Factors affecting continuous participation in follow-up evaluations during a lifestyle intervention programme for type 2 diabetes prevention: The Feel4Diabetes-study.

AIMS: Community- and school-based lifestyle interventions are an efficient method of preventing type 2 diabetes in vulnerable populations. Many participants, however, fail to complete the necessary follow-ups. We investigated factors affecting the continuous participation in follow-up evaluations during the Feel4Diabetes-study, a multilevel intervention programme implemented across Europe. METHODS: Socioeconomic, sociodemographic and clinical factors were assessed for 2702 participants within six participating countries: Bulgaria and Hungary (low-to-middle-income countries, LMIC), Belgium and Finland (high-income countries, HIC) and Greece and Spain (high-income countries under austerity measures, HICAM). RESULTS: Statistically significant differences were detected with respect to sex, control group, education level, employment status, BMI and blood pressure measurements (systolic and diastolic blood pressure). Post hoc analysis revealed significant differences within socioeconomic regions. Higher levels of education were associated with significantly lower attrition in HIC (p < 0.05) and HICAM (p < 0.001), higher employment status was associated with lower attrition in HICAM (p < 0.001) and being female was associated with lower attrition in LMIC (p < 0.001). Surprisingly, the intervention group exhibited higher-than-expected attrition in HIC (p < 0.001) and HICAM (p = 0.003), and lower attrition in LMIC (p = 0.007). When tested together in the same multivariable predictive model, all sociodemographic and socioeconomic variables along with higher BMI retained their statistical significance, while systolic and diastolic blood pressure failed to remain significant. CONCLUSIONS: Key socioeconomic and sociodemographic factors along with BMI play a significant role in determining continuous participation in follow-up evaluations during school- and community-based intervention programmes.

Parental practices and children's lifestyle correlates of childhood overweight/obesity in Europe: The Feel4Diabetes study.

BACKGROUND: Parental influences on children's eating and physical activity (PA) and consequently on their weight are fundamental. The present study aimed to identify the predominant correlates of childhood overweight/obesity among a variety of parental practices and children's lifestyle indices in a large sample of children in Europe. METHODS: Families from low socio-economic status regions were recruited through schools, located in six European countries (Belgium, Finland, Greece, Spain, Bulgaria and Hungary). Seven thousand three hundred ninety-seven children 4-12 years old and their parents were selected using the FINDRISC-questionnaire. Parental practices assessed included parental role modelling, permissiveness and reward. Children's dietary intake and lifestyle behaviours were assessed through parent-reported questionnaires. RESULTS: Regarding parental practices, it was revealed that being sometimes (odds ratio [OR] = 1.26; 95% confidence interval [CI] = 1.10-1.43) or rarely (OR = 1.43; 95% CI = 1.21-1.69) physically active with the child was associated with greater overweight/obesity risk, whereas rare permission of computer/mobile/tablet (OR = 0.81; 95% CI = 0.67-0.98) and sometimes (OR = 0.77; 95% CI = 0.68-0.88) or rare (OR = 0.77; 95% CI = 0.66-0.91) reward with PA were associated with lower risk. Regarding children's lifestyle factors, consuming > 3 cups/week fresh fruit juices (OR = 1.28; 95% CI = 1.13-1.45), skipping breakfast (OR = 1.37; 95% CI = 1.17-1.61), absence of 1 h of daily PA (OR = 1.40; 95% CI = 1.24-1.58) and increased daily screen time (ST) (OR = 1.23; 95% CI = 1.09-1.39) were associated with greater overweight/obesity risk. All the variables were adjusted for maternal education, child's sex and age. CONCLUSIONS: These findings emphasize the necessity of family-centered approaches in health promotion and obesity prevention programs for children. Such programs should focus on parents as the primary role models in exerting positive influence and encouraging healthy eating habits, PA, and ST behaviors in their children, which in turn, may have a substantial impact on children's overall weight status.

A lifestyle pattern characterised by high consumption of sweet and salty snacks, sugar sweetened beverages and sedentary time is associated with blood pressure in families at risk for type 2 diabetes mellitus in Europe. The Feel4Diabetes Study.

