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3.1. Baseline characteristics | As depicted in | PMC10745664 | ||
3.2. 24 h Ambulatory Blood Pressure Monitoring | Results were obtained before and after each intervention period. We analysed 24 h measurements, however, no intra- or inter group differences were found ( | PMC10745664 | ||
3.3. Blood Analyses | Overall, we observed no effects on hs-CRP or adiponectin. However, there was a trend towards improvements upon supplementation with AE, with a 17% decrease in hs-CRP and −0.59 ± 0.26 mg/L decrease in adiponectin. Regarding lipids, the intra-group analysis revealed several increases distributed across all groups after s... | PMC10745664 | ||
4. Discussion | T2D | CVD, LIPIDAEMIA | In this study, we investigated the effects on cardiovascular risk factors of an eight-week supplementation with aronia extract, fermented aronia extract, and placebo, respectively, in subjects with T2D. After an 8-week supplementation with aronia, we did not observe any significant differences in blood pressure, adipon... | PMC10745664 |
5. Conclusions | cardiometabolic diseases, T2D | In conclusion, aronia extracts, both fermented and non-fermented, could contribute to improvements in lipid profiles in subjects with T2D, but more high-quality studies are needed to confirm our findings. Preferably, these studies should be performed using aronia in its pure form to avoid the possible interference of r... | PMC10745664 | |
Author Contributions | Conceptualization, C.B.C., P.B.J., K.H. and S.G.; validation, C.B.C., P.B.J., K.H. and S.G.; formal analysis, C.B.C.; investigation, C.B.C.; data curation, C.B.C.; writing—original draft preparation, C.B.C.; writing—review and editing, P.B.J., K.H. and S.G.; supervision, P.B.J., K.H. and S.G.; project administration, C... | PMC10745664 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board (or Ethics Committee) of The Central Denmark Region Committees on Health Research Ethics (Journal no. 1-10-72-102-19, 12 August 2019). | PMC10745664 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10745664 | ||
Data Availability Statement | Data supporting reported results can be obtained by contacting the corresponding author. | PMC10745664 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10745664 | ||
References | Study design. (CONSORT diagram with overview of enrolment and discontinuation. Reprinted with permission from [Mean pre and post values for fasting levels of LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglycerides. Data are presented as mean ± standard error. * indicates a significant difference between ... | PMC10745664 | ||
Abstract | PMC10128158 | |||
Background | Communal exercise interventions may help prevent falls and injuries. However, pragmatic trials demonstrating the effectiveness of such strategies are sparse. | PMC10128158 | ||
Methods | We determined whether a cost-free 12-month admission to the city’s recreational sports facilities including initial 6 months of supervised weekly gym and Tai Chi sessions decreases the number of falls and related injuries. The mean (SD) follow-up time was 22·6 (4.8) months in 2016–19. A total of 914 women from a popula... | PMC10128158 | ||
Results | A 14.3% fall rate reduction was detected in the exercise group (Incidence rate ratio (IRR) = 0.86; CI 95% 0.77–0.95) compared with the control group. Approximately half of the falls caused moderate ( | PMC10128158 | ||
Conclusions | fractures | A community-based approach for a 6-month exercise period combined with a 12-month free use of sports premises can reduce falls, fractures and other fall-related injuries in aging women. | PMC10128158 | |
Key Points | injuries, pain | A two-year randomized controlled fall prevention study on community-dwelling older women.The greatest reduction was observed in falls with severe injury and pain.Community-driven fall prevention with light- or moderate-intensity exercise group programmes can reduce falls and fall injuries on a municipal scale. | PMC10128158 | |
Introduction | fractures | SECONDARY | The global proportion of people over 60 years is expected to double between 2000 and 2050 [Community-wide effects of fall prevention in the aging population warrant large-scale studies. Thus, pragmatic randomized controlled trial (RCT) studies with societal fall prevention strategies showing real-world effectiveness sh... | PMC10128158 |
Methods | PMC10128158 | |||
Study design | Kuopio Fall Prevention Study (KFPS) is a randomized controlled study conducted in cooperation with the municipality of Kuopio, with a population of ~120,000 inhabitants in eastern Finland. All the participants living in Kuopio urban area, born between 1932 and 1945, were invited through mass mailings using their home a... | PMC10128158 | ||
