Purpose – Self-efficacy has often been found to play a significant role in healthy dietary behaviours. However, self-efficacy interventions most often consist of intensive interventions. The authors aim to provide more insight into the effect of brief self-efficacy interventions on healthy dietary behaviours. Design/methodology/approach – In the present article, two randomized controlled trials are described. In study 1, a brief self-efficacy intervention with multiple self-efficacy techniques integrated on a flyer is tested, and in study 2, an online brief self-efficacy intervention with a single self-efficacy technique is tested. Findings – The results show that a brief self-efficacy intervention can directly increase vegetable intake and indirectly improve compliance to a diet plan to eat healthier. Originality/value – These findings suggest that self-efficacy interventions do not always have to be intensive to change dietary behaviours and that brief self-efficacy interventions can also lead to more healthy dietary behaviours.
DOCUMENT
OBJECTIVES: Knee osteoarthritis (OA) is characterized by its heterogeneity, with large differences in clinical characteristics between patients. Therefore, a stratified approach to exercise therapy, whereby patients are allocated to homogeneous subgroups and receive a stratified, subgroup-specific intervention, can be expected to optimize current clinical effects. Recently, we developed and pilot tested a model of stratified exercise therapy based on clinically relevant subgroups of knee OA patients that we previously identified. Based on the promising results, it is timely to evaluate the (cost-)effectiveness of stratified exercise therapy compared with usual, "nonstratified" exercise therapy.METHODS: A pragmatic cluster randomized controlled trial including economic and process evaluation, comparing stratified exercise therapy with usual care by physical therapists (PTs) in primary care, in a total of 408 patients with clinically diagnosed knee OA. Eligible physical therapy practices are randomized in a 1:2 ratio to provide the experimental (in 204 patients) or control intervention (in 204 patients), respectively. The experimental intervention is a model of stratified exercise therapy consisting of (a) a stratification algorithm that allocates patients to a "high muscle strength subgroup," "low muscle strength subgroup," or "obesity subgroup" and (b) subgroup-specific, protocolized exercise therapy (with an additional dietary intervention from a dietician for the obesity subgroup only). The control intervention will be usual best practice by PTs (i.e., nonstratified exercise therapy). Our primary outcome measures are knee pain severity (Numeric Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score subscale daily living). Measurements will be performed at baseline, 3-month (primary endpoint), 6-month (questionnaires only), and 12-month follow-up, with an additional cost questionnaire at 9 months. Intention-to-treat, multilevel, regression analysis comparing stratified versus usual care will be performed.CONCLUSION: This study will demonstrate whether stratified care provided by primary care PTs is effective and cost-effective compared with usual best practice from PTs.
DOCUMENT
Background: To facilitate adherence to adaptive pain management behaviors after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behavior regulation strategies. Objective: The aims of this project are (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app users. Methods: We will perform a multicenter randomized controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment program until 12 months posttreatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses. Results: The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients. Conclusions: This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After 3 years of development and feasibility testing, this formal evaluation will help determine to what extent the app will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice.
LINK
Background: Early childhood caries is considered one of the most prevalent diseases in childhood, affecting almost half of preschool-age children globally. In the Netherlands, approximately one-third of children aged 5 years already have dental caries, and dental care providers experience problems reaching out to these children. Objective: Within the proposed trial, we aim to test the hypothesis that, compared to children who receive usual care, children who receive the Toddler Oral Health Intervention as add-on care will have a reduced cumulative caries incidence and caries incidence density at the age of 48 months. Methods: This pragmatic, 2-arm, individually randomized controlled trial is being conducted in the Netherlands and has been approved by the Medical Ethics Research Board of University Medical Center Utrecht. Parents with children aged 6 to 12 months attending 1 of the 9 selected well-baby clinics are invited to participate. Only healthy children (ie, not requiring any form of specialized health care) with parents that have sufficient command of the Dutch language and have no plans to move outside the well-baby clinic region are eligible. Both groups receive conventional oral health education in well-baby clinics during regular well-baby clinic visits between the ages of 6 to 48 months. After concealed random allocation of interventions, the intervention group also receives the Toddler Oral Health Intervention from an oral health coach. The Toddler Oral Health Intervention combines behavioral interventions of proven effectiveness in caries prevention. Data are collected at baseline, at 24 months, and at 48 months. The primary study endpoint is cumulative caries incidence for children aged 48 months, and will be analyzed according to the intention-to-treat principle. For children aged 48 months, the balance between costs and effects of the Toddler Oral Health Intervention will be evaluated, and for children aged 24 months, the effects of the Toddler Oral Health Intervention on behavioral determinants, alongside cumulative caries incidence, will be compared. Results: The first parent-child dyads were enrolled in June 2017, and recruitment was finished in June 2019. We enrolled 402 parent-child dyads. Conclusions: All follow-up interventions and data collection will be completed by the end of 2022, and the trial results are expected soon thereafter. Results will be shared at international conferences and via peer-reviewed publication.
LINK
BACKGROUND: Blended physiotherapy, in which physiotherapy sessions and an online application are integrated, might support patients in taking an active role in the management of their chronic condition and may reduce disease related costs. The aim of this study was to evaluate the cost-effectiveness of a blended physiotherapy intervention (e-Exercise) compared to usual physiotherapy in patients with osteoarthritis of hip and/or knee, from the societal as well as the healthcare perspective.METHODS: This economic evaluation was conducted alongside a 12-month cluster randomized controlled trial, in which 108 patients received e-Exercise, consisting of physiotherapy sessions and a web-application, and 99 patients received usual physiotherapy. Clinical outcome measures were quality-adjusted life years (QALYs) according to the EuroQol (EQ-5D-3 L), physical functioning (HOOS/KOOS) and physical activity (Actigraph Accelerometer). Costs were measured using self-reported questionnaires. Missing data were multiply imputed and bootstrapping was used to estimate statistical uncertainty.RESULTS: Intervention costs and medication costs were significantly lower in e-Exercise compared to usual physiotherapy. Total societal costs and total healthcare costs did not significantly differ between groups. No significant differences in effectiveness were found between groups. For physical functioning and physical activity, the maximum probability of e-Exercise being cost-effective compared to usual physiotherapy was moderate (< 0.82) from both perspectives. For QALYs, the probability of e-Exercise being cost-effective compared to usual physiotherapy was 0.68/0.84 at a willingness to pay of 10,000 Euro and 0.70/0.80 at a willingness to pay of 80,000 Euro per gained QALY, from respectively the societal and the healthcare perspective.CONCLUSIONS: E-Exercise itself was significantly cheaper compared to usual physiotherapy in patients with hip and/or knee osteoarthritis, but not cost-effective from the societal- as well as healthcare perspective. The decision between both interventions can be based on the preferences of the patient and the physiotherapist.TRIAL REGISTRATION: NTR4224 (25 October 2013).
DOCUMENT
With ageing, there is a greater risk of dehydration. This study investigated the diuretic effect of alcoholic beverages varying in alcohol concentration in elderly men. Three alcoholic beverages (beer (AB), wine (AW), and spirits (S)) and their non-alcoholic counterparts (non-alcoholic beer (NAB), non-alcoholic wine (NAW), and water (W)) were tested in a diet-controlled randomized crossover trial. For the alcoholic beverages, alcohol intake equaled a moderate amount of 30 g. An equal volume of beverage was given for the non-alcoholic counterpart. After consumption, the urine output was collected every hour for 4 h and the total 24 h urine output was measured. AW and S resulted in a higher cumulative urine output compared to NAW and W during the first 4 h (effect size: 0.25 mL p < 0.003, effect size: 0.18 mL, p < 0.001, respectively), but not after the 24h urine collection (p > 0.40, p > 0.10). AB and NAB did not differ at any time point (effect size: -0.02 mL p > 0.70). For urine osmolality, and the sodium and potassium concentration, the findings were in line. In conclusion, only moderate amounts of stronger alcoholic beverages, such as wine and spirits, resulted in a short and small diuretic effect in elderly men.
DOCUMENT
BACKGROUND: Falls and fall-related injuries among older adults are a serious threat to the quality of life and result in high healthcare and societal costs. Despite evidence that falls can be prevented by fall prevention programmes, practical barriers may challenge the implementation of these programmes. In this study, we will investigate the effectiveness and cost-effectiveness of In Balance, a fourteen-week, low-cost group fall prevention intervention, that is widely implemented in community-dwelling older adults with an increased fall risk in the Netherlands. Moreover, we will be the first to include cost-effectiveness for this intervention. Based on previous evidence of the In Balance intervention in pre-frail older adults, we expect this intervention to be (cost-)effective after implementation-related adjustments on the target population and duration of the intervention.METHODS: This study is a single-blinded, multicenter randomized controlled trial. The target sample will consist of 256 community-dwelling non-frail and pre-frail adults of 65 years or older with an increased risk of falls. The intervention group receives the In Balance intervention as it is currently widely implemented in Dutch healthcare, which includes an educational component and physical exercises. The physical exercises are based on Tai Chi principles and focus on balance and strength. The control group receives general written physical activity recommendations. Primary outcomes are the number of falls and fall-related injuries over 12 months follow-up. Secondary outcomes consist of physical performance measures, physical activity, confidence, health status, quality of life, process evaluation and societal costs. Mixed model analyses will be conducted for both primary and secondary outcomes and will be stratified for non-frail and pre-frail adults.DISCUSSION: This trial will provide insight into the clinical and societal impact of an implemented Dutch fall prevention intervention and will have major benefits for older adults, society and health insurance companies. In addition, results of this study will inform healthcare professionals and policy makers about timely and (cost-)effective prevention of falls in older adults.TRIAL REGISTRATION: Netherlands Trial Register: NL9248 (registered February 13, 2021).