BACKGROUND: Individuals from families at high-risk for type 2 diabetes mellitus (T2DM) are also at high risk for hypertension (HTN) and cardiovascular disease. Studies identifying lifestyle patterns (LPs) combining dietary, physical activity or sedentary variables and examining their possible role with respect to developing blood pressure (BP) are limited. The present study aimed to examine the association of different LPs with BP levels in families at high risk for T2DM in Europe. METHODS: In total, 1844 adults (31.6% males) at high-risk for T2DM across six European countries were included in this cross-sectional study using data from the baseline assessment of the Feel4Diabetes Study. BP measurements and dietary and physical activity assessments were conducted, and screen times were surveyed. LPs were revealed with principal component analysis of various data regarding diet, physical activity, screen time and smoking. RESULTS: Three LPs were identified. LP3 (high consumption of sweet and salty snacks, sugar sweetened soft drinks and juices, and high amount of screen time) was positively associated with diastolic BP (B, 0.52; 95% confidence interval = 0.05-0.99) and the existence of HTN (odds ratio = 1.12; 95% confidence interval = 1.00-1.25). Participants in the highest tertile of LP3 spent mean 3 h of screen time, consumed 1.5 portions of sweet and/or salty snacks and 1 L of soft drinks on a daily basis, were associated with 12% higher risk of HTN. CONCLUSIONS: Focusing on the combination of eating and lifestyle behaviours may more accurately identify, and therefore guide preventive measures tailored to the specific needs of high-risk populations.

Contribution of home availability, parental child-feeding practices and health beliefs on children's sweets and salty snacks consumption in Europe: Feel4Diabetes-Study.

Adoption of healthy dietary and snacking habits could support optimum physical and mental development in children as they define health in adulthood. This study assessed parameters associated with children's snacking such as food home availability, parenting practices, and parents' health beliefs. In this cross-sectional study 12 039 children, 49·4% boys 5-12 years, participating in the European Feel4Diabetes-Study were included. Children's weekly consumption of sweets and salty snacks, home availability of snacks, food parenting practices, and health beliefs were assessed via questionnaires. Logistic regression was applied to explore associations of a) home availability of snacks, b) food parenting practices (permissiveness and rewarding with snacks) and c) parent's opinions on deterministic health beliefs with children's consumption of sweets and salty snacks. Results showed that home availability (sweets: ORadj: 4·76, 95 % CI: 4·32, 5·23; salty snacks: ORadj: 6·56, 95 % CI: 5·64, 7·61), allowing to consume (sweets: ORadj: 3·29, 95 % CI: 2·95, 3·67; salty snacks: ORadj: 3·41, 95 % CI: 2·98, 3·90) and rewarding with sweets/salty snacks (sweets: ORadj: 2·69, 95 % CI: 2·23, 3·24; salty snacks: ORadj: 4·34, 95 % CI: 3·57, 5·28) 'sometimes/or less frequently' compared to 'always/or often' were associated with lower weekly consumption of sweets and snacks. Parents' disagreement compared to agreement with deterministic health beliefs and inattentive eating were associated with lower consumption of salty snacks and sweets in children. Overall, the findings of this study indicate that attempts to promote healthy snacking habits in children should aim to improve parental dietary habits, food parenting practices, health beliefs, and reducing home availability of unhealthy foods and snacks.

Self-reported lifestyle behaviours in families with an increased risk for type 2 diabetes across six European countries: a cross-sectional analysis from the Feel4Diabetes-study.

BACKGROUND: A healthy lifestyle decreases the risk of developing type 2 diabetes mellitus. The current cross-sectional study aimed to describe self-reported lifestyle behaviours and compare them to current health guidelines in European Feel4Diabetes-families at risk for developing type 2 diabetes across six countries (Belgium, Finland, Spain, Greece, Hungary and Bulgaria). METHODS: Parents and their children were recruited through primary schools located in low socio-economic status areas. Parents filled out the FINDRISC-questionnaire (eight items questioning age, Body Mass Index, waist circumference, PA, daily consumption of fruit, berries or vegetables, history of antihypertensive drug treatment, history of high blood glucose and family history of diabetes), which was used for the risk assessment of the family. Sociodemographic factors and several lifestyle behaviours (physical activity, sedentary behaviour, water consumption, fruit and vegetable consumption, soft drink consumption, sweets consumption, snack consumption, breakfast consumption) of both adults and children were assessed by parental questionnaires. Multilevel regression analyses were conducted to investigate families' lifestyle behaviours, to compare these levels to health guidelines and to assess potential differences between the countries. Analyses were controlled for age, sex and socio-economic status. RESULTS: Most Feel4Diabetes-families at risk (parents and their children) did not comply with the guidelines regarding healthy behaviours, set by the WHO, European or national authorities. Less than half of parents and children complied with the physical activity guidelines, less than 15% of them complied with the fruit and vegetable guideline, and only 40% of the children met the recommendations of five glasses of water per day. Clear differences in lifestyle behaviours in Feel4Diabetes-families at risk exist between the countries. CONCLUSIONS: Countries are highly recommended to invest in policy initiatives to counter unhealthy lifestyle behaviours in families at risk for type 2 diabetes development, taking into account country-specific needs. For future research it is of great importance to focus on families at risk in order to counter the development of type 2 diabetes and reduce health inequity.