Participants, randomization and masking | dementia | PULMONARY DISEASE, UNSTABLE ANGINA PECTORIS | Between 1 January 2016 and 31 March 2016, an information letter was sent to 4,262 home dwelling women living within a 10-km radius of the city centre, asking their willingness to participate in the 2-year randomized exercise trial, resulting in 1,600 responses. The exclusion criteria were self-reported unstable angina ... | PMC10128158 |
Primary and secondary outcomes | Fracture, fractures, syncope, pain | SECONDARY, EVENT | We studied the effect of an exercise intervention on the primary outcome, i.e. falls. In addition, falling mechanisms, injurious falls and fractures were analysed as the secondary outcome. All outcomes shared the same inclusion criteria (of tripping, slipping, syncope or similar event from less than 1-m height). The me... | PMC10128158 |
Clinical measurements | RECRUITMENT | Clinical measurements were accomplished in Kuopio Musculoskeletal Research Unit at baseline for 914 (100%), and at 12- and 24-month follow-ups for 850 (93.0%) and 838 (91.7%) women, respectively (The study recruitment, screening and participation. | PMC10128158 | |
Exercise intervention and use of city premises | The women randomized to exercise intervention were allocated to 27 groups, each including 15–18 attendees. Same groups were maintained in both Tai Chi (‘Taiji’) and gym sessions. No additional support (such as motivational reminders, etc.) was given to women during the trial. The control group received education on fal... | PMC10128158 | ||
Gym | All gym sessions were supervised by two physiotherapists for the initial 6 months. The aim of the first four visits (weeks) to the gym was to familiarize study subjects with the safe and appropriate use of the weight training equipment. No free weights were used. The training prioritized postural muscle groups of legs ... | PMC10128158 | ||
Tai chi | The Tai Chi course—designed and executed in cooperation with a professional Tai Chi instructor—aimed to reduce falls by improving balance, posture and active range of motion through the variations of classic Tai Chi exercises. The protocol progressed from simple postural control, body weight shifting and static balance... | PMC10128158 | ||
Sample size and statistical analysis | fall injury, Fracture | REGRESSION | Previous meta-analyses and RCTs reported heterogeneous dropout rates depending on factors such as geographic location, sociodemographic status, and duration and intensity of the protocol [The Fall risk analyses were conducted according to the intention-to-treat by including all women up to their last confirmed fall inf... | PMC10128158 |
Results | PMC10128158 | |||
Participants and adherence | deaths | The mean age of the women at baseline was 76.5 (3.3). The total number of dropouts was 76 (8.3%) including deaths (Baseline characteristics of the study population with the follow-up change of bone densitometry and functional tests
| PMC10128158 | |
Falls and injuries | fracture, fractures | A total of 1,380 falls were registered during the 24 months. Of these, 1,281 (92.8%) were reported through SMS, the rest being recorded from study diaries. The mean follow-up (SD) for the falls was 23.8 months. In total, 15 women did not respond to any fall inquiry and were excluded from the primary analyses. The propo... | PMC10128158 | |
Clinical measurements | A complete 24-month follow-up data were available for 831 (90.9%) women. BMD or body composition results did not change during the follow-up. However, in functional tests, the leg extension strength decreased slightly less (−1.7 versus −3.8%, | PMC10128158 | ||
Discussion | fall injuries, fall injury, fractures, fall reduction, KFPS, injury and pain | EVENTS, EVENT | The KFPS is a large population-based fall prevention RCT targeted at older community-dwelling women with minimal exclusion criteria. Weekly Tai Chi and gym exercises were combined with free access to recreational facilities, aiming to reduce the number of falls in a 24-months follow-up. The proportion of women who had ... | PMC10128158 |
Supplementary Material | Click here for additional data file. | PMC10128158 | ||
Acknowledgements | The authors appreciate the invaluable help of Tarmo Hakkarainen in the design and implementation of the Taiji protocol. We also thank the physiotherapists Sirpa Mattsson-Taskinen and Marjatta Mäkinen for their professional management of the gym exercise protocol, research nurses Pirkko Kanerva and Saara Lappalainen for... | PMC10128158 | ||
Declaration of Conflicts of Interest | None. | PMC10128158 | ||
Data Availability Statement | The data underlying this article will be shared on reasonable request to the corresponding author. | PMC10128158 | ||
Declaration of Sources of Funding | The work was supported by the Juho Vainio Foundation, the Ministry of Education and Culture, the Academy of Finland (Grant No. 310831/2017) and the KUH Research Fund (to V.T.R.). | PMC10128158 | ||
Ethics Approval | The OSTPRE and KFPS studies have been reviewed and approved by the Ethics Committee of the Hospital District of North Savo and Kuopio University Hospital on 31 January 2014, 29 April 2016 and 16 December 2016. All regulations and measures of confidentiality were handled in accordance with the Declaration of Helsinki. | PMC10128158 | ||
References | PMC10128158 | |||
Background | Germ Defence ( | PMC10694966 | ||
Methods | With NHS England approval, we conducted an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via general practitioner (GP) practices across England, UK, compared with usual care to disseminate Germ Defence to patients. GP p... | PMC10694966 | ||
Results | Germ Defence was used 310,731 times. The average website satisfaction score was 7.52 (0–10 not at all to very satisfied, | PMC10694966 | ||
Conclusions | While the RCT did not demonstrate a difference in health outcomes, we demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible and can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research... | PMC10694966 | ||
Trial registration | This trial was registered in the ISRCTN registry (14602359) on 12 August 2020. | PMC10694966 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13012-023-01321-z. | PMC10694966 | ||
Keywords | RECRUITMENT |
Due to the need to rapidly implement the Germ Defence intervention during the COVID-19 pandemic, a novel efficient trial design was adopted, evaluating an active intervention across all GP practices in England.The paper outlines the efficient trial design, where no GP practice or patient recruitment was required, and ... | PMC10694966 | |
Introduction | respiratory tract infection, infection, infections | RESPIRATORY TRACT INFECTIONS, RECRUITMENT, INFECTIONS, INFECTION, RESPIRATORY TRACT INFECTION | The COVID-19 pandemic has highlighted the importance of behavioural strategies for controlling infection transmission. Effective implementation of good hygiene practices as public health measures (including social distancing, self-isolation, handwashing, mask wearing and ventilation) was vital to control the spread unt... | PMC10694966 |
Method | PMC10694966 | |||
Design | As detailed in our protocol [ | PMC10694966 | ||
Setting and participants | All GP practices in England registered with NHS Digital ( | PMC10694966 | ||
Sample size considerations | To detect a relative risk reduction of 0.14 with 90% power (alpha 0.05), based on the previous Germ Defence implementation, PRIMIT trial [ | PMC10694966 | ||
Intervention | infection | INFECTION | Germ Defence content was rapidly adapted throughout the pandemic using state-of-the-art evidence, theory and the person-based approach [The original Germ Defence intervention drew on the theory of planned behaviour [The single-session intervention sought to improve users’ awareness of risks of infection and transmissio... | PMC10694966 |
Intervention implementation | An initial email to practices was drafted by the research team that contained a unique weblink to the Germ Defence website and asked practices to disseminate this to all their adult patients (aged 16 +) via mobile phone text, email or social media. This email was iteratively optimised in pilot interviews with nurses, G... | PMC10694966 | ||
Measures and outcomes | RESPIRATORY TRACT INFECTIONS, GASTROINTESTINAL INFECTION, SECONDARY, RTI | The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per registered patient. Secondary outcomes comprised the rates of acute RTIs, COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic prescriptions and hospital admissions. COVID-19 symptoms were ... | PMC10694966 | |
Patient and public involvement | Patient and public involvement (PPI) feedback was a key part of the co-participatory approach of the development of Germ Defence, in which members of the public were invited to feed back about the website and study in order to optimise and update it. A public contributor (C. R.) was a coinvestigator on the study team a... | PMC10694966 | ||
Data analysis | PMC10694966 | |||
Summary of baseline data | infection | INFECTION | This cluster randomised controlled trial was analysed at the practice level. Randomisation was carried out at practice level, and we did not have direct feedback on whether practices distributed the Germ Defence information to all, some or potentially no patients, nor whether individual patients were offered the inform... | PMC10694966 |