DOCUMENT
BackgroundInterventions to prevent overweight and obesity in toddlers are needed to minimize health inequalities, especially in migration and lower socio-economic groups. Preschools are identified as important environments for interventions to prevent overweight and obesity. Early Childhood Education and Care (ECEC) teachers in preschools are potential key actors in promoting healthy eating and physical activity. This paper describes the research design of a Dutch preschool-based intervention for ECEC teachers in promoting healthy eating and physical activity in toddlers.MethodsPreSchool@HealthyWeight concerns a cluster randomized controlled trial on preschools in Amsterdam Nieuw-West, Netherlands. This city district is characterised by inhabitants with a migration background and low socio-economic status. Forty-one preschools, with 115 ECEC teachers and 249 toddlers/parents, were randomly allocated to an intervention or control group. An intervention for teachers will be carried out on intervention locations and consists of modified versions of 2 existing programs: ‘A Healthy Start’ and ‘PLAYgrounds’. In ‘A Healthy Start’, ECEC teachers learn to provide a healthy and active environment for toddlers. The ‘PLAYgrounds for Toddlers’ program, coaches ECEC teachers to stimulate physical activity in the playgrounds of preschools. PreSchool@HealthyWeight aims to evaluate the effectiveness of the intervention after 9 months. Primary outcomes are the teachers’ knowledge, attitude and practices concerning healthy eating and physical activity, and consequently the level of confidence of ECEC teachers in promoting healthy eating and physical activity in toddlers. Secondary outcomes include the Body Mass Index, body composition, dietary intake and physical activity level of teachers and toddlers. In addition, the activating role of ECEC teachers and the physical activity of toddlers on the playgrounds will be evaluated. Lastly, the knowledge, attitude and practices of parents concerning healthy eating and physical activity will be assessed.DiscussionIt is hypothesized that this preschool-based intervention for ECEC teachers improves the knowledge, attitude and practices regarding healthy eating and physical activity, and consequently the level of confidence of ECEC teachers in promoting healthy eating and physical activity of toddlers. The intervention addresses the call for early intervention to prevent overweight and obesity and to minimize health inequalities.Trial registrationNetherlands Trial Register (NTR): NL5850. Date registered: August 26, 2016.
DOCUMENT
Study goal: This study was carried out to answer the following research question: which motivation do healthy volunteers have to participate in phase I clinical trials? - Methods: A literature search was done through Google Scholar and Academic Search Premier, followed by three interviews with volunteers who had recently concluded their participation in a (non-commercial) phase I trial. - Results: Our literature search revealed mainly commercial motives for volunteers to participate in phase I clinical trials. The interviews (with volunteers in a non-commercial trial) showed that other factors may also play a decisive role, such as: (1) wish to support the investigator (2) wish to contribute to science, (3) access to more/better health care (4) sociability: possibility to relax and to communicate with other participants (5) general curiosity. Precondition is that risks and burden are deemed acceptable. - Conclusions: financial remuneration appears to be the predominant motive to participate voluntarily in a clinical trial. Other reasons were also mentioned however, such as general curiosity, the drive to contribute to science and the willingness to help the investigator. In addition, social reasons were given such as possibility to relax and to meet other people. Potential subjects state that they adequately assess the (safety) risks of participating in a trial as part of their decision process.
DOCUMENT
Background: Medically unexplained symptoms (MUS) are highly prevalent and pose a burden both on patients and on health care. In a pilot study psychosomatic therapy delivered by specialised therapists for patients with MUS showed promising results with regard to patient’s acceptability, feasibility and effects on symptoms. The aim of this study is to establish whether psychosomatic therapy by specialised psychosomatic exercise therapists is costeffective in decreasing symptoms and improving functioning in patients who frequently consult their general practitioner (GP) with MUS. Methods: A randomised effectiveness trial with an economic evaluation in primary care with 158 patients aged 18 years and older who are frequently consulting their GP with MUS. Patients will be assigned to psychosomatic therapy in addition to usual care or usual care only. Psychosomatic therapy is a multi-component and tailored intervention, aiming to empower patients by applying psycho-education, relaxation techniques, mindfulness, cognitive approaches and/or graded activity. Patients assigned to the psychosomatic therapy receive 6 to 12 sessions of psychosomatic therapy, of 30–45 min each, delivered by a specialised exercise or physical therapist. Primary outcome measure is patient-specific functioning and disability, measured with the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are symptom severity, consultation frequency and referrals to secondary care, patient satisfaction, quality of life and costs. Assessments will be carried out at baseline, and after 4 and 12 months. An economic evaluation alongside the trial will be conducted from a societal perspective, with quality-adjusted life years (QALYs) as outcome measure. Furthermore, a mixed-methods process evaluation will be conducted. Discussion: We expect that psychosomatic therapy in primary care for patients who frequently attend the GP for MUS will improve symptoms and daily functioning and disability, while reducing consultation frequency and referrals to secondary care. We expect that the psychosomatic therapy provides value for money for patients with MUS.Trial registration: Netherlands Trial Register, ID: NL7157 (NTR7356). Registered 13 July 2018.Keywords: Psychosomatic therapy, Study protocol, Primary care, Randomised controlled trial, Medically unexplained symptoms, Cost-effectiveness
MULTIFILE