Sociodemographic, anthropometric, and lifestyle correlates of prediabetes and type 2 diabetes in europe: The Feel4Diabetes study.

BACKGROUND AND AIMS: The current work aimed to identify the predominant correlates of prediabetes and T2DM among a variety of socio-demographic, anthropometric and lifestyle indices, in a large sample of adults from families at high risk for T2DM. METHODS AND RESULTS: In this cross-sectional study, 2816 adults were recruited from low-socioeconomic areas in high-income countries (HICs) (Belgium-Finland), HICs under austerity measures (Greece-Spain), and low/middle-income countries (LMICs) (Bulgaria-Hungary). A positive association between the male sex (OR, 95% C.I.2.77 (1.69-4.54)) and prediabetes was revealed compared to females, while there was a negative association between younger age (<45 years) (OR, 95% C.I. 0.58 (0.37-0.92)), and low/medium levels of waist circumference (OR, 95% C.I. 0.44 (0.22-0.89)) with prediabetes compared to older age and high levels of waist circumference, respectively. Concerning T2DM, 0-0.5 cups/day of fruits and berries (OR, 95% C.I.2. 13 (1.16-3.91)) and 150-300 g fish/week (OR, 95% C.I. 2.55 (1.01-6.41)) have a positive association compared to higher consumptions, respectively. Conversely, <1 cup/week legumes (OR, 95% C.I. 0.55 (0.31-0.99) as well as 0-0.5 servings (OR, 95% C.I. 0.34 (0.12-0.95) and 0.5-1 servings (OR, 95% C.I. 0.37 (0.19-0.71) of full-fat dairy/day have a negative association compared to higher consumptions, respectively. CONCLUSION: These findings indicate the need for diabetes prevention measures targeting young adults and especially men, above 45 years of age, with central obesity and poor dietary habits and prioritize vulnerable groups and populations living in LMICs. NATIONAL CLINICAL TRIAL NUMBER: NCT02393872.

Diet quality in association to lipidaemic profile in adults of families at high-risk for type 2 diabetes in Europe: The Feel4Diabetes study.

BACKGROUND AND AIMS: The role of diet in blood lipids is scarcely investigated in adults at risk of Type 2 Diabetes Mellitus (T2DM) and even less studied regarding their socioeconomic status (SES). This study aimed to investigate the associations of diet quality with blood lipids in adults from families at high-risk for developing T2DM from six European countries, considering their SES. METHODS AND RESULTS: In total 2049 adults (67% women) from relatively low-SES regions and high T2DM risk families were enrolled. Dietary habits, sedentary behaviour and sociodemographic characteristics were assessed using standardised questionnaires. The associations of tertiles of healthy diet score (HDS) with blood lipids were tested by univariate analysis of variance (UNIANOVA). HDL-Cholesterol (HDL-C) was positively (B 1.54 95%CI 0.08 to 2.99) and LDL-Cholesterol (LDL-C) (B -4.15 95%CI -7.82 to -0.48), ratio of total cholesterol to HDL-C (B -0.24 95%CI -0.37 to -0.10), ratio of LDL-C to HDL-C (B -0.18 95%CI -0.28 to -0.08) and Atherogenic Index of Plasma (B -0.03 95%CI -0.06 to 0.00) inversely associated with the highest tertile of diet score compared to the lowest tertile independently of age, sex, Body Mass Index, total screen time and smoking. In sub-analysis of education (<14 and ≥ 14 years of education), these findings were only significant in the high-SES group. CONCLUSION: While diet quality was poorer in the low-SES group, an association between diet quality and lipidemic profile was not found, as increased central obesity and smoking prevalence might have confounded this association. These findings indicate the need for tailor-made interventions, guided by the specific risk factors identified per population sub groups.

Parental insulin resistance is associated with unhealthy lifestyle behaviours independently of body mass index in children: The Feel4Diabetes study.