Intention-to-treat analyses | REGRESSION | The primary analysis used a standard intention-to-treat approach. For each of the eight health outcomes, rates of consultations per registered patient were compared at practice level between intervention and control groups for the 17-week post-intervention period. This was done using negative binomial regression with t... | PMC10694966 | |
Controlled interrupted time-series analyses | REGRESSION | An additional analysis was performed for the same eight health outcomes using a controlled interrupted time-series (CITS) approach to understand temporal changes related to the intervention as distinct from the time-agnostic intention-to-treat approach. This was implemented within a generalised linear-mixed modelling f... | PMC10694966 | |
Process analysis | PMC10694966 | |||
Implementation process | Germ Defence website usage recorded from the unique identifying website links sent by each practice was used to examine whether intervention engagement (i.e. a practice effectively communicating link to patients) was predicted by practice characteristics (such as indices of deprivation, NHS Quality and Outcomes Framewo... | PMC10694966 | ||
Individual intervention usage | A range of additional behavioural mechanisms, overall patterns of practice and user engagement were described using website analytics. Analytics included number of users per practice, average time spent on the Germ Defence website and pages visited. | PMC10694966 | ||
Association with health outcomes | To understand the mechanisms of action in the intervention, we examined the association between the rate of website usage within a practice (number of users divided by number of registered patients) and the rate of each health outcome (consultations per registered patient). A negative binomial model was applied to prac... | PMC10694966 | ||
Information governance and ethical approval | WEST | NHS England is the data controller for OpenSAFELY-TPP, TPP is the data processor and all study authors using OpenSAFELY have the approval of NHS England. This implementation of OpenSAFELY is hosted within the TPP environment which is accredited to the ISO 27001 information security standard and is NHS IG (information g... | PMC10694966 | |
Results | The initial 10 November 2020 email to 3292 intervention arm practices from 133 CCGs reached 2679 GP practices. The subsequent reminder emails on 25 November and 10 December 2020 reached 2870 GP practices (Fig. Germ Defence trial CONSORT flow diagramData show that the Germ Defence website was viewed by patients from 16%... | PMC10694966 | ||
Controlled interrupted time series analysis | For all eight health outcomes analysed using CITS models, there was no clear evidence of intervention-related change (Table Controlled interrupted time-series estimates assessing intervention-related changesEstimates for changes in trend represent relative change in rate over the 17-week post-intervention period compar... | PMC10694966 | ||
Intervention implementation | Details of Germ Defence were emailed to 2870 intervention arm GP practices. The practice unique Germ Defence weblink was accessed by 1094 intervention arm practices (38.1%) at least once. Patient engagement within intervention arm practices ranged from no engagement (when no patient in a practice visited the Germ Defen... | PMC10694966 | ||
Individual intervention usage | infection | INFECTION | The trial intervention link was used 310,731 times, of which 163,991 ‘bounced’, i.e. did not engage beyond first the page. Access to the Germ Defence website using the generic (‘non-trial’) link also increased substantially during the trial period. This is likely due to trial users sharing the website (e.g. with their ... | PMC10694966 |
Practice-level usage and health outcomes | There was no clear evidence of an association between website usage rates and health outcomes either among all intervention practices or among those with a user rate greater than 1% (Table Process evaluation. Associations between website user rates and consultation rates for intervention practicesRate ratios indicate c... | PMC10694966 | ||
Efficient trial design and intervention implementation | CMO, Covid infection | The trial was endorsed by Chris Whitty, the then chief medical officer (CMO) for England, as a national priority project and adopted by the CRN as an urgent public health portfolio study. These endorsements facilitated the novel design by allowing access to email addresses of all GP practices via NHS Digital. However, ... | PMC10694966 | |
