Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention.

BACKGROUND: Mental health issues are common among patients with chronic physical conditions, affecting approximately one in five patients. Poor mental health is associated with worse disease outcomes and increased mortality. Problem-solving therapy (PST) may be a suitable treatment for targeting poor mental health in these patients. This study protocol describes a randomised controlled trial of the Healthy Mind intervention, a general practice-based intervention offering PST to patients with type 2 diabetes and/or ischaemic heart disease and poor mental well-being. METHODS: A stepped-wedge cluster-randomised controlled trial with 1-year follow-up will be conducted in Danish general practice. At the annual chronic care consultation, patients with type 2 diabetes and/or chronic ischaemic heart disease will be screened for poor mental well-being. Patients in the control group will be offered usual care while patients in the intervention group will be offered treatment with PST provided by general practitioners (GPs) or general practice staff, such as nurses, who will undergo a 2-day PST course before transitioning from the control to the intervention group. The primary outcome is change in depressive symptoms after 6 and 12 months. Secondary outcomes include change in mental well-being, anxiety, and diabetes distress (patients with type 2 diabetes) after 6 and 12 months as well as change in total cholesterol levels, low-density lipoprotein (LDL) levels, and blood glucose levels (patients with diabetes) after 12 months. Process outcomes include measures of implementation and mechanisms of impact. We aim to include a total of 188 patients, corresponding to approximately 14 average-sized general practices. DISCUSSION: The Healthy Mind trial investigates the impact of PST treatment for patients with chronic disease and poor mental well-being in general practice. This will be the first randomised controlled trial determining the effect of PST treatment for patients with chronic diseases in general practice. The results of this study will provide relevant insights to aid GPs, and general practice staff manage patients with poor mental well-being. TRIAL REGISTRATION: ClinicalTrials.gov NCT05611112. Registered on October 28, 2022.

The effect of exercise training and motivational counselling on physical activity behaviour and psychosocial factors in pregnant women: secondary analyses of the FitMum randomised controlled trial investigating prenatal physical activity.

BACKGROUND: A physically active lifestyle is beneficial during pregnancy. However, little is known about physical activity (PA) behaviour and psychosocial factors in women during and after pregnancy. This study examined exercise behavioural regulation, exercise self-efficacy, health-related quality of life, sickness absence and musculoskeletal pain in pregnant women offered either structured supervised exercise training, motivational counselling on PA, or standard prenatal care in the FitMum randomised controlled trial. METHODS: Two hundred and eighteen healthy inactive pregnant women were randomised to structured supervised exercise training (n = 87), motivational counselling on PA (n = 86) or standard prenatal care (n = 45). The women answered the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2), the Pregnancy Exercise Self-Efficacy Scale (P-ESES-DK) and the Short Form 36 Health Survey Questionnaire (SF-36) at baseline (gestational age (GA) of max 15 weeks), GA 28 and 34 weeks, and one year after delivery. Sickness absence and low back and/or pelvic girdle pain were likewise reported in questionnaires at baseline and GA 28 weeks. RESULTS: Participants offered structured supervised exercise training or motivational counselling on PA had higher autonomous motivation for exercise during pregnancy compared with participants receiving standard prenatal care (e.g., difference in intrinsic regulation at GA 28 weeks, structured supervised exercise training vs. standard prenatal care: mean difference in score 0.39 [0.16; 0.64], p < 0.001). Participants offered structured supervised exercise training also had higher exercise self-efficacy during pregnancy (e.g., GA 28 weeks, structured supervised exercise training vs. standard prenatal care: mean difference in score 6.97 [2.05; 12.02], p = 0.005). All participants reported high exercise self-efficacy at baseline and medium exercise self-efficacy during pregnancy and one year after delivery. No differences were found between groups in health-related quality of life, sickness absence or low back and/or pelvic girdle pain during pregnancy. No group differences were found one year after delivery. CONCLUSION: Structured supervised exercise training and motivational counselling on PA had important effects on autonomous exercise motivation during pregnancy. Exercise self-efficacy was also increased with structured supervised exercise training compared to standard prenatal care. No group differences in health-related quality of life, sickness absence, or pain were found during and after pregnancy. No effects were found one year post-delivery after intervention cessation. TRIAL REGISTRATION: The study was approved by the Danish National Committee on Health Research Ethics (#H-18011067) and the Danish Data Protection Agency (#P-2019-512). The study adheres to the principles of the Helsinki declaration. Written informed consent was obtained at inclusion.

"I always felt like I wasn't supposed to be there". An international qualitative study of fathers' engagement in family healthcare during transition to fatherhood.