Parental health is associated with children's health and lifestyles. Thus, the aim of the present study was to assess lifestyle behaviours of children of parents with insulin resistance (IR) and at risk of type 2 diabetes. 2117 European families from the Feel4Diabetes-study were identified as being at risk for diabetes with the FINDRISC questionnaire and included in the present study. One parent and one child per family were included. Parental IR was considered when homeostasis model assessment (HOMA) was equal or higher than 2.5. Children's screen-time, physical activity and diet were assessed and clustered by K-means. Weight and height were measured and children's body mass index (BMI) was calculated. For children, a Healthy Diet Score (HDS) was calculated. Linear regression and multilevel logistic regression analyses were performed to assess the associations between parental IR and children's lifestyle behaviours in 2021. Children of parents with IR had higher BMI (p < 0.001) and spent more screen time (p = 0.014) than those of non-IR parents. Children of parents with IR had a lower value in the breakfast and vegetable components of the HDS (p = 0.008 and p = 0.05). Four lifestyle clusters were found. Children of IR parents had higher odds of being in a non-healthy cluster (OR: 1.19; 95%CI: 1.001-1.437). CONCLUSION: Having an IR parent was associated with a high screen time and an increased probability of having an unhealthy lifestyle pattern in children. These data point out that children's lifestyles should be assessed in families with IR parents to provide tailored interventions. WHAT IS KNOWN: • Children with diabetic or insulin-resistant parents could also develop this condition. • Unhealthy lifestyles are directly related with insulin resistance even in children. WHAT IS NEW: • Children from parents with insulin resistance have higher chances of unhealthy lifestyles. • A higher BMI was found for those children with an insulin-resistant parent.

Can food parenting practices explain the association between parental education and children's food intake? The Feel4Diabetes-study.

OBJECTIVE: This study aimed to investigate the mediating role of food parenting practices (FPP), including home availability of different types of foods and drinks, parental modelling of fruit intake, permissiveness and the use of food as a reward in the relationship between parental education and dietary intake in European children. DESIGN: Single mediation analyses were conducted to explore whether FPP explain associations between parents' educational level and children's dietary intake measured by a parent-reported FFQ. SETTING: Six European countries. PARTICIPANTS: Parent-child dyads (n 6705, 50·7 % girls, 88·8 % mothers) from the Feel4Diabetes-study. RESULTS: Children aged 8·15 ± 0·96 years were included. Parental education was associated with children's higher intake of water, fruits and vegetables and lower intake of sugar-rich foods and savoury snacks. All FPP explained the associations between parental education and dietary intake to a greater or lesser extent. Specifically, home availability of soft drinks explained 59·3 % of the association between parental education and sugar-rich food intake. Home availability of fruits and vegetables was the strongest mediators in the association between parental education and fruit and vegetable consumption (77·3 % and 51·5 %, respectively). Regarding savoury snacks, home availability of salty snacks and soft drinks was the strongest mediators (27·6 % and 20·8 %, respectively). CONCLUSIONS: FPP mediate the associations between parental education and children's dietary intake. This study highlights the importance of addressing FPP in future interventions targeting low-educated populations.

Fathers' daily intake of fruit and vegetables is positively associated with children's fruit and vegetable consumption patterns in Europe: The Feel4Diabetes Study.

BACKGROUND: Past research has focused on the relationship between mothers' and children's eating habits, although little is known about fathers as potential agents. The present study aimed to investigate the relationship between fathers' and children's fruit and vegetable (FV) intake in the context of fathers' education level and family income insecurity. METHODS: Cross-sectional analysis using baseline data from the multicentre Feel4Diabetes Study were collected in 2016. Participants were parent-dyads (fathers, n = 10,038) and school children (n = 12,041) from six European countries. Socio-demographic and dietary data were collected using questionnaires. Associations were assessed applying the multinomial logistic regression model. RESULTS: Overall, European children have low FV intake, especially in Southern European countries (Greece, Spain and Hungary). Children with fathers consuming FV daily were more likely to consume fresh fruit (odds ratio [OR] = 2.75; 95% confidence interval [CI] = 1.95-3.88) and vegetables (OR = 2.55; 95% CI = 1.80-3.60) 1-2 times per day. After adjusting for paternal educational level and family income insecurity significant associations remained for fresh fruit (ORadj = 2.59; 95% CI = 1.82-3.69) and vegetables (ORadj = 1.98; 95% CI = 1.38-2.86). Country differences showed that fathers' educational level and income insecurity might be important factors worth considering for FV intake in Greece. CONCLUSIONS: The present study showed that fathers' FV intake was positively associated with children's daily intake of these foods. Implementation of future population-based strategies promoting FV intake not only in mothers, but also in fathers could be an effective public health initiative to increase FV intake in children. Policy-makers should give special attention to families dwelling in Southern European regions.