Discussion | respiratory tract infections, infection | RESPIRATORY TRACT INFECTIONS, VIRUS, INFECTION | We implemented a novel efficient trial design which was also the first RCT where follow-up was conducted entirely within a TRE. We did not find any consistent overall evidence that the intervention impacted rates of respiratory tract infections or other health outcomes. Similarly, we found no evidence that higher user ... | PMC10694966 |
Limitations | infection, word of mouth | INFECTION | This ‘low burden’ design comes with risks. Evaluating an accessible behavioural intervention that can be passed on via multiple communication pathways means we could not prevent people from using the intervention who were not from our randomised intervention group, nor could we control broad contextual factors that may... | PMC10694966 |
Conclusions | SECONDARY | In this study we used a novel, efficient prospective randomised controlled trial methodology to examine the rapid implementation and effectiveness of an active digital behavioural intervention across every GP practice in England. The RCT demonstrated that rapid large-scale implementation of a digital behavioural interv... | PMC10694966 | |
Authors’ contributions | RA, MM | LY, BA, JH, MC, JDD, JM, JS and PM contributed to the design of the trial. LY, BA, JH, MC, PM, JDD, FdV, ME, PC, RD, JM, JS, SM, BS, PL, SW, RA, NF, KM, CR, LT, MW and MM were members of the project team and contributed to trial conduct interpretation of the study findings. HJC, CB, AM, SB, BG and the OpenSAFELY Collab... | PMC10694966 | |
Funding | ARC | WEST, CORONAVIRUS | This research is funded by UKRI Coronavirus Rapid Response Call (CV220-009) and National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) West at University Hospitals Bristol and Weston NHS Foundation Trust and NIHR Health Protection Research Unit (HPRU) in Behavioural Science and Evaluation at... | PMC10694966 |
Availability of data and materials | All analyses involving health outcomes were conducted in the OpenSAFELY research platform, and data cannot be made available outside that platform other than approved aggregated study results. A GitHub repository containing all analysis scripts used in OpenSAFELY for this study can be found here: | PMC10694966 | ||
Declarations | PMC10694966 | |||
Ethics approval and consent to participate | WEST | Provisional ethics approval was originally obtained from the NHS Health Research Authority, Yorkshire & The Humber—Leeds West Research Ethics Committee (20/YH/0261) on 14 August 2020, followed by full approval on 2 September 2020. Practices which supported the study by promoting the Germ Defence website did in doing so... | PMC10694966 | |
Consent for publication | This research has been approved for publication by NHS England. | PMC10694966 | ||
Competing interests | A. | LUNG, ASTHMA | B. G., H. J. C., S. B. and A. M. have received research funding from the Laura and John Arnold Foundation, the NHS National Institute for Health Research (NIHR), the NIHR School of Primary Care Research, NHS England, the NIHR Oxford Biomedical Research Centre, the Mohn-Westlake Foundation, NIHR Applied Research Collabo... | PMC10694966 |
References | PMC10694966 | |||
Background | A barrier to achieving first trimester antenatal care (ANC) attendance in many countries has been the widespread cultural practice of not discussing pregnancies in the early stages. Motivations for concealing pregnancy bear further study, as the interventions necessary to encourage early ANC attendance may be more comp... | PMC10207755 | ||
Methods | GESTATIONAL DIABETES MELLITUS | Five focus groups with a total of 30 married, pregnant women were conducted to assess the feasibility of conducting a randomised controlled trial to evaluate the effectiveness of early initiation of physical activity and/or yoghurt consumption in reducing Gestational Diabetes Mellitus in pregnant women in The Gambia. F... | PMC10207755 | |
Results | ’ | MISCARRIAGE | Two reasons for the concealment of pregnancies in the first trimester or ahead of a pregnancy’s obvious visibility to others were given by focus group participants. These were ‘pregnancy outside of marriage’ and ‘evil spirits and miscarriage.’ Concealment on both grounds was motivated through specific worries and fears... | PMC10207755 |
Conclusion | Women’s lived experiences of evil spirits have been under-explored in qualitative health research as they relate specifically to women’s access to early antenatal care. Better understanding of how such sprits are experienced and why some women perceive themselves as vulnerable to related spiritual attacks may help heal... | PMC10207755 | ||
Keywords | PMC10207755 | |||