OBJECTIVE: Engagement of fathers in family health services confers benefits for the health and wellbeing of the whole family. The childbirth continuum is traditionally considered a feminine event, however, commensurate with the changing paradigm of gender equity in family healthcare worldwide, the role of fathers is in transformation. The aim of the study is to explore father's perceptions and experiences of healthcare engagement during pregnancy and early infant care. DESIGN: Qualitative free-text questions were embedded in a large multi-country, cross-sectional survey, to explored fathers' attendance, participation, and experience of health care during appointments with their pregnant partner and/or baby. SETTING AND PARTICIPANTS: Expectant and new fathers were recruited through Prolific®, an international paid online survey platform. FINDINGS: Qualitative responses (n=889) were provided by fathers from 28 countries, with experiences of a range of contexts and models of care; 46.8% of whose partners were pregnant and 53.2% had given birth since 2020. The findings suggest that although most fathers wanted to attend and participate in maternity and early parenting-related healthcare, multiple barriers were identified at the individual father, organisational context, and societal levels. Fathers reported negative social factors such as gender bias and restrictive gender norms as barriers to their healthcare engagement. In contrast, factors that enabled fathers to overcome barriers included the fathers' feelings of confidence in their partner's autonomy and decision-making skills, trusted professional relationships with clinicians, and clinicians with good interpersonal skills. KEY CONCLUSIONS: Multiple barriers restrict the participation of fathers in healthcare for childbearing and early parenting. Knowledge of these barriers can inform healthcare redesign to include more successful engagement strategies for fathers, to benefit fathers, mothers, and infants alike. IMPLICATIONS FOR PRACTICE: Health professionals consulting with the mother, father and infant triad are ideally placed to address the healthcare needs of both parents. Early engagement of fathers in family health care by use of inclusive interpersonal skills and the development of a trusted relationship has potential to improve paternal mental health, and may be associated with benefits for the health, wellbeing and safety of the whole family.

Managing mental health in chronic care in general practice: a feasibility study of the Healthy Mind intervention.

BACKGROUND AND OBJECTIVE: Mental health issues are common among patients with chronic physical conditions. This study aims to evaluate the feasibility of the Healthy Mind intervention, a general practice-based programme that provides problem-solving therapy (PST) to patients with poor mental well-being and type 2 diabetes (T2D) and/or ischaemic heart disease (IHD). DESIGN AND SETTING: A one-arm feasibility study was conducted in three general practices in the Central Denmark Region. INTERVENTION: Eight healthcare providers from the included general practices underwent a two-day course to acquire PST skills. Screening for poor mental health was carried out at the annual chronic care consultation for T2D or IHD, and PST sessions were offered to patients on indication of poor mental health. Nine patients received PST. METHODS: Semi-structured interviews with eight healthcare providers and six patients were conducted. Data were analysed deductively focusing on appropriateness, acceptability and fidelity of the intervention. RESULTS: The intervention was considered appropriate for the patient group and the general practice setting. The providers acknowledged PST as a valuable tool for managing psychological issues in general practice, and the patients perceived PST as an effective and tangible treatment. Since practice nurses' schedules were generally better suited for longer consultations, they were often the preferred intervention providers. The intervention was largely delivered as intended. However, the GPs generally expected patients to prefer a more directive approach, which sometimes challenged their role as facilitator and guide. CONCLUSION: The Healthy Mind intervention was found to be feasible, and the results support proceeding to a full-scale evaluation trial.

Patients with type 2 diabetes and/or ischaemic heart disease often experience poor mental well-being, revealing a shortage of general practice-based interventions targeting this issue.This study evaluates the feasibility of a problem-solving therapy intervention in general practice for patients with poor mental health and type 2 diabetes and/or chronic ischemic heart disease.Both patients and healthcare providers regarded problem-solving therapy as an acceptable intervention for managing psychological issues in general practice.Healthcare providers preferred practice nurses as the providers of problem-solving therapy since their schedules were often more suitable for longer consultations.In problem-solving therapy, the provider is expected to take a facilitating and guiding role, but GPs sometimes struggled remaining in this role due to a preconceived anticipation that patients expected them to take a more directive approach.

Acquisition, application, and distribution of health literacy from culturally sensitive type 2 diabetes education among Arabic-Speaking migrants in Denmark: A longitudinal qualitative analysis.

