limits of agreement for all body composition variables. Significant correlations ranging from 0.81 to 0.96 (p < 0.001) were found for BF%, FM, and FFM between BIA and the 3C model. When dividing the children into tertiles for BF%, 60% of children were classified correctly by means of BIA. In conclusion, the Tanita SC-240 underestimated BF% in comparison to the 3C model and had wide limits of agreement. Further work is needed in order to find accurate and easy-to-use methods for assessing body composition in pre-school children.