Background | COMPLICATIONS | Early antenatal care (ANC) attendance (within the first trimester) is associated with fewer complications during pregnancy and delivery, reduced maternal and infant mortality, and better life course outcomes for children [The Gambia is one nation in SSA which has made recent substantial progress in improving maternal a... | PMC10207755 | |
Methods | PMC10207755 | |||
Design | GDM | GDM, GESTATIONAL DIABETES MELLITUS | The data analysed in this study emerged from focus groups which were collected in support of a Randomised Control Trial (RCT) evaluating the effectiveness of early initiation of physical activity and/or yoghurt consumption in reducing Gestational Diabetes Mellitus (GDM) in pregnant women [Focus groups were chosen to ob... | PMC10207755 |
Study setting | The focus groups were conducted at the Kanifing General Hospital in The Gambia. Kanifing General Hospital is a tertiary referral facility, located in the urban Kanifing Municipality, the most densely populated settlement in The Gambia [ | PMC10207755 | ||
Participant sampling and recruitment | The FGDs were covered under the wider RCT’s feasibility study ethical clearance. All methods were performed in accordance with the Declaration of Helsinki’s guidelines. The study was approved by The Gambia Government/MRCG joint ethics committee (SCC 1620).We used convenience sampling to recruit participants for the foc... | PMC10207755 | ||
Study population | Five FGDs were conducted in February 2019 with 30 married pregnant women aged 16–37 years old who reported between one and six pregnancies (including their current pregnancy) (see Table Participant characteristics | PMC10207755 | ||
Data collection | A pre-written FGD guide was used to facilitate the discussions. The guide (Table Focus group discussion guideFGDs were facilitated by two Gambian researchers: an experienced female social scientist, who has successfully collected data on many similar studies with pregnant Gambian women, assisted by a male research clin... | PMC10207755 | ||
Patient and public involvement | Patients or the public were not involved in the design, conduct, or reporting plans of this research but the preliminary outcome of the findings were considered for the final draft of protocol of the RCT. A summary of the main trial results will be disseminated to the general public and study participants after the com... | PMC10207755 | ||
Data analysis | The analysis in this paper focuses specifically on women’s answers relating to FGD theme number one, ‘willingness to book for ANC in first trimester’, and the ways in which beliefs can be barriers to intervention and protocol adherence. Transcripts were uploaded into NVivo (v12) and, using Braun and Clarke’s thematic a... | PMC10207755 | ||
Results | ’ | MISCARRIAGE, EARLY PREGNANCY | Two reasons for the concealment of pregnancies in the first trimester or ahead of a pregnancy’s obvious visibility to others, were given by FGD participants. These were ‘pregnancy outside of marriage’ and ‘evil spirits and miscarriage’. Concealment on both grounds was motivated through specific worries and fears. In th... | PMC10207755 |
Pregnancy outside of marriage | FGD participants reported that women who found themselves pregnant outside of marriage were understood to be less likely to attend early ANC for fear of running into acquaintances at the clinic and the pregnancy being revealed. This theme was spoken about in generalised terms with no specific examples presented.Respond... | PMC10207755 | ||
Evil spirits and miscarriage | miscarriages, miscarriage | MISCARRIAGES, MISCARRIAGE | The more prevalent discourse related to the concealment of pregnancy was linked to local cultural beliefs around the causes of miscarriage. Many of the women interviewed held the view that making one’s pregnancy known to others at an early stage places one at greater risk of miscarriage as pregnancy makes one vulnerabl... | PMC10207755 |
Discussion | miscarriages, ’ | MISCARRIAGES, MISCARRIAGE | This qualitative analysis of FGD data considered the reasons for which women in urban Gambia might choose to conceal a pregnancy. It identified ‘pregnancy outside of marriage’ and ‘evil spirits and miscarriage’ as two distinct reasons a woman may wish to conceal a pregnancy, including from healthcare workers by not att... | PMC10207755 |
Limitations | The limitations of this analysis are chiefly related to the targeted questions of FGDs not being focussed on concealment and with this theme arising naturally. Notably absent in FGD participants’ reasons for concealing are prohibitions on postpartum sexual relations, which are well-documented in Gambia and SSA more bro... | PMC10207755 |
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