Socioeconomic vulnerabilities and food intake in European children: The Feel4Diabetes Study.

OBJECTIVES: Socioeconomic inequalities create substantial burdens influencing children's health status and diet quality. The aim of this study was to investigate the association between cumulative socioeconomic vulnerabilities and differences in the food intake of children. METHODS: This was a cross-sectional analysis of baseline data from 12 041 European parent-child dyads (children were 5-12 y of age with 49% boys) enrolled in the Feel4 Diabetes study. Parents completed standardized questionnaires to record details on socioeconomic status (SES), demographic, and children's frequency of food and beverage intake. Vulnerable groups were defined as children whose parents had <12 y of education, were unemployed, or reported difficult household income security. A cumulative SES vulnerability score (range 0-4) was created by adding the number of vulnerabilities a child was exposed to. RESULTS: Logistic regression showed that children with the highest SES vulnerability score were less likely to consume water (odds ratio [OR], 0.42; 95% confidence interval [CI], 0.30-0.59), fresh fruit (OR, 0.66; 95% CI, 0.56-0.78) and vegetables (OR, 0.67; 95% CI, 0.56-0.81) daily in comparison with those with no SES vulnerabilities, whereas they were more likely to consume canned fruit (OR, 2.30; 95% CI, 1.64-3.24), fruit juice (OR, 1.42; 95% CI, 1.14-1.77), soft drinks (regular: OR, 4.85; 95% CI, 3.85-6.10; diet: OR, 4.81; 95% CI, 3.28-7.06), and salty snacks/fast food (OR, 3.92; 95% CI, 3.05-5.04) daily, after adjusting for children's age, sex, country, and weight status. CONCLUSION: The findings of this study highlighted that an unhealthy dietary profile was characteristic of European children in families with a high number of SES vulnerabilities. School-based public health programs promoting healthy eating in children should prioritize families with cumulative SES vulnerabilities.

Cost-effectiveness analysis of a school- and community-based intervention to promote a healthy lifestyle and prevent type 2 diabetes in vulnerable families across Europe: the Feel4Diabetes-study.

The Feel4Diabetes-study implemented a school- and community-based intervention to promote healthy lifestyle and prevent type 2 diabetes mellitus (T2DM) in six European countries. The intervention included a special focus on families at increased T2DM risk. The current study evaluates the intervention's cost-effectiveness. A Markov-type health economic model was developed to predict the incidence of T2DM and its complications. Incremental cost-effectiveness ratios (lifetime horizon, societal perspective) were calculated based on the overall intervention effect on health behaviour, and stratified for low- and high-risk families. Sensitivity analyses captured input parameters uncertainty. A budget impact analysis was performed. The increase in children's water consumption and physical activity led to a modest gain in quality adjusted life years (QALYs) at a low intervention cost and budget impact. Medical cost savings due to avoided illness could only be achieved on the very long-term (>30 years). The intervention in its entirety was cost-effective (more QALYs at a reasonable investment) in Belgium, Finland, Bulgaria, and Hungary, while being dominant (net savings and more QALYs) in Greece and Spain. Results were cost-effective for the low-risk families, who only received the school- and community-based intervention component. Results for the high-risk families were only cost-effective (with considerable uncertainty) in Greece and Spain, but not when the intervention would need to be repeated. The Feel4Diabetes-intervention is potentially cost-effective, especially in countries with a high overweight and obesity prevalence, at a limited budget impact. The incremental financial investments to reach and support high-risk families did not result in the hoped-for health benefits.

Development and reliability of questionnaires for the assessment of diet and physical activity behaviors in a multi-country sample in Europe the Feel4Diabetes Study.

BACKGROUND: Assessment of diet and physical activity and their determinants still remains a demanding task, especially when the objective is to evaluate the efficacy of lifestyle interventions. In the context of the Feel4Diabetes study (a European community based intervention study in families with school aged children and at high risk of developing diabetes), we aimed to develop questionnaires for the assessment of food-frequency and eating behaviors, and physical activity and sedentary behaviors in both parents and school-aged children and a questionnaire for overall family's energy balance-related behaviors. METHODS: Questionnaires were developed to be used in 6 countries under standardized harmonization procedures and included questions regarding not only food intake and physical activity, but also questions of their determinants. A reliability study was conducted in 191 pairs of parents and their children (N = 191). Parents completed the questionnaires on two occasions, within a 1-2 week interval. Reliability was tested by the intra-class correlation coefficients (ICC) of test-retest. RESULTS: Most of the questions in all questionnaires had excellent reliability, assessed as an ICC of > 0.810. Mean ICCs for food-frequency and eating behaviors questionnaires were 0.838 and 0.787, and for physical activity and sedentary behaviors questionnaires were 0.734 and 0.793, in adults and children respectively. Mean ICC for overall family's energy balance-related behaviors and their determinants was 0.659. CONCLUSION: The developed questionnaires showed acceptable reliability and may be valuable tools in the assessment of children's and parents' behaviors related to diet, physical activity, sedentary behavior and overall energy balance in school- and community-based interventions.

Methodology of the health economic evaluation of the Feel4Diabetes-study.

BACKGROUND: The clinical and economic burden of type 2 diabetes mellitus on society is rising. Effective and efficient preventive measures may stop the increasing prevalence, given that type 2 diabetes mellitus is mainly a lifestyle-driven disease. The Feel4Diabetes-study aimed to tackle unhealthy lifestyle (unhealthy diet, lack of physical activity, sedentary behaviour, and excess weight) of families with a child in the first grades of elementary school. These schools were located in regions with a relatively low socio-economic status in Belgium, Bulgaria, Finland, Greece, Hungary and Spain. Special attention was paid to families with a high risk of developing type 2 diabetes mellitus. METHODS: The aim of this paper is to describe the detailed methodology of the intervention's cost-effectiveness analysis. Based on the health economic evaluation of the Toybox-study, both a decision analytic part and a Markov model have been designed to assess the long-term (time horizon of 70 year with one-year cycles) intervention's value for money. Data sources used for the calculation of health state incidences, transition probabilities between health states, health state costs, and health state utilities are listed. Intervention-related costs were collected by questionnaires and diaries, and attributed to either all families or high risk families only. CONCLUSIONS: The optimal use of limited resources is pivotal. The future results of the health economic evaluation of the Feel4Diabetes-study will contribute to the efficient use of those resources.

Intra- and inter- observer reliability of anthropometric measurements and blood pressure in primary schoolchildren and adults: the Feel4Diabetes-study.

BACKGROUND: Feel4Diabetes was a large-scale, multicenter lifestyle intervention aiming to prevent type 2 diabetes among families from vulnerable population groups in six European countries (Belgium, Bulgaria, Finland, Greece, Hungary and Spain). The current study aimed to describe the process that was followed to harmonize and standardize the measurement of anthropometric (weight, height and waist circumference) and blood pressure (systolic and diastolic) indices, as well as to assess the intra- and inter- observer reliability of these measurements. METHODS: A central training workshop was conducted prior to the baseline measurements of the Feel4Diabetes-intervention. One researcher from each intervention country, as well as 12 adults and 12 children (for the anthropometric measurements) and 21 adults (for the blood pressure measurements) participated in this workshop. Technical Error of Measurement (TEM) and reliability (%R) were calculated to assess the reliability of the indices which were assessed to evaluate the outcome of the Feel4Diabetes-intervention. The Feel4Diabetes-intervention is registered at https://clinicaltrials.gov/ (NCT02393872). RESULTS: Intra-observer reliability was found to be higher than 99.5% for all anthropometric measurements in both children and adults. Inter-observer reliability was found to be higher than 98% regarding the anthropometric measurements, while for blood pressure measurements %R was 76.62 and 91.38% for systolic and diastolic blood pressure measurements, respectively. CONCLUSION: The central training of the Fee4Diabetes-intervention ensured that the data collected for the outcome evaluation of the Feel4Diabetes-intervention in the six European countries at three different time points (baseline, follow-up 1 and follow-up 2) were valid and comparable.

Barriers from Multiple Perspectives Towards Physical Activity, Sedentary Behaviour, Physical Activity and Dietary Habits When Living in Low Socio-Economic Areas in Europe. The Feel4Diabetes Study.

This study investigated barriers towards health behaviours (physical activity, limiting sedentary behaviour and healthy dietary habits) experienced by young European families living in vulnerable areas, from multiple perspectives (parents, teachers, local community workers). Focus groups were conducted in six European countries (Belgium, Bulgaria, Finland, Hungary, Greece and Spain). In each country, three focus groups were conducted with parents, one with teachers and one with local community workers. Data were analysed using a deductive framework approach with a manifest content analysis using the software NVivo. The present study identified barriers on four levels (individual, interpersonal, organisational and macro level) of a socio-ecological model of health behaviour. From parents' perspectives, both general barriers (e.g., financial limitations and lack of time) and country-specific barriers (e.g., organisational difficulties and inappropriate work environment) were identified. Additional barriers (e.g., lack of parental knowledge and lack of parental skills) were provided by other stakeholders (i.e., teachers and local community workers). The results of this study demonstrate the additional value of including multiple perspectives when developing a lifestyle intervention aiming to prevent type 2 diabetes in vulnerable groups. Future lifestyle interventions are recommended to include multiple components (family, school, and community) and could be implemented across European countries if country-specific adaptations are allowed.

A school- and community-based intervention to promote healthy lifestyle and prevent type 2 diabetes in vulnerable families across Europe: design and implementation of the Feel4Diabetes-study.

OBJECTIVE: To describe the design of the Feel4Diabetes-intervention and the baseline characteristics of the study sample. DESIGN: School- and community-based intervention with cluster-randomized design, aiming to promote healthy lifestyle and tackle obesity and obesity-related metabolic risk factors for the prevention of type 2 diabetes among families from vulnerable population groups. The intervention was implemented in 2016-2018 and included: (i) the 'all-families' component, provided to all children and their families via a school- and community-based intervention; and (ii) an additional component, the 'high-risk families' component, provided to high-risk families for diabetes as identified with a discrete manner by the FINDRISC questionnaire, which comprised seven counselling sessions (2016-2017) and a text-messaging intervention (2017-2018) delivered by trained health professionals in out-of-school settings. Although the intervention was adjusted to local needs and contextual circumstances, standardized protocols and procedures were used across all countries for the process, impact, outcome and cost-effectiveness evaluation of the intervention. SETTING: Primary schools and municipalities in six European countries. SUBJECTS: Families (primary-school children, their parents and grandparents) were recruited from the overall population in low/middle-income countries (Bulgaria, Hungary), from low socio-economic areas in high-income countries (Belgium, Finland) and from countries under austerity measures (Greece, Spain). RESULTS: The Feel4Diabetes-intervention reached 30 309 families from 236 primary schools. In total, 20 442 families were screened and 12 193 'all families' and 2230 'high-risk families' were measured at baseline. CONCLUSIONS: The Feel4Diabetes-intervention is expected to provide evidence-based results and key learnings that could guide the design and scaling-up of affordable and potentially cost-effective population-based interventions for the prevention of type 2 diabetes.