The Feel4Diabetes intervention: effectiveness on 24-hour physical behaviour composition in families at risk for diabetes development.

The Feel4Diabetes project conducted a 2-year intervention aiming to encourage healthy behaviours in families in six European countries. Within this paper, the intervention effect was evaluated after the first intervention year on 24-hour physical behaviour composition in Belgian families at risk for type 2 diabetes. Parents' and children's levels of physical activity (PA) and sedentary behaviour (SB) were objectively measured and sleep duration was self-reported. Valid data were obtained in 82 children (mean age: 8.2 ± 0.84; 50.0% boys) and 72 parents (mean age: 40.1 ± 5.5; 27.8% fathers). Data were analysed using a compositional data approach, and mixed models were used to take clustering into account. Results showed that for children, the mean baseline composition of the 24-hour day in sleep, SB, light and moderate-to-vigorous PA for the intervention group was (11 hours 18 minutes; 6 hours 33 minutes; 5 hours 02 minutes, 1 hour 08 minutes) and for the control group (11 hours 18 minutes; 6 hours 35 minutes; 5 hours 04 minutes; 1 hour 06 minutes), respectively. For parents, the mean baseline composition was for the intervention group (8 hours 12 minutes; 9 hours 36 minutes; 5 hours 43 minutes; 27 minutes) and for the control group (8 hours 00 minute; 9 hours 00 minute; 6 hours 27 minutes; 33 minutes). No significant intervention effects were found on 24-hour physical behaviour composition of either parents or children (p = 0.19 and p = 0.21, respectively). A relatively small study population and a poor attendance rate among parents could maybe explain the lack of effectiveness. More effective strategies are needed to retain vulnerable families in interventions. Furthermore, future approaches to improve the 24-hour physical behaviour composition should maybe focus more specifically on PA, SB and sleep, and involve teachers, children and parents in the design of the intervention. Trial registration: NCT02393872 in ClinicalTrials.gov.

The effect of a cluster-randomized controlled trial on lifestyle behaviors among families at risk for developing type 2 diabetes across Europe: the Feel4Diabetes-study.

BACKGROUND: This study investigated the effect of the Feel4Diabetes-intervention, a 2-year multilevel intervention, on energy balance-related behaviors among European families at risk for developing type 2 diabetes. Intervention effects on self-reported physical activity, sedentary behavior and eating behaviors were investigated across and within the participating countries: Belgium, Finland, Greece, Spain, Hungary and Bulgaria. METHODS: Families were recruited through schools, located in low socio-economic status areas. In total, 4484 families at risk for developing type 2 diabetes were selected using the FINDRISC-questionnaire. Parents' and children's energy balance-related behaviors data were collected by questionnaires at three time points (baseline, mid- and post intervention). Families assigned to the intervention group were invited to participate in a 2-year school-, community-, and family-based intervention to promote a healthier lifestyle, including counseling sessions (first intervention year) and text messages (second intervention year). Families assigned to the control group received standard care, including medical check-up results and recommendations and tips regarding a healthy lifestyle. To assess the intervention-effects, Mixed Models were conducted using the R-Package "lmer "with R v3.2. RESULTS: Significant intervention effects were found on a certain number of families' lifestyle behaviors. Significant favorable intervention effects were detected on parents' water consumption and consumption of fruit and vegetables, and on children's consumption of sweets and moderate-to-vigorous physical activity. Analyses by country revealed significant favorable intervention effects on water consumption and on moderate-to-vigorous physical activity in Belgian parents and on fruit and vegetable consumption among Belgian children, on sweets consumption among Spanish parents and children, and on moderate-to-vigorous physical activity among Finnish children. Unfavorable intervention effects were found on the consumption of soft drinks and sugar-containing juices among Hungarian children and parents, while when examining the intervention effects for the overall population and per country, 10 from the 112 investigated outcome variables were improved in the intervention group compared to the control group (9%). CONCLUSIONS: The Feel4Diabetes-intervention managed to improve a certain number of targeted lifestyle behaviors while the intervention was not effective on a large number of targeted lifestyle behaviors. The findings of the current study are encouraging, but further research is needed on how we can further improve effectiveness of lifestyle interventions to prevent type 2 diabetes in families at risk. TRIAL REGISTRATION: The Feel4Diabetes-study is registered with the clinical trials registry http://clinicaltrials.gov , ID: 643708.

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.

Effective strategies for childhood obