Real-world effectiveness of digital and group-based lifestyle interventions as compared with usual care to reduce type 2 diabetes risk - A stop diabetes pragmatic randomised trial.

Background: No real-world randomised controlled trials (RCTs) have explored the effectiveness of lifestyle interventions based on multiple behaviour change theories and using combined digital and group-based face-to-face delivery to improve risk factors for type 2 diabetes (T2D). Methods: We conducted a one-year, multi-centre, unblinded, pragmatic RCT in primary healthcare using the habit formation, self-determination, and self-regulation theories among 2907 adults aged 18-74 years at increased T2D risk randomised into a digital lifestyle intervention group (DIGI, n = 967), a combined digital and group-based lifestyle intervention group (DIGI+GROUP, n = 971), and a control group receiving usual care (CONTROL, n = 969). We collected data on primary outcomes (diet quality by Healthy Diet Index [HDI], physical activity, body weight, fasting plasma glucose, 2-hour plasma glucose) and secondary outcomes (sedentary time, waist circumference, fasting plasma insulin) using digital questionnaires, clinical examinations, fasting blood tests, and 2-hour oral glucose tolerance tests. Main statistical analyses were performed using linear mixed-effects models adjusted for age, sex, and province. This RCT was registered with ClinicalTrials.gov, NCT03156478. Findings: The 2907 participants assigned were recruited between March 1st, 2017, and February 28th, 2018. Diet quality improved more (3·2 vs. 1·4 HDI points, p<0·001 for difference between groups, p'<0·001 for group*time interaction) and waist circumference tended to decrease more (-1·8 vs. -1·3 cm, p = 0·028, p' = 0·068) in DIGI+GROUP than in CONTROL. Fasting insulin tended to increase in CONTROL but not in DIGI (1·0 vs. 0·0 mU/L, p = 0·033, p' = 0·054) or in DIGI+GROUP (1·0 vs. 0·5 mU/L, p = 0·042, p' = 0·054). Good adherence to DIGI and DIGI+GROUP (≥median of 501 habits/year in DIGI, ≥5 of all 6 sessions in GROUP) was associated with improved diet quality and good adherence to DIGI with increased physical activity and decreased sedentary time. Interpretation: A lifestyle intervention based on multiple behaviour change theories and combined digital and group-based face-to-face delivery improves diet quality and tends to decrease abdominal adiposity and prevent an increase in insulin resistance. Good adherence improves the results of the interventions. Funding: Strategic Research Council at Academy of Finland, Academy of Finland, Novo Nordisk Foundation, and Finnish Diabetes Research foundation.

Users' Experiences With the NoHoW Web-Based Toolkit With Weight and Activity Tracking in Weight Loss Maintenance: Long-term Randomized Controlled Trial.

BACKGROUND: Digital behavior change interventions (DBCIs) offer a promising channel for providing health promotion services. However, user experience largely determines whether they are used, which is a precondition for effectiveness. OBJECTIVE: The primary aim of this study is to evaluate user experiences with the NoHoW Toolkit (TK)-a DBCI that targets weight loss maintenance-over a 12-month period by using a mixed methods approach and to identify the main strengths and weaknesses of the TK and the external factors affecting its adoption. The secondary aim is to objectively describe the measured use of the TK and its association with user experience. METHODS: An 18-month, 2×2 factorial randomized controlled trial was conducted. The trial included 3 intervention arms receiving an 18-week active intervention and a control arm. The user experience of the TK was assessed quantitatively through electronic questionnaires after 1, 3, 6, and 12 months of use. The questionnaires also included open-ended items that were thematically analyzed. Focus group interviews were conducted after 6 months of use and thematically analyzed to gain deeper insight into the user experience. Log files of the TK were used to evaluate the number of visits to the TK, the total duration of time spent in the TK, and information on intervention completion. RESULTS: The usability level of the TK was rated as satisfactory. User acceptance was rated as modest; this declined during the trial in all the arms, as did the objectively measured use of the TK. The most appreciated features were weekly emails, graphs, goal setting, and interactive exercises. The following 4 themes were identified in the qualitative data: engagement with features, decline in use, external factors affecting user experience, and suggestions for improvements. CONCLUSIONS: The long-term user experience of the TK highlighted the need to optimize the technical functioning, appearance, and content of the DBCI before and during the trial, similar to how a commercial app would be optimized. In a trial setting, the users should be made aware of how to use the intervention and what its requirements are, especially when there is more intensive intervention content. TRIAL REGISTRATION: ISRCTN Registry ISRCTN88405328; https://www.isrctn.com/ISRCTN88405328. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-029425.

Multiomics and digital monitoring during lifestyle changes reveal independent dimensions of human biology and health.

We explored opportunities for personalized and predictive health care by collecting serial clinical measurements, health surveys, genomics, proteomics, autoantibodies, metabolomics, and gut microbiome data from 96 individuals who participated in a data-driven health coaching program over a 16-month period with continuous digital monitoring of activity and sleep. We generated a resource of >20,000 biological samples from this study and a compendium of >53 million primary data points for 558,032 distinct features. Multiomics factor analysis revealed distinct and independent molecular factors linked to obesity, diabetes, liver function, cardiovascular disease, inflammation, immunity, exercise, diet, and hormonal effects. For example, ethinyl estradiol, a common oral contraceptive, produced characteristic molecular and physiological effects, including increased levels of inflammation and impact on thyroid, cortisol levels, and pulse, that were distinct from other sources of variability observed in our study. In total, this work illustrates the value of combining deep molecular and digital monitoring of human health. A record of this paper's transparent peer review process is included in the supplemental information.

A Theory- and Evidence-Based Digital Intervention Tool for Weight Loss Maintenance (NoHoW Toolkit): Systematic Development and Refinement Study.

BACKGROUND: Many weight loss programs show short-term effectiveness, but subsequent weight loss maintenance is difficult to achieve. Digital technologies offer a promising means of delivering behavior change approaches at low costs and on a wide scale. The Navigating to a Healthy Weight (NoHoW) project, which was funded by the European Union's Horizon 2020 research and innovation program, aimed to develop, test, and evaluate a digital toolkit designed to promote successful long-term weight management. The toolkit was tested in an 18-month, large-scale, international, 2×2 factorial (motivation and self-regulation vs emotion regulation) randomized controlled trial that was conducted on adults with overweight or obesity who lost ≥5% of their body weight in the preceding 12 months before enrollment into the intervention. OBJECTIVE: This paper aims to describe the development of the NoHoW Toolkit, focusing on the logic models, content, and specifications, as well as the results from user testing. METHODS: The toolkit was developed by using a systematic approach, which included the development of the theory-based logic models, the selection of behavior change techniques, the translation of these techniques into a web-based app (NoHoW Toolkit components), technical development, and the user evaluation and refinement of the toolkit. RESULTS: The toolkit included a set of web-based tools and inputs from digital tracking devices (smart scales and activity trackers) and modules that targeted weight, physical activity, and dietary behaviors. The final toolkit comprised 34 sessions that were distributed through 15 modules and provided active content over a 4-month period. The motivation and self-regulation arm consisted of 8 modules (17 sessions), the emotion regulation arm was presented with 7 modules (17 sessions), and the combined arm received the full toolkit (15 modules; 34 sessions). The sessions included a range of implementations, such as videos, testimonies, and questionnaires. Furthermore, the toolkit contained 5 specific data tiles for monitoring weight, steps, healthy eating, mood, and sleep. CONCLUSIONS: A systematic approach to the development of digital solutions based on theory, evidence, and user testing may significantly contribute to the advancement of the science of behavior change and improve current solutions for sustained weight management. Testing the toolkit by using a 2×2 design provided a unique opportunity to examine the effect of motivation and self-regulation and emotion regulation separately, as well as the effect of their interaction in weight loss maintenance.

Comparison of Communication Channels for Large-Scale Type 2 Diabetes Risk Screening and Intervention Recruitment: Empirical Study.

BACKGROUND: Clinical trials have shown that type 2 diabetes (T2D) is preventable through lifestyle interventions targeting high-risk people. Nevertheless, large-scale implementation of risk identification followed by preventive interventions has proven to be challenging. Specifically, recruitment of participants into preventive interventions is an important but often overlooked part of the intervention. OBJECTIVE: This study aims to compare the reach and yield of different communication channels to engage people at increased risk of T2D to fill in a digital screening questionnaire, with emphasis on reaching those at most risk. The participants expressing their willingness to participate is the final step in the risk screening test, and we aim to determine which channels had the most participants reach this step. METHODS: We established a stepwise web-based T2D risk screening tool with automated feedback according to the T2D risk level and, for those who were eligible, an invitation to participate in the StopDia prevention intervention study conducted in a primary health care setting. The risk estimate was based on the Finnish Diabetes Risk Score; history of repeatedly measured high blood glucose concentration; or, among women, previous gestational diabetes. We used several channels to invite people to the StopDia web-based screening tool, and respondents were classified into 11 categories based on the channel through which they reported having learned about StopDia. The demographics of respondents reached via different communication channels were compared using variance analysis. Logistic regression was used to study the respondents' likelihood of progressing through risk screening steps. RESULTS: A total of 33,399 persons started filling the StopDia screening tool. Of these, 86.13% (28,768/33,399) completed the test and named at least one communication channel as the source of information about StopDia. Altogether, 26,167 persons filled in sufficient information to obtain risk estimates. Of them, 53.22% (13,925/26,167) were at increased risk, 30.06% (7866/26,167) were men, and 39.77% (10,136/25,485) had low or middle education levels. Most frequently mentioned channels were workplace (n=6817), social media or the internet (n=6712), and newspapers (n=4784). The proportion of individuals at increased risk was highest among those reached via community pharmacies (415/608, 68.3%) and health care (1631/2535, 64.33%). The communication channel reaching the largest percentage of interested and eligible men (1353/3979, 34%) was relatives or friends. Health care (578/1069, 54.07%) and radio or television (225/487, 46.2%) accounted for the largest proportion of people with lower education. CONCLUSIONS: Communication channels reaching a large number of people, such as social media and newspapers, were the most effective channels for identifying at-risk people. Personalized approaches increased the engagement of men and less-educated people. Community pharmacies and health care services reached people with a particularly high T2D risk. Thus, communication and recruitment channels should be selected and modified based on the intended target group. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-6574-y.

Sleep-time physiological recovery is associated with eating habits in distressed working-age Finns with overweight: secondary analysis of a randomised controlled trial.

BACKGROUND: Association of physiological recovery with nutrition has scarcely been studied. We investigated whether physiological recovery during sleep relates to eating habits, i.e., eating behaviour and diet quality. METHODS: Cross-sectional baseline analysis of psychologically distressed adults with overweight (N = 252) participating in a lifestyle intervention study in three Finnish cities. Recovery measures were based on sleep-time heart rate variability (HRV) measured for 3 consecutive nights. Measures derived from HRV were 1) RMSSD (Root Mean Square of the Successive Differences) indicating the parasympathetic activation of the autonomic nervous system and 2) Stress Balance (SB) indicating the temporal ratio of recovery to stress. Eating behaviour was measured with questionnaires (Intuitive Eating Scale, Three-Factor Eating Questionnaire, Health and Taste Attitude Scales, ecSatter Inventory™). Diet quality was quantified using questionnaires (Index of Diet Quality, Alcohol Use Disorders Identification Test Consumption) and 48-h dietary recall. RESULTS: Participants with best RMSSD reported less intuitive eating (p = 0.019) and less eating for physical rather than emotional reasons (p = 0.010) compared to those with poorest RMSSD; participants with good SB reported less unconditional permission to eat (p = 0.008), higher fibre intake (p = 0.028), higher diet quality (p = 0.001), and lower alcohol consumption (p < 0.001) compared to those with poor SB, although effect sizes were small. In subgroup analyses among participants who reported working regular daytime hours (n = 216), only the associations of SB with diet quality and alcohol consumption remained significant. CONCLUSIONS: Better nocturnal recovery showed associations with better diet quality, lower alcohol consumption and possibly lower intuitive eating. In future lifestyle interventions and clinical practice, it is important to acknowledge sleep-time recovery as one possible factor linked with eating habits. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01738256 , Registered 17 August 2012.

Evidence-Based Digital Tools for Weight Loss Maintenance: The NoHoW Project.

BACKGROUND: Effective interventions and commercial programmes for weight loss (WL) are widely available, but most people regain weight. Few effective WL maintenance (WLM) solutions exist. The most promising evidence-based behaviour change techniques for WLM are self-monitoring, goal setting, action planning and control, building self-efficacy, and techniques that promote autonomous motivation (e.g., provide choice). Stress management and emotion regulation techniques show potential for prevention of relapse and weight regain. Digital technologies (including networked-wireless tracking technologies, online tools and smartphone apps, multimedia resources, and internet-based support) offer attractive tools for teaching and supporting long-term behaviour change techniques. However, many digital offerings for weight management tend not to include evidence-based content and the evidence base is still limited. The Project: First, the project examined why, when, and how many European citizens make WL and WLM attempts and how successful they are. Second, the project employed the most up-to-date behavioural science research to develop a digital toolkit for WLM based on 2 key conditions, i.e., self-management (self-regulation and motivation) of behaviour and self-management of emotional responses for WLM. Then, the NoHoW trial tested the efficacy of this digital toolkit in adults who achieved clinically significant (≥5%) WL in the previous 12 months (initial BMI ≥25). The primary outcome was change in weight (kg) at 12 months from baseline. Secondary outcomes included biological, psychological, and behavioural moderators and mediators of long-term energy balance (EB) behaviours, and user experience, acceptability, and cost-effectiveness. IMPACT: The project will directly feed results from studies on European consumer behaviour, design and evaluation of digital toolkits self-management of EB behaviours into development of new products and services for WLM and digital health. The project has developed a framework and digital architecture for interventions in the context of EB tracking and will generate results that will help inform the next generation of personalised interventions for effective self-management of weight and health.

Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial.

BACKGROUND: Type 2 diabetes can be prevented through lifestyle changes, but sustainable and scalable lifestyle interventions are still lacking. Habit-based approaches offer an opportunity to induce long-term behavior changes. OBJECTIVE: The purposes of this study were to describe an internet-based lifestyle intervention for people at risk for type 2 diabetes targeted to support formation of healthy habits and explore its user engagement during the first 6 months of a randomized controlled trial (RCT). METHODS: The app provides an online store that offers more than 400 simple and contextualized habit-forming behavioral suggestions triggered by daily life activities. Users can browse, inspect, and select them; report their performances; and reflect on their own activities. Users can also get reminders, information on other users' activities, and information on the prevention of type 2 diabetes. An unblended parallel RCT was carried out to evaluate the effectiveness of the app in comparison with routine care. User engagement is reported for the first 6 months of the trial based on the use log data of the participants, who were 18- to 70-year-old community-dwelling adults at an increased risk of type 2 diabetes. RESULTS: Of 3271 participants recruited online, 2909 were eligible to participate in the RCT. Participants were randomized using a computerized randomization system to the control group (n=971), internet-based intervention (digital, n=967), and internet-based intervention with face-to-face group coaching (F2F+digital, n=971). Mean age of control group participants was 55.0 years, digital group 55.2 years, and F2F+digital 55.2 years. The majority of participants were female, 81.1% (787/971) in the control group, 78.3% (757/967) in the digital group, and 80.7% (784/971) in the F2F+digital group. Of the participants allocated to the digital and F2F+digital groups, 99.53% (1929/1938) logged in to the app at least once, 98.55% (1901/1938) selected at least one habit, and 95.13% (1835/1938) reported at least one habit performance. The app was mostly used on a weekly basis. During the first 6 months, the number of active users on a weekly level varied from 93.05% (1795/1929) on week 1 to 51.79% (999/1929) on week 26. The daily use activity was not as high. The digital and F2F+digital groups used the app on a median of 23.0 and 24.5 days and for 79.4 and 85.1 minutes total duration, respectively. A total of 1,089,555 habit performances were reported during the first 6 months. There were no significant differences in the use metrics between the groups with regard to cumulative use metrics. CONCLUSIONS: Results demonstrate that internet-based lifestyle interventions can be delivered to large groups including community-dwelling middle-aged and older adults, many with limited experience in digital app use, without additional user training. This intermediate analysis of use behavior showed relatively good engagement, with the percentage of active weekly users remaining over 50% at 6 months. However, we do not yet know if the weekly engagement was enough to change the lifestyles of the participants. TRIAL REGISTRATION: ClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478.

The Effects of Acceptance and Commitment Therapy (ACT) Intervention on Inflammation and Stress Biomarkers: a Randomized Controlled Trial.

BACKGROUND: Psychological processes can be manifested in physiological health. We investigated whether acceptance and commitment therapy (ACT), targeted on psychological flexibility (PF), influences inflammation and stress biomarkers among working-age adults with psychological distress and overweight/obesity. METHOD: Participants were randomized into three parallel groups: (1) ACT-based face-to-face (n = 65; six group sessions led by a psychologist), (2) ACT-based mobile (n = 73; one group session and mobile app), and (3) control (n = 66; only the measurements). Systemic inflammation and stress markers were analyzed at baseline, at 10 weeks after the baseline (post-intervention), and at 36 weeks after the baseline (follow-up). General PF and weight-related PF were measured with questionnaires (Acceptance and Action Questionnaire, Acceptance and Action Questionnaire for Weight-Related Difficulties). RESULTS: A group × time interaction (p = .012) was detected in the high-sensitivity C-reactive protein (hsCRP) level but not in other inflammation and stress biomarkers. hsCRP decreased significantly in the face-to-face group from week 0 to week 36, and at week 36, hsCRP was lower among the participants in the face-to-face group than in the mobile group (p = .035, post hoc test). Age and sex were stronger predictors of biomarker levels at follow-up than the post-intervention PF. CONCLUSION: The results suggest that ACT delivered in group sessions may exert beneficial effects on low-grade systemic inflammation. More research is needed on how to best apply psychological interventions for the health of both mind and body among people with overweight/obesity and psychological distress. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01738256, Registered 17 August, 2012.

Health timeline: an insight-based study of a timeline visualization of clinical data.

BACKGROUND: The increasing complexity and volume of clinical data poses a challenge in the decision-making process. Data visualizations can assist in this process by speeding up the time required to analyze and understand clinical data. Even though empirical experiments show that visualizations facilitate clinical data understanding, a consistent method to assess their effectiveness is still missing. METHODS: The insight-based methodology determines the quality of insights a user acquires from the visualization. Insights receive a value from one to five points based on a domain-specific criteria. Five professional psychiatrists took part in the study using real de-identified clinical data spanning 4 years of medical history. RESULTS: A total of 50 assessments were transcribed and analyzed. Comparing a total of 558 insights using Health Timeline and 576 without, the mean value using the Timeline (1.7) was higher than without (1.26; p<0.01), similarly the cumulative value with the Timeline (11.87) was higher than without (10.96: p<0.01). The average time required to formulate the first insight with the Timeline was higher (13.16 s) than without (7 s; p<0.01). Seven insights achieved the highest possible value using Health Timeline while none were obtained without it. CONCLUSIONS: The Health Timeline effectively improved understanding of clinical data and helped participants recognize complex patterns from the data. By applying the insight-based methodology, the effectiveness of the Health Timeline was quantified, documented and demonstrated. As an outcome of this exercise, we propose the use of such methodologies to measure the effectiveness of visualizations that assist the clinical decision-making process.

Exploring Associations Between the Self-Reported Values, Well-Being, and Health Behaviors of Finnish Citizens: Cross-Sectional Analysis of More Than 100,000 Web-Survey Responses.

BACKGROUND: Understanding the relationship between personal values, well-being, and health-related behavior could facilitate the development of engaging, effective digital interventions for promoting well-being and the healthy lifestyles of citizens. Although the associations between well-being and values have been quite extensively studied, the knowledge about the relationship between health behaviors and values is less comprehensive. OBJECTIVE: The aim of this study was to assess retrospectively the associations between self-reported values and commitment to values combined with self-reported well-being and health behaviors from a large cross-sectional dataset. METHODS: We analyzed 101,130 anonymous responses (mean age 44.78 years [SD 13.82]; 78.88%, 79,770/101,130 women) to a Finnish Web survey, which were collected as part of a national health promotion campaign. The data regarding personal values were unstructured, and the self-reported value items were classified into value types based on the Schwartz value theory and by applying principal component analysis. Logistic and multiple linear regression were used to explore the associations of value types and commitment to values with well-being factors (happiness, communal social activity, work, and family-related distress) and health behaviors (exercise, eating, smoking, alcohol consumption, and sleep). RESULTS: Commitment to personal values was positively related to happiness (part r2=0.28), communal social activity (part r2=0.09), and regular exercise (part r2=0.06; P<.001 for all). Health, Power (social status and dominance), and Mental balance (self-acceptance) values had the most extensive associations with health behaviors. Regular exercise, healthy eating, and nonsmoking increased the odds of valuing Health by 71.7%, 26.8%, and 40.0%, respectively (P<.001 for all). Smoking, unhealthy eating, irregular exercise, and increased alcohol consumption increased the odds of reporting Power values by 27.80%, 27.78%, 24.66%, and 17.35%, respectively (P<.001 for all). Smoking, unhealthy eating, and irregular exercise increased the odds of reporting Mental balance values by 20.79%, 16.67%, and 15.37%, respectively (P<.001 for all). In addition, lower happiness levels increased the odds of reporting Mental balance and Power values by 24.12% and 20.69%, respectively (P<.001 for all). CONCLUSIONS: The findings suggest that commitment to values is positively associated with happiness and highlight various, also previously unexplored, associations between values and health behaviors.

Digitally supported program for type 2 diabetes risk identification and risk reduction in real-world setting: protocol for the StopDia model and randomized controlled trial.

BACKGROUND: The StopDia study is based on the convincing scientific evidence that type 2 diabetes (T2D) and its comorbidities can be prevented by a healthy lifestyle. The need for additional research is based on the fact that the attempts to translate scientific evidence into actions in the real-world health care have not led to permanent and cost-effective models to prevent T2D. The specific aims of the StopDia study following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework are to 1) improve the Reach of individuals at increased risk, 2) evaluate the Effectiveness and cost-effectiveness of the digital lifestyle intervention and the digital and face-to-face group lifestyle intervention in comparison to routine care in a randomized controlled trial (RCT), and 3) evaluate the Adoption and Implementation of the StopDia model by the participants and the health care organizations at society level. Finally, we will address the Maintenance of the lifestyle changes at participant level and that of the program at organisatory level after the RCT. METHODS: The StopDia study is carried out in the primary health care system as part of the routine actions of three provinces in Finland, including Northern Savo, Southern Carelia, and Päijät-Häme. We estimate that one fifth of adults aged 18-70 years living in these areas are at increased risk of T2D. We recruit the participants using the StopDia Digital Screening Tool, including questions from the Finnish Diabetes Risk Score (FINDRISC). About 3000 individuals at increased risk of T2D (FINDRISC ≥12 or a history of gestational diabetes, impaired fasting glucose, or impaired glucose tolerance) participate in the one-year randomized controlled trial. We monitor lifestyle factors using the StopDia Digital Questionnaire and metabolism using laboratory tests performed as part of routine actions in the health care system. DISCUSSION: Sustainable and scalable models are needed to reach and identify individuals at increased risk of T2D and to deliver personalized and effective lifestyle interventions. With the StopDia study we aim to answer these challenges in a scientific project that is fully digitally integrated into the routine health care. TRIAL REGISTRATION: ClinicalTials.gov . Identifier: NCT03156478 . Date of registration 17.5.2017.

Citizen-Centric Web-Based Health Profiling Service: A Service Concept and a Profiling Method.

Personalization of health interventions has been shown to increase their effectiveness. In digital services, user profiles enable this personalization. We introduce a web-based user profiling service, where citizens can 1) create various personal profiles, specific to certain health topics, by providing their personal data, 2) get summarized feedback on their health and behavioral determinants regarding each profile, and 3) share their profiles with health service providers. As part of the service, we define a profiling method that identifies the health needs and behavioral determinants of citizens, and highlights their most potential behavior change targets. The novelty in the service arises from allowing citizens to govern their health data, quantifying automatically various behavioral determinants, and summarizing aggregated knowledge efficiently via simple visualizations. The service aims to evoke personal awareness about behavior change needs and the factors influencing behavior, enable health service providers to develop and offer highly personalized, automated interventions, and facilitate time-efficient and transparent decision-making of health professionals. According to a preliminary concept evaluation with citizens (N=29), the presented profile feedback was perceived as interesting and intuitive.

Correlation between symptoms and functioning in psychiatric patients and temporal patterns of medication refills derived from pharmacy prescription claims.

OBJECTIVES:: Pharmacy dispensing claims data provide longitudinal records of prescriptions and refill events. Previous studies in psychiatric patients have utilised these data to derive indicators of medication adherence based on information regarding the amount of medication supplied and its dosage. An alternative approach was developed in which the regularity of medication refill events was analysed as a potential indicator of psychiatric patient symptoms and functioning. METHODS:: A method to quantify the regularity of medication refills was developed and subsequently used to investigate how the resulting regularity index (RI), derived from retrospective prescription refill records, correlated with symptomatic and functional assessments of 89 psychiatric patients after adjusting for covariates. RESULTS:: A two-step hierarchical regression model indicated that variances explained by prior hospitalisation and the RI were significant for patient scores on the Kessler 10 Psychological Distress Scale (K10), standard beta value 0.22, p < 0.05, for the SF-12 MC, standard beta value -0.31, p < 0.01, and the Work and Social Adjustment Scale (WSAS), standard beta value 0.31, p < 0.01. CONCLUSIONS:: This method to quantify the regularity of medication refills using prescription supply date alone may provide valuable information about patients' symptoms and functioning.

The effects of acceptance and commitment therapy on eating behavior and diet delivered through face-to-face contact and a mobile app: a randomized controlled trial.

BACKGROUND: Internal motivation and good psychological capabilities are important factors in successful eating-related behavior change. Thus, we investigated whether general acceptance and commitment therapy (ACT) affects reported eating behavior and diet quality and whether baseline perceived stress moderates the intervention effects. METHODS: Secondary analysis of unblinded randomized controlled trial in three Finnish cities. Working-aged adults with psychological distress and overweight or obesity in three parallel groups: (1) ACT-based Face-to-face (n = 70; six group sessions led by a psychologist), (2) ACT-based Mobile (n = 78; one group session and mobile app), and (3) Control (n = 71; only the measurements). At baseline, the participants' (n = 219, 85% females) mean body mass index was 31.3 kg/m2 (SD = 2.9), and mean age was 49.5 years (SD = 7.4). The measurements conducted before the 8-week intervention period (baseline), 10 weeks after the baseline (post-intervention), and 36 weeks after the baseline (follow-up) included clinical measurements, questionnaires of eating behavior (IES-1, TFEQ-R18, HTAS, ecSI 2.0, REBS), diet quality (IDQ), alcohol consumption (AUDIT-C), perceived stress (PSS), and 48-h dietary recall. Hierarchical linear modeling (Wald test) was used to analyze the differences in changes between groups. RESULTS: Group x time interactions showed that the subcomponent of intuitive eating (IES-1), i.e., Eating for physical rather than emotional reasons, increased in both ACT-based groups (p = .019); the subcomponent of TFEQ-R18, i.e., Uncontrolled eating, decreased in the Face-to-face group (p = .020); the subcomponent of health and taste attitudes (HTAS), i.e., Using food as a reward, decreased in the Mobile group (p = .048); and both subcomponent of eating competence (ecSI 2.0), i.e., Food acceptance (p = .048), and two subcomponents of regulation of eating behavior (REBS), i.e., Integrated and Identified regulation (p = .003, p = .023, respectively), increased in the Face-to-face group. Baseline perceived stress did not moderate effects on these particular features of eating behavior from baseline to follow-up. No statistically significant effects were found for dietary measures. CONCLUSIONS: ACT-based interventions, delivered in group sessions or by mobile app, showed beneficial effects on reported eating behavior. Beneficial effects on eating behavior were, however, not accompanied by parallel changes in diet, which suggests that ACT-based interventions should include nutritional counseling if changes in diet are targeted. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT01738256 ), registered 17 August, 2012.

Psychological flexibility mediates change in intuitive eating regulation in acceptance and commitment therapy interventions.

OBJECTIVE: Despite the promising results related to intuitive eating, few studies have attempted to explain the processes encouraging this adaptive eating behaviour. The focus of the present study was on exploring mechanisms of change in intuitive eating and weight in acceptance and commitment therapy (ACT) interventions. Mediation provides important information regarding the treatment processes and theoretical models related to specific treatment approaches. The study investigates whether psychological flexibility, mindfulness skills and sense of coherence mediated the interventions' effect on intuitive eating and weight. DESIGN: Secondary analysis of a randomized control trial. Mediation analysis compared two ACT interventions - face-to-face (in a group) and mobile (individually) - with a control group using a latent difference score model. Settings Data were collected in three Finnish towns. SUBJECTS: The participants were overweight or obese (n 219), reporting symptoms of perceived stress. RESULTS: The effect of the interventions on participants' (i) BMI, (ii) intuitive eating and its subscales, (iii) eating for physical rather than emotional reasons and (iv) reliance on internal hunger and satiety cues was mediated by changes in weight-related psychological flexibility in both ACT groups. CONCLUSIONS: These findings suggest that ACT interventions aiming for lifestyle changes mediate the intervention effects through the enhanced ability to continue with valued activities even when confronted with negative emotions and thoughts related to weight.

Accelerometry-based assessment and detection of early signs of balance deficits.

Falls are the cause for more than half of the injury-related hospitalizations among older people. Accurate assessment of individuals' fall risk could enable targeted interventions to reduce the risk. This paper presents a novel method for using wearable accelerometers to detect early signs of deficits in balance from gait. Gait acceleration data were analyzed from 35 healthy female participants (73.86±5.40 years). The data were collected with waist-mounted accelerometer and the participants performed three supervised balance tests: Berg Balance Scale (BBS), Timed-Up-and-Go (TUG) and 4m walk. The follow-up tests with the same protocol were performed after one year. Altogether 43 features were extracted from the accelerometer signals. Sequential forward floating selection and ten-fold cross-validation were applied to determine models for 1) estimating the outcomes of BBS, TUG and 4m walk tests and 2) predicting decline in balance during one-year follow-up indicated as decline in BBS total score and one leg stance. Normalized root-mean-square errors (RMSE) of the assessment scale result estimates were 0.28 for BBS score, 0.18 for TUG time, and 0.22 for 4m walk test. Area under curve (AUC) was 0.78 for predicting decline in BBS total score and 0.82 for one leg stance, respectively. The results suggest that the gait features can be used to estimate the result of a clinical balance assessment scale and predict decline in balance. A simple walk test with wearable monitoring could be applicable as an initial screening tool to identify people with early signs of balance deficits.

Usage and Dose Response of a Mobile Acceptance and Commitment Therapy App: Secondary Analysis of the Intervention Arm of a Randomized Controlled Trial.

BACKGROUND: Mobile phone apps offer a promising medium to deliver psychological interventions. A mobile app based on Acceptance and Commitment Therapy (ACT) was developed and studied in a randomized controlled trial (RCT). OBJECTIVE: To study usage metrics of a mobile ACT intervention and dose-response relationship between usage and improvement in psychological flexibility. METHODS: An RCT was conducted to investigate the effectiveness of different lifestyle interventions for overweight people with psychological stress. This paper presents a secondary analysis of the group that received an 8-week mobile ACT intervention. Most of the analyzed 74 participants were female (n=64, 86%). Their median age was 49.6 (interquartile range, IQR 45.4-55.3) years and their mean level of psychological flexibility, measured with the Acceptance and Action Questionnaire II, was 20.4 (95% confidence interval 18.3-22.5). Several usage metrics describing the intensity of use, usage of content, and ways of use were calculated. Linear regression analyses were performed to study the dose-response relationship between usage and the change in psychological flexibility and to identify the usage metrics with strongest association with improvement. Binary logistic regression analyses were further used to assess the role of usage metrics between those who showed improvement in psychological flexibility and those who did not. In addition, associations between usage and baseline participant characteristics were studied. RESULTS: The median number of usage sessions was 21 (IQR 11.8-35), the number of usage days was 15 (IQR 9.0-24), and the number of usage weeks was 7.0 (IQR 4.0-8.0). The participants used the mobile app for a median duration of 4.7 (IQR 3.2-7.2) hours and performed a median of 63 (IQR 46-98) exercises. There was a dose-response relationship between usage and the change in psychological flexibility. The strongest associations with psychological flexibility (results adjusted with gender, age, and baseline psychological variables) were found for lower usage of Self as context related exercises (B=0.22, P=.001) and higher intensity of use, described by the number of usage sessions (B=-0.10, P=.01), usage days (B=-0.17, P=.008), and usage weeks (B=-0.73, P=.02), the number of exercises performed (B=-0.02, P=.03), and the total duration of use (B=-0.30, P=.04). Also, higher usage of Acceptance related exercises (B=-0.18, P=.04) was associated with improvement. Active usage was associated with female gender, older age, and not owning a smart mobile phone before the study. CONCLUSIONS: The results indicated that active usage of a mobile ACT intervention was associated with improved psychological flexibility. Usage metrics describing intensity of use as well as two metrics related to the usage of content were found to be most strongly associated with improvement. TRIAL REGISTRATION: ClinicalTrials.gov NCT01738256; https://clinicaltrials.gov/ct2/show/NCT01738256 (Archived by WebCite at http://www.webcitation.org/6iTePjPLL).

Process and Effects Evaluation of a Digital Mental Health Intervention Targeted at Improving Occupational Well-Being: Lessons From an Intervention Study With Failed Adoption.

BACKGROUND: Digital interventions have the potential to serve as cost-effective ways to manage occupational stress and well-being. However, little is known about the adoption of individual-level digital interventions at organizations. OBJECTIVES: The aim of this paper is to study the effects of an unguided digital mental health intervention in occupational well-being and the factors that influence the adoption of the intervention. METHODS: The intervention was based on acceptance and commitment therapy (ACT) and its aim was to teach skills for stress management and mental well-being. It was delivered via a mobile and a Web-based app that were offered to employees of two information and communication technology (ICT) companies. The primary outcome measures were perceived stress and work engagement, measured by a 1-item stress questionnaire (Stress) and the Utrecht Work Engagement Scale (UWES-9). The intervention process was evaluated regarding the change mechanisms and intervention stages using mixed methods. The initial interviews were conducted face-to-face with human resource managers (n=2) of both companies in August 2013. The participants were recruited via information sessions and email invitations. The intervention period took place between November 2013 and March 2014. The participants were asked to complete online questionnaires at baseline, two months, and four months after the baseline measurement. The final phone interviews for the volunteer participants (n=17) and the human resource managers (n=2) were conducted in April to May 2014, five months after the baseline. RESULTS: Of all the employees, only 27 (8.1%, 27/332) took the app into use, with a mean use of 4.8 (SD 4.7) different days. In the beginning, well-being was on good level in both companies and no significant changes in well-being were observed. The activities of the intervention process failed to integrate the intervention into everyday activities at the workplace. Those who took the app into use experienced many benefits such as relief in stressful situations. The app was perceived as a toolkit for personal well-being that gives concrete instructions on how mindfulness can be practiced. However, many barriers to participate in the intervention were identified at the individual level, such as lack of time, lack of perceived need, and lack of perceived benefits. CONCLUSIONS: The findings suggest that neither the setting nor the approach used in this study were successful in adopting new digital interventions at the target organizations. Barriers were faced at both the organizational as well as the individual level. At the organizational level, top management needs to be involved in the intervention planning for fitting into the organization policies, the existing technology infrastructure, and also targeting the organizational goals. At the individual level, concretizing the benefits of the preventive intervention and arranging time for app use at the workplace are likely to increase adoption.

High perceived stress is associated with unfavorable eating behavior in overweight and obese Finns of working age.

Stress-related eating may be a potential factor in the obesity epidemic. Rather little is known about how stress associates with eating behavior and food intake in overweight individuals in a free-living situation. Thus, the present study aims to investigate this question in psychologically distressed overweight and obese working-aged Finns. The study is a cross-sectional baseline analysis of a randomized controlled trial. Of the 339 study participants, those with all the needed data available (n = 297, 84% females) were included. The mean age was 48.9 y (SD = 7.6) and mean body mass index 31.3 kg/m(2) (SD = 3.0). Perceived stress and eating behavior were assessed by self-reported questionnaires Perceived Stress Scale (PSS), Intuitive Eating Scale, the Three-Factor Eating Questionnaire, Health and Taste Attitude Scales and ecSatter Inventory. Diet and alcohol consumption were assessed by 48-h dietary recall, Index of Diet Quality, and AUDIT-C. Individuals reporting most perceived stress (i.e. in the highest PSS tertile) had less intuitive eating, more uncontrolled eating, and more emotional eating compared to those reporting less perceived stress (p < 0.05). Moreover, individuals in the highest PSS tertile reported less cognitive restraint and less eating competence than those in the lowest tertile (p < 0.05). Intake of whole grain products was the lowest among those in the highest PSS tertile (p < 0.05). Otherwise the quality of diet and alcohol consumption did not differ among the PSS tertiles. In conclusion, high perceived stress was associated with the features of eating behavior that could in turn contribute to difficulties in weight management. Stress-related way of eating could thus form a potential risk factor for obesity. More research is needed to develop efficient methods for clinicians to assist in handling stress-related eating in the treatment of obese people.