Chronic kidney disease (CKD) has a rising global prevalence and is expected to become the fifth leading cause of death by 2030. Increased albuminuria defines the early stages of CKD and is among the ...strongest risk factors for progressive CKD and cardiovascular disease. The value of population screening for albuminuria to detect CKD in an early phase has yet to be studied. We aimed to evaluate the effectiveness of two home-based albuminuria population screening methods.
Towards Home-based Albuminuria Screening (THOMAS) was a prospective, randomised, open-label implementation study that invited Dutch adults aged 45–80 years for albuminuria screening. Individuals were randomly assigned (1:1) to screening by applying either a urine collection device (UCD) that was sent by post to a central laboratory for measurement of the albumin-to-creatinine ratio (ACR) by immunoturbidimetry or to screening via a smartphone application that measures the ACR with a dipstick method at home. Randomisation was done with a four-block method via a web-based system and was stratified by age, sex, and socioeconomic status. If two or more individuals per household were invited to participate, these individuals were randomly assigned to the same group. In case of confirmed increased albuminuria at home, participants were invited for an elaborate screening in a regional hospital (Amphia Hospital, Breda, Netherlands) for CKD and cardiovascular risk factors. When abnormalities were found, participants were referred to their general practitioner for treatment. The primary outcomes were the participation rate and yield of the home-based screening and elaborate screening. Participation rate was assessed in the intention-to-screen population (ie, all participants who were invited for the home-based screening or elaborate screening). Yield was assessed in the per-protocol population (ie, all individuals who participated in the home-based screening or elaborate screening). An exploratory analysis assessed the sensitivity and specificity of both home-based screening methods. To this end, an additional quantitative ACR test was performed among people participating in the elaborate screening, and a substudy was performed among participants with a first negative home-based screening test, who were invited for an additional test. The study is registered with ClinicalTrials.gov, NCT04295889.
15 074 participants were enrolled between Nov 14, 2019, and March 19, 2021. 7552 (50·1%) were randomly assigned to home-based albuminuria screening by the UCD method and 7522 (49·9%) were assigned to albuminuria screening by the smartphone application method. The participation rate of the home-based screening was 4484 (59·4% 95% CI 58·3–60·5) of the 7552 invited individuals for the UCD method and 3336 (44·3% 43·2–45·5) of 7522 invited individuals for the smartphone application method (p<0·0001). Increased ACR was confirmed by home-based testing in 150 (3·3% 95% CI 2·9–3·9) of 4484 individuals for the UCD method and 171 (5·1% 4·4–5·9) of 3336 indivduals for the smartphone application method. 124 (82·7% 95% CI 75·8–87·9) of 150 individuals assigned to the UCD method and 142 (83·0% 76·7–87·9) of 171 participants assigned to the smartphone application method attended the elaborate screening. Sensitivity to detect increased ACR was 96·6% (95% CI 91·5–99·1) for the UCD method and 98·1% (89·9–99·9) for the smartphone application method, and specificity was 97·3% (94·7–98·8) for the UCD method and 67·9% (62·0–73·3) for the smartphone application method, indicating that the test characteristics of only the UCD method were sufficient for screening. Albuminuria, hypertension, hypercholesterolaemia, and decreased kidney function were newly diagnosed in 77 (62·1%), 44 (35·5%), 30 (24·2%), and 27 (21·8%) of 124 participants for the UCD method, respectively. Of the 124 participants assigned to the UCD method who completed elaborate screening, 111 (89·5%) were referred to their general practitioner for treatment because of newly diagnosed CKD or cardiovascular disease risk factors or known risk factors outside the target range.
Home-based screening of the general population for increased ACR using a UCD had a high participation rate and correctly identified individuals with increased albuminuria and yet unknown or known but outside target range CKD and cardiovascular risk factors. By contrast, the smartphone application method had a lower at-home participation rate than the UCD method and the test specificity was too low to accurately assess individuals for risk factors during the elaborate screening. The UCD screening strategy could allow for an early start of treatment to prevent progressive kidney function loss and cardiovascular disease in patients with CKD.