BACKGROUND: Effective self-management of type 2 diabetes requires adequate health literacy (HL) and a supportive network. Diabetes self-management education and support programmes play a crucial role in improving these factors. However, limited research exists on how such programmes can support health literacy among migrants and facilitate the dissemination of knowledge within their social networks. AIM: This study aimed to investigate the perspectives of Arabic-speaking informants with a migrant background in relation to how their type 2 diabetes-related health literacy was acquired, applied and distributed within social networks through participation in a culturally sensitive diabetes self-management education and support (DSMES) programme. METHODS: Semi-structured interviews were conducted with 12 informants during the programme and three to 7 months later, from September 2019 to May 2020. Abductive analysis was applied using HL and distributed health literacy (DHL) theory as frameworks. RESULTS: The analysis generated three themes: (1) sources of health information and the development of health literacy; (2) changes towards active self-management; and (3) distributed health literacy. Prior to programme participation, informants faced challenges in navigating conflicting information from family, friends and social media. After participating in the programme, they reported improvements in HL, particularly in knowledge acquisition. Many became more actively engaged in decision-making and exhibited improved health behaviours, such as dietary choices. Nonetheless, some informants continued to struggle with choosing appropriate prevention and treatment strategies. Notably, certain informants acted as HL mediators, sharing their newly acquired knowledge within their social networks in Denmark and abroad. CONCLUSION: Culturally sensitive diabetes self-management education programmes have the potential to enhance HL among migrants, leading to the distribution of relevant diabetes knowledge within their social networks. Future studies should explore how members of migrants' social networks perceive their supportive role in type 2 diabetes management. Programmes can benefit from emphasising critical HL and exploring how participant-informants effectively communicate diabetes-related knowledge within their networks to address misinformation and conflicting information.

The Brief Health Literacy Scale for Adults: Adaptation and Validation of the Health Literacy for School-Aged Children Questionnaire.

The Health Literacy for School-Aged Children (HLSAC) is a brief, generic instrument measuring health literacy among school-aged children. Given its brevity and broad conceptualization of health literacy, the HLSAC is a potentially valuable measuring instrument among adults as well. This validation study aimed to adapt the HLSAC questionnaire to an adult population through assessment of content validity and subsequently determine the structural validity of the adapted instrument, the Brief Health Literacy scale for Adults (B-HLA). The content validity of the HLSAC was assessed through interviews with respondents and experts, and the structural validity of the adapted instrument (B-HLA) was evaluated using Rasch analysis. The content validity assessment (n = 25) gave rise to adjustments in the wording of five items. The B-HLA demonstrated an overall misfit to the Rasch model (n = 290). Items 6 and 8 had the poorest individual fits. We found no signs of local dependency or differential item functioning concerning sex, age, education, and native language. The B-HLA demonstrated unidimensionality and ability to discriminate across health literacy levels (PSI = 0.80). Discarding items 6 or 8 resulted in an overall model fit and individual fit of all items. In conclusion, the B-HLA appears to be a valid and reliable instrument for assessing health literacy among adults.

Health literacy among fathers and fathers-to-be: a multi-country, cross-sectional survey.

During pregnancy and early fatherhood, men are at higher risk of poor health, exacerbated by low engagement by healthcare services. Yet the transition to fatherhood presents an opportunity for men to improve their health and health behaviours. Health literacy refers to individuals' competence in accessing and applying health information. Poor health literacy is associated with poor health and low help-seeking. The aim of this study was to identify health literacy strengths, needs and profiles among fathers. Men who were expecting a baby ('antenatal') or had become fathers in the past 18 months ('postnatal') were recruited through an international, online paid survey platform. The survey included the nine-scale Health Literacy Questionnaire (HLQ). Of 889 survey respondents (n = 416, 46.5% antenatal; n = 473, 53.5% postnatal), 274 (31.0%) were residing in the USA and 239 (27.0%) in the UK. Relatively higher scores were reported for HLQ scales relating to having sufficient information and finding and understanding this information, as well as social support for health. Relatively lower scores were obtained for scales relating to actively managing one's own health and navigating the health care system. Three scale scores were significantly lower among nulliparous than multiparous men. Seven health literacy profiles were identified. In conclusion, while fathers have some health literacy strengths, they also experience some barriers, particularly first-time fathers. Awareness of diverse health literacy profiles among fathers may assist in developing strategies to strengthen health services' capacity to meet fathers' needs and reduce risks to their health at this critical juncture in families' lives.

Health promotion intervention among women with recent gestational diabetes mellitus: penetration, participation, and baseline findings from the Face-it randomized controlled trial.

INTRODUCTION: Face-it is a randomized controlled trial for women with recent gestational diabetes mellitus (GDM) and their families designed to evaluate the effect of a health promotion intervention on type 2 diabetes mellitus (T2DM) risk and quality of life. This study examined (1) the penetration and participation rates for the Face-it trial, (2) the characteristics of the participating women and the potential differences in characteristics according to partner participation status, and (3) representativity of the women at baseline. RESEARCH DESIGN AND METHODS: We identified women with GDM during pregnancy and invited them and their partners to a baseline examination 10-14 weeks after delivery. Representativity was assessed by comparing the baseline participants with non-participating women, the general population of women with GDM delivering in Denmark, and populations from other intervention trials. RESULTS: The penetration rate was 38.0% (867/2279) and the participation rate was 32.9% (285/867). The 285 women who attended baseline had a mean age of 32.7 (±4.8) years and body mass index (BMI) of 28.1 (±5.4) kg/m2, and 69.8% had a partner who participated. The women participating with a partner were more often primiparous, born in Denmark (82.8% vs 68.2%), were younger, and more often had a BMI ≤24.9 kg/m2 (35.7% vs 21.2%) compared with women without a partner. Compared with the general population of women with GDM in Denmark, these women broadly had similar degree of heterogeneity, but had higher rates of primiparity and singleton deliveries, and lower rates of preterm delivery and prepregnancy obesity. CONCLUSIONS: The penetration and participation rates were acceptable. We found a high rate of partner participation. Overall, women participating with a partner were comparable with those participating without a partner. Participating women were broadly similar to the general national GDM population, however with prepregnancy obesity, multiparity, preterm delivery, and multiple pregnancy being less represented. TRIAL REGISTRATION NUMBER: NCT03997773.

Motivation for Behavior Change among Women with Recent Gestational Diabetes and Their Partners-A Qualitative Investigation among Participants in the Face-It Intervention.

Promoting diet and physical activity is important for women with recent gestational diabetes mellitus (GDM) and their partners to reduce the risk of future type 2 diabetes (T2D). The study aimed to understand how motivation for changing diet and physical activity behaviors among women with recent GDM and their partners was experienced after participation in the Danish Face-it intervention. Fourteen couples' interviews were conducted. Data analysis followed a reflexive thematic analysis. Guided by self-determination theory and interdependence theory, we identified four themes affecting couples' motivation for health behavior change: (1) The need to feel understood after delivery; (2) adjusting health expectations; (3) individual and mutual preferences for health behaviors; and (4) the health threat of future T2D as a cue to action. We found that couples in general perceived the Face-it intervention as useful and motivating. Using couple interviews increased our understanding of how the women and partners influenced each other's perspectives after a GDM-affected pregnancy and thus how targeting couples as opposed to women alone may motivate health behavior change.

A Complex mHealth Coaching Intervention to Prevent Overweight, Obesity, and Diabetes in High-Risk Women in Antenatal Care: Protocol for a Hybrid Type 2 Effectiveness-Implementation Study.

BACKGROUND: Women with overweight and obesity are at higher risk of developing complications in pregnancy such as gestational diabetes and longer-term chronic conditions. Research concerning health behavior change interventions during pregnancy and postpartum shows promising effects, but implementation into routine services is sparsely investigated. Most interventions focus on the antenatal or postpartum life stages, failing to meet the needs of women. IMPACT DIABETES Bump2Baby is a multicenter project across 4 high-income countries developed to test the implementation of an antenatal and postpartum evidence-based mobile health (mHealth) coaching intervention called Bump2Baby and Me (B2B&Me) designed to sit alongside usual care in the perinatal period. OBJECTIVE: We aim to explore the feasibility and implementation of the B2B&Me intervention and investigate the effectiveness of this intervention in women at risk of gestational diabetes. METHODS: IMPACT DIABETES Bump2Baby is a hybrid type 2 effectiveness-implementation study, which integrates an evidence-based mHealth coaching app that includes personalized health behavior change coaching provided by health care professionals alongside antenatal care from the first antenatal visit to 12 months postpartum. The mHealth app offers the possibility of synchronous calls, asynchronous contact (including coach-participant text and video messaging exchanges tailored to the participant's needs), and ongoing access to an extensive library of bespoke intervention materials. Participants will interact asynchronously with their health coach throughout the intervention via the app. This randomized controlled trial across 4 clinical sites within Ireland, the United Kingdom, Spain, and Australia will recruit 800 women in early pregnancy to evaluate the effectiveness on postpartum weight. The Exploration, Preparation, Implementation, and Sustainment implementation framework is the theoretical underpinning of the study. The implementation evaluation will be assessed at the individual, hospital staff, and broader community levels using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources for the RE-AIM evaluation will include app and platform analytics, screening and training records, participant medical records, key informant interviews, participant and partner exit interviews, cost data, study questionnaires, staff surveys, and blood sample analyses. RESULTS: The study was approved and registered with the Australian New Zealand Clinical Trials Registry on November 19, 2020. Recruitment commenced on February 9, 2021, and data collection is ongoing. Publication of the results is expected in 2024. CONCLUSIONS: This is the first hybrid effectiveness-implementation study of an 18-month mHealth coaching intervention in at-risk women that we are aware of. As research aims to move toward real-world implementable solutions, it is critical that hybrid studies are conducted. The data from this large multicenter study will be useful in planning the potential implementation and scale-up of evidence-based perinatal health behavior change interventions. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620001240932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380020&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51431.

Mental well-being and patient activation during the first eight months of the COVID-19 pandemic in Denmark - a cohort study among 710 Danish adults with chronic conditions.

BACKGROUND: COVID-19 has highlighted the importance of patient activation in managing chronic conditions and promoting resilience during times of crisis. Patient activation refers to an individual's knowledge, skills, and confidence in managing their own health and healthcare. Previous research has shown that people with higher levels of patient activation are better prepared to navigate the challenges of chronic illness and are more likely to engage in healthy behaviors. However, the impact of patient activation on COVID-19-related concerns and mental well-being among people with chronic conditions during the pandemic remains unclear. This study aims to investigate the possible role of patient activation in shaping COVID-19-related concerns and to describe changes in mental well-being among Danish adults with one or more chronic conditions during the early months of the pandemic. METHODS: Danish adults with chronic conditions (e.g. diabetes, coronary heart disease, obstructive pulmonary lung disease, cancer) who had participated in a municipal health education program prior to the COVID-19 outbreak were asked to participate in this prospective questionnaire study in May 2020 and November 2020. Sociodemographic (sex, age, living status, educational attainment, employment status) and disease-related information (diagnosis, one or more chronic conditions) along with the Patient Activation Measure were collected before the outbreak and were obtained from a clinical database used for monitoring and evaluation of municipal health education programs. In contrast, the two questionnaires collected six months apart consisted of single items related to concerns about COVID-19 and the WHO-5 well-being index. RESULTS: A total of 710 people with chronic conditions (mean age 60.9 years; 55.8% female) participated at both time points. In bivariate analyses, patient activation was associated with COVID-19-related concern and well-being. At follow-up, participants experienced a significant decrease in well-being. The decrease was associated with poorer well-being measured six months earlier, a greater perception that it had become more challenging to take care of one's health due to the pandemic, and finally, feeling lonely. The association between patient activation and well-being ceased to be significant in the multivariate regression model. CONCLUSIONS: A considerable proportion of people with chronic conditions participating in this study have been mentally burdened during COVID-19. Although lower levels of patient activation were associated with greater COVID-19-related concerns, it did not have a significant impact on mental well-being over time.

Body Mass Index Trajectories in Children Exposed to Gestational Diabetes in Utero: A Nationwide Register-based Study.

CONTEXT: Children exposed to gestational diabetes mellitus (GDM) in utero are at high risk of developing overweight and obesity, but their postnatal growth trajectories and risk profiles remain unclear. OBJECTIVE: We aimed to identify distinct body mass index (BMI) trajectories from birth to 10 years of age in children exposed to GDM and to explore their associations with infant and maternal characteristics. METHODS: This nationwide cohort study linked data from Danish registries on 15 509 children exposed to GDM in utero, born in Denmark from January 2008 to October 2019. We applied latent class trajectory modeling to identify distinct BMI trajectories. Associations of BMI trajectories with infant and maternal characteristics were analyzed using multiple linear regression. RESULTS: We identified 3 distinct BMI trajectories characterized by a "normal" (60%), a "late accelerating" (28%) and an "early accelerating" (12%) BMI trajectory, the 2 latter at risk of overweight and obesity, respectively, at age 10 years, relative to World Health Organization child growth standards. Children in the "late accelerating" BMI trajectory were more often born large for gestational age (P < .001). More children in the "early accelerating" BMI trajectory were boys, born small for gestational age, and had mothers with a higher pre-pregnancy BMI compared to the other groups (P < .001). CONCLUSION: Children exposed to GDM in utero differ widely in their BMI trajectory. The detection of risk profiles based on early BMI growth and infant and maternal characteristics provides an opportunity for future targeted care and prevention.

Acceptability and adoption of the Face-it health promotion intervention targeting women with prior gestational diabetes and their partners: A qualitative study of the perspectives of healthcare professionals.

AIM: In this study, we investigated healthcare professionals' (HCPs) experiences with delivering home visits and digital coaching in the Face-it health promotion intervention targeting women with recent GDM and their families. Understanding the acceptability and adoption of a health promotion intervention can provide insights into intervention fidelity and future scalability. METHODS: In total, 13 HCPs were interviewed. Data were analysed thematically through an abductive approach using Sekhon et al.'s theoretical framework of acceptability and Greenhalgh et al.'s framework for non-adoption, abandonment, scale-up, spread, and sustainability. RESULTS: Acceptability and adoption of the intervention among HCPs were influenced by (1) skills and technology, (2) values, and (3) organisation. The intervention was experienced as acceptable to HCPs because the dialogue tool, visualising different topics, used in the home visits and digital coaching through the LIVA app were flexible and enabled them to address psychosocial health and personalise goal setting in families. However, delivering asynchronous and non-verbal communication was experienced as straining HCPs' relationship with families, which misaligned with HCPs' values. Establishing a non-judgemental environment was needed to increase intervention acceptability among HCPs towards addressing type 2 diabetes risk after GDM. Increased collaboration between HCPs may have aligned advice and support to families and could have benefitted delivery. CONCLUSIONS: When delivering health promotion to women with prior GDM, flexible intervention components that support psychosocial- and mental health topics may increase acceptability and adoption of the intervention among HCPs. HCPs' skills, values, and organisational factors should be considered prior and during implementation.

Participatory System Dynamics Approach Targeting Childhood Health in a Small Danish Community (Children's Cooperation Denmark): Protocol for a Feasibility Study Design.

BACKGROUND: Improving childhood health is complex due to the multifactorial nature and interaction of determinants. Complex problems call for complex intervention thinking, and simple one-size-fits-all solutions do not work to improve childhood health. Early awareness is important, as behavior in childhood often is manifested across adolescence and into adulthood. To facilitate shared understanding of the complex structures and relationships that determine children's health behavior, participatory system approaches in, for example, local communities have shown promising potential. However, such approaches are not used systematically within public health in Denmark, and before being rolled out, they should be tested for their feasibility within this context. OBJECTIVE: This paper describes the study design for Children's Cooperation Denmark (Child-COOP) feasibility study that is aiming to examine the feasibility and acceptability of the participatory system approach and the study procedures for a future scale-up controlled trial. METHODS: The feasibility study is designed as a process evaluation of the intervention with the use of both qualitative and quantitative methods. A local childhood health profile will provide data for childhood health issues, for example, daily physical activity behavior, sleep patterns, anthropometry, mental health, screen use, parental support, and leisure-time activities. Data at system level are collected to assess development in the community, for example, readiness to change, analysis of social networks with stakeholders, rippled effects mapping, and changes in system map. The setting is a small rural town in Denmark, Havndal, with children as the primary target group. Group model building, a participatory system dynamics method, will be used to engage the community, create consensus on the drivers of childhood health, identify local opportunities, and develop context-specific actions. RESULTS: The Child-COOP feasibility study will test the participatory system dynamics approach for intervention and evaluation design and survey objective measures of childhood health behavior and well-being among the ~100 children (6-13 years) attending the local primary school. Community-level data will also be collected. We will assess the contextual factors, implementation of interventions, and mechanisms of impact as part of a process evaluation. Data will be collected at baseline, at 2 years, and 4 years of follow-up. Ethical approval for this study was sought and granted from the Danish Scientific Ethical Committee (1-10-72-283-21). CONCLUSIONS: s: The potential of this participatory system dynamics approach includes opportunities for community engagement and local capacity building to improve children's health and health behavior, and this feasibility study holds the potential to prepare an upscaling of the intervention for effectiveness testing. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43949.

Does health literacy predict cardiometabolic marker trajectories among people with diabetes? A longitudinal mixed-effect analysis.

AIMS: To assess trajectories in cardiometabolic markers among people with type 1 and type 2 diabetes with varying health literacy levels. METHODS: Survey data assessing self-reported health literacy among 1401 people with type 1 diabetes and 910 people with type 2 diabetes were linked to prospective clinical data. Mixed effects modelling was used to identify the impact of three health literacy domains on trajectories of systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), and glycated hemoglobin (HbA1c). RESULTS: High health literacy scores in some domains were associated with attenuated HbA1c trajectories, while associations with LDL-C and SBP were weak or absent, particularly among participants with type 2 diabetes. The domain "Ability to Actively Manage Health" had the strongest association with HbA1c (P < 0.001). Exponential changes over time were not observed. Differences in the estimated progression of cardiometabolic markers by health literacy levels did not reach statistical significance. CONCLUSION: Low health literacy was associated with suboptimal glycaemic levels in type 1 and type 2 diabetes. There was inconclusive evidence of associations between health literacy, BP, and LDL-C. Development in cardiometabolic markers did not indicate faster diabetes progression among people with low health literacy.