Dutch Kidney Foundation, Top Sector Life Sciences & Health of the Dutch Ministry of Economic Affairs.
Chronic kidney disease (CKD) is a rising public health problem that may progress to kidney failure, requiring kidney replacement therapy. It is also associated with an increased incidence of ...cardiovascular disease (CVD). Because of its asymptomatic nature, CKD is often detected in a late stage. Population screening for albuminuria could allow early detection of people with CKD who may benefit from preventive treatment. In case such screening is performed in a general practitioner (GP) setting, this will result in relatively high costs. Home-based screening might be an effective and cost-effective alternative.
The THOMAS study (Towards HOMe-based Albuminuria Screening) is designed to prospectively investigate two methods for home-based population screening for increased albuminuria to detect yet undiagnosed CKD and risk factors for progression and CVD.
This investigator initiated, randomized population-based study will include 15.000 individuals aged 45-80 years, who will be randomly assigned to be invited for a home-based screening test for albuminuria with a more conventional urine collection device or an innovative smartphone application. If the test result is positive upon confirmation (i.e., elevated albuminuria), participants are invited to a central screening facility for an elaborate screening for CKD and CVD risk factors. Participants are referred to their GP for appropriate treatment, if abnormalities are found. Primary endpoints are the participation rate, yield, and cost-effectiveness of the home-based screening and elaborate screening.
The THOMAS study will evaluate the effectiveness and cost-effectiveness of home-based albuminuria screening in the general population for the early detection of CKD and CVD risk factors. It will provide insight into the willingness to participate in population screening for CKD and into the compliance of the general population to a corresponding screening protocol and compliance to participate. Thus, it may help to develop an attractive novel screening strategy for the early detection of CKD.
ClinicalTrials.gov, registration number NCT04295889, registered 05 March 2020. https://www.google.com/search?client=firefox-b-d&q=NCT04295889.
The aim of the current study was to compare levels of energy balance-related behaviours (physical activity, sedentary behaviour, and dietary behaviours (more specifically water consumption, ...sugar-sweetened beverage consumption and unhealthy snacking)) in four- to six-year-old preschoolers from six European countries (Belgium, Bulgaria, Germany, Greece, Poland, and Spain) within the ToyBox cross-sectional study.
A sample of 4,045 preschoolers (4.77 ± 0.43 years; 52.2% boys) had valid physical activity data (steps per day), parents of 8,117 preschoolers (4.78 ± 0.46 years; 53.0% boys) completed a parental questionnaire with questions on sedentary behaviours (television viewing, computer use, and quiet play), and parents of 7,244 preschoolers (4.77 ± 0.44 years; 52.0% boys) completed a food frequency questionnaire with questions on water consumption, sugar-sweetened beverage consumption and unhealthy snacking.
The highest levels of physical activity were found in Spain (12,669 steps/day on weekdays), while the lowest levels were found in Bulgaria and Greece (9,777 and 9,656 steps/day on weekdays, respectively). German preschoolers spent the least amount of time in television viewing (43.3 min/day on weekdays), while Greek preschoolers spent the most time in television viewing (88.5 min/day on weekdays). A considerable amount of time was spent in quiet play in all countries, with the highest levels in Poland (104.9 min/day on weekdays), and the lowest levels in Spain (60.4 min/day on weekdays). Belgian, German, and Polish preschoolers had the lowest intakes of water and the highest intakes of sugar-sweetened beverages. The intake of snacks was the highest in Belgian preschoolers (73.1 g/day) and the lowest in Greek preschoolers (53.3 g/day).
Across six European countries, differences in preschoolers' energy balance-related behaviours were found. Future interventions should target European preschoolers' energy balance-related behaviours simultaneously, but should apply country-specific adaptations.
The development of the ToyBox‐intervention was based on the outcomes of the preliminary phase of the ToyBox‐study, aiming to identify young children's key behaviours and their determinants related to ...early childhood obesity. The ToyBox‐intervention is a multi‐component, kindergarten‐based, family‐involved intervention with a cluster‐randomized design, focusing on the promotion of water consumption, healthy snacking, physical activity and the reduction/ breaking up of sedentary time in preschool children and their families. The intervention was implemented during the academic year 2012–2013 in six European countries: Belgium, Bulgaria, Germany, Greece, Poland and Spain. Standardized protocols, methods, tools and material were used in all countries for the implementation of the intervention, as well as for the process, impact, outcome evaluation and the assessment of its cost‐effectiveness. A total sample of 7,056 preschool children and their parents/caregivers, stratified by socioeconomic level, provided data during baseline measurements and participated in the intervention. The results of the ToyBox‐study are expected to provide a better insight on behaviours associated with early childhood obesity and their determinants and identify effective strategies for its prevention. The aim of the current paper is to describe the design of the ToyBox‐intervention and present the characteristics of the study sample as assessed at baseline, prior to the implementation of the intervention.
The ToyBox‐intervention is a kindergarten‐based, family‐involved intervention targeting multiple lifestyle behaviours in preschool children, their teachers and their families. This intervention was ...conducted in six European countries, namely Belgium, Bulgaria, Germany, Greece, Poland and Spain. The aim of this paper is to provide a descriptive overview of the harmonization and standardization procedures of the baseline and follow‐up evaluation of the study (and substudies). Steps related to the study's operational, standardization and harmonization procedures as well as the impact and outcome evaluation assessment tools used are presented. Experiences from the project highlight the importance of safeguarding the measurement process to minimize data heterogeneity derived from potential measurement error and country‐by‐country differences. In addition, it was made clear that continuing quality control and support is an important component of such studies. For this reason, well‐supported communication channels, such as regular email updates and teleconferences, and regular internal and external meetings to ensure smooth and accurate implementation were in place during the study. The ToyBox‐intervention and its harmonized and standardized procedures can serve as a successful case study for future studies evaluating the efficacy of similar interventions.
The ToyBox‐study aims to develop and test an innovative and evidence‐based obesity prevention programme for preschoolers in six European countries: Belgium, Bulgaria, Germany, Greece, Poland and ...Spain. In multicentre studies, anthropometric measurements using standardized procedures that minimize errors in the data collection are essential to maximize reliability of measurements. The aim of this paper is to describe the standardization process and reliability (intra‐ and inter‐observer) of height, weight and waist circumference (WC) measurements in preschoolers. All technical procedures and devices were standardized and centralized training was given to the fieldworkers. At least seven children per country participated in the intra‐ and inter‐observer reliability testing. Intra‐observer technical error ranged from 0.00 to 0.03 kg for weight and from 0.07 to 0.20 cm for height, with the overall reliability being above 99%. A second training was organized for WC due to low reliability observed in the first training. Intra‐observer technical error for WC ranged from 0.12 to 0.71 cm during the first training and from 0.05 to 1.11 cm during the second training, and reliability above 92% was achieved. Epidemiological surveys need standardized procedures and training of researchers to reduce measurement error. In the ToyBox‐study, very good intra‐ and‐inter‐observer agreement was achieved for all anthropometric measurements performed.