Tackling physical inactivity in Scandinavia: a narrative review of reviews supplemented by expert interviews.

Aims: This study aims to identify physical inactivity-related challenges and motives, based on reviews and supplemented by expert interviews with Danish national experts on physical inactivity, providing a general discussion of the subject ultimately generating knowledge useable in a Scandinavian context. Methods: This study is framed as a narrative review of scientific review literature on physical inactivity, limited to the general population. The review is supplemented by expert interviews with Danish national experts on physical inactivity. We used thematic coding of the included reviews, while using hermeneutic interpretation analysis for the expert interviews. Results: Based on 11 included reviews, we highlighted four themes based on our analysis of reviews: (a) socioeconomic determinants of physical activity; (b) life-course perspective; (c) physical inactivity and older adults aged 60+ years; and (d) intervention recommendations. The supplementary expert interviews revealed three additional themes: (a) the individual history with physical activity; (b) sporting organisation importance; and (c) society responsibility for physical inactivity. Conclusions: Collectively this study concludes, based on review and expert interviews, that a number of determinants and correlations for physical inactivity affect the individual from various socioecological levels. Based on this review, we suggest moving beyond the 'upstream' public health approach of randomised controlled trials and consider complex interventions targeting physical inactivity from several levels. Physical inactivity should be acknowledged as a 'wicked problem' that requires a systems-based approach instead of a single quick fix. Future work with physical inactivity would profit from focus on the life-course perspective, sporting clubs' responsiveness and physical literacy.

Multimorbidity and health literacy: A population-based survey among 28,627 Danish adults.

AIM: Individuals with multimorbidity often have complex healthcare needs challenging their health literacy skills. This study aimed to investigate the association between the number of physical conditions and health literacy and to examine the difference in health literacy levels between individuals with multimorbidity based on physical conditions and individuals with additional mental disorders. METHODS: Respondents aged 25 years or older from a Danish population-based survey were included (N = 28,627). Multimorbidity was assessed based on 18 self-reported chronic conditions; health literacy was measured using two scales from the Health Literacy Questionnaire focusing on understanding health information and engaging with healthcare providers. Associations were examined using multiple logistic regression analysis. RESULTS: We found a positive association between number of physical conditions and the odds of having difficulties in understanding health information and engaging with healthcare providers. For example, the adjusted odds ratio (OR) of having difficulties in understanding health information was 1.45 (95% confidence interval (CI): 1.09-1.94) for individuals with two physical conditions compared with individuals without multimorbidity. The associations formed a positive exposure-response pattern. Furthermore, respondents with both mental and physical conditions had more than twice the odds of having health literacy difficulties compared to respondents with only physical conditions (adjusted OR 2.53 (95% CI 2.02-3.18) and 2.28 (95% CI 1.92-2.72) for the scales, respectively). CONCLUSIONS: Our results suggest that responding to patients' health literacy needs is crucial for individuals with multimorbidity - especially those with combined mental and physical conditions.

Physical activity in pregnancy: a mixed methods process evaluation of the FitMum randomised controlled trial interventions.

BACKGROUND: Physical activity (PA) at moderate intensity is recommended for healthy pregnant women. The three-arm FitMum randomised controlled trial showed that it was possible to increase PA level during pregnancy with structured supervised exercise training (EXE) compared to standard care. Motivational counselling on PA (MOT) did not increase PA. This process evaluation aims to understand the implementation and mechanisms of impact of EXE and MOT. METHODS: A mixed methods process evaluation was conducted using the UK Medical Research Council's process evaluation framework by assessing implementation (reach, fidelity, and dose) and mechanisms of impact of the two interventions provided to pregnant women in FitMum. Data was collected both quantitatively (n = 220) and qualitatively (n = 20). RESULTS: The FitMum trial reached educated pregnant women (80% having an educational level ≥ bachelor's degree) with high autonomy of everyday life. Most participants (58%) were recruited at their first-trimester ultrasonic scan. Reasons to participate were personal (91%) and altruistic (56%). The intervention dose was delivered as intended with high fidelity in the original physical intervention setup and in the altered online setup during the COVID-19 restrictions. A low dose received in EXE (1.3 [95% CI, 1.1; 1.5] sessions/week) was partly explained by the pre-scheduled EXE sessions favouring participants with a flexible everyday life and a supportive social network. Dose received in EXE increased during online intervention delivery. Participants in MOT received 5.2 [4.7; 5.7] of 7 sessions. Mechanisms of impact comprised a perception of intervention commitment among participants in EXE due to the scheduled EXE sessions, whereas participants in MOT considered themselves as PA self-determined. PA was considered as constrained activities in EXE and included in daily activities in MOT. CONCLUSION: The FitMum interventions was delivered with high fidelity. During COVID-19, the dose received in EXE increased compared to the previous physical setup. Mechanisms of impact as commitment, perception of empowerment and perception of PA as well as the paradox between prioritising PA and family and the need of a flexible everyday life need to be considered when offering pregnant women PA interventions. Future interventions should consider a combination of physical and online exercise training for pregnant women.

Identifying Health Literacy Responsiveness Improvement Ideas in Danish Health Centers: Initial Testing of the OS! Approach.

BACKGROUND: Health services hold a critical role in mitigating the effect of health literacy challenges. Several tools and approaches have been developed to support health organizations in responding to their target population's health literacy needs. One of these is the OS! approach, which is an adapted and less rigorous version of the Australian Organizational health literacy responsiveness tool (Org-HLR). In this study, we aimed to report on our initial testing of the OS! approach in two Danish health care settings. BRIEF DESCRIPTION: The OS! aim to prompt and support the development of local organizational health literacy improvement ideas. The process consists of three consecutive workshops focusing on reflection, self-evaluation, and prioritization. For each workshop tools are provided to support implementation. IMPLEMENTATION: The OS! approach was tested in two Danish municipal health centers (Tårnby Health Centre and Frederiksberg Health Centre), where both staff members and leaders took part in the processes (N = 62 and N = 84). In Tårnby, the process was closely facilitated by the research team, while local managers was in charge of the implementation in Frederiksberg. RESULTS: In both settings, the process succeeded in identifying a list of relevant prioritized action ideas aimed at improving local health literacy responsiveness. In both instances, leaders were able to integrate some of these ideas in action plans for the organizations nearby future. LESSONS LEARNED: We found the OS! approach effective in its aim to identify health literacy responsiveness improvement ideas and based on our experience also less arduous to implement than the Org-HLR. We also learned that good implementation of the OS! approach depends strongly on careful facilitation including thorough introduction of the concepts of health literacy, openness, and creativity in relation to local adaptions within the overall framework of the approach, and the consolidation of consistent leader support throughout the organization. [HLRP: Health Literacy Research and Practice. 2022;6(3):e232-e238.] Plain Language Summary: This study describes the initial testing of the OS! APPROACH: The OS! approach is based on the Australian methodology "Org-HLR" and use a participatory approach to prompt and support the identification of local health literacy responsiveness improvement ideas in health care organizations. The article provides valuable experiences regarding local development of organizational health literacy in practice.

Self-reported measurements of physical literacy in adults: a scoping review.

Physical literacy (PL) is a comprehensive concept covering motivation, confidence, physical competence, knowledge and understanding of individuals' physical activity throughout life. PL has three overlapping domains, such as: an affective, a physical and a cognitive domain. So far, PL has not been measured in the adults and no complete measurement has been developed to date. OBJECTIVES: The aim of this scoping review was to review existing self-reported instruments measuring different elements of domains of PL. METHOD: We reviewed Education Research Complete, Cochrane, Medline, ScienceDirect, Scopus and SPORTDiscus. The reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Studies were coded using a thematic framework, which was based on the three domains of PL. The eligibility criteria were as follows: (1) age groups between 18 and 60 years; (2) meta-analyses, reviews or quantitative studies focusing on the measurement of at least one of the three domains of PL and (3) instrument that was self-reported. We finalised search on 1 August 2021 RESULTS: In total, 67 articles were identified as studies describing instruments reflecting the three domains of PL. Following full-text reading, 21 articles that met our inclusion criteria were included. Several instruments of relevance to PL are available for assessing motivation, confidence and the physical domain. However, few instruments exist that measure elements of the cognitive domain. CONCLUSION: This review showed that a range of existing and validated instruments exists, covering two out of the three domains of PL, namely affective and physical domains. However, for the knowledge domain no valid measurement tools could be found. This scoping review has identified gaps in the research (namely the cognitive domain) and also a gap in the research as no measures that consider the inter-relatedness of the three domains (holistic nature of the concept).