Reliable assessments of health‐related behaviours are necessary for accurate evaluation on the efficiency of public health interventions. The aim of the current study was to examine the reliability ...of a self‐administered primary caregivers questionnaire (PCQ) used in the ToyBox‐intervention. The questionnaire consisted of six sections addressing sociodemographic and perinatal factors, water and beverages consumption, physical activity, snacking and sedentary behaviours. Parents/caregivers from six countries (Belgium, Bulgaria, Germany, Greece, Poland and Spain) were asked to complete the questionnaire twice within a 2‐week interval. A total of 93 questionnaires were collected. Test–retest reliability was assessed using intra‐class correlation coefficient (ICC). Reliability of the six questionnaire sections was assessed. A stronger agreement was observed in the questions addressing sociodemographic and perinatal factors as opposed to questions addressing behaviours. Findings showed that 92% of the ToyBox PCQ had a moderate‐to‐excellent test–retest reliability (defined as ICC values from 0.41 to 1) and less than 8% poor test–retest reliability (ICC < 0.40). Out of the total ICC values, 67% showed good‐to‐excellent reliability (ICC from 0.61 to 1). We conclude that the PCQ is a reliable tool to assess sociodemographic characteristics, perinatal factors and lifestyle behaviours of pre‐school children and their families participating in the ToyBox‐intervention.
Process evaluation (PE) is used for the in‐depth evaluation of the implementation process of health promotion programmes. The aim of the current paper was to present the PE design and tools used in ...the ToyBox‐intervention. The PE design was based on a three‐step approach, including the identification of ToyBox‐specific PE elements (step 1), the development of PE tools and harmonization of procedures (step 2), and the implementation of PE using standardized protocol and tools across the intervention countries (step 3). Specifically, to evaluate the implementation of the intervention, teachers' monthly logbooks were recorded (dose delivered, fidelity, dose received); post‐intervention questionnaires were completed by parents/caregivers and teachers (dose received); participation and attrition rates were recorded (recruitment, reach); and audit questionnaires and retrospective information on weather conditions were collected (physical and social environment within which the intervention was implemented). Regarding the teachers' training sessions, the researchers who performed the trainings completed evaluation forms and documented teachers' attendance after each training (dose delivered, fidelity, dose received) and teachers completed evaluation forms after each training (dose received). The PE performed in the ToyBox‐intervention may contribute in the evaluation of its effectiveness, guide the revision of the intervention material and provide insights for future health promotion programmes and public health policy.
BACKGROUND: The ToyBox-study developed an evidence- and theory-based intervention to improve preschoolers’ energy balance-related behaviours – including physical activity (PA) – by targeting the ...kindergarten environment and involving their parents/caregivers. The present study aimed to examine the effect of the ToyBox-intervention on increasing Belgian preschoolers’ objectively measured PA levels. METHODS: A sample of 472 preschoolers (4.43 ± 0.55 years; 55.1% boys) from 27 kindergartens (15 intervention, 12 control kindergartens) in Flanders, Belgium were included in the data analyses. Preschoolers wore an ActiGraph accelerometer for six consecutive days and were included in the data analyses if they had a minimum of two weekdays and one weekend day, both at baseline and follow-up (one year later). Preschoolers’ PA outcomes were estimated for an average day, weekday, weekend day, during school hours, and during after school hours. To assess intervention effects, multilevel repeated measures analyses were conducted for the total sample, and for sub-groups (according to sex, kindergarten levels of socio-economic status (SES) and risk groups (low levels of PA at baseline)) of preschoolers. RESULTS: Small intervention effects were found in the total sample. Most intervention effects were found in boys and in preschoolers from high SES kindergartens. Boys from the intervention group had an increase in vigorous PA (ß = 1.47, p = 0.03) and moderate-to-vigorous PA (ß = 1.27, p = 0.03) from baseline to follow-up, whereas PA levels in boys from the control group stagnated or decreased. In preschoolers from high SES kindergartens, the largest effects were found for PA outcomes during school hours and during after school hours. CONCLUSION: The results from the Belgian sample demonstrate that effects of the PA-component of the ToyBox-intervention on objectively measured PA were found in preschool boys and in preschoolers from high SES kindergartens, which means that the ToyBox-intervention was mainly effective in those sub-groups. Future interventions should search for alternative strategies to increase preschoolers’ PA levels in preschool girls and preschoolers from low SES kindergartens, as these are the most important at-risk groups regarding PA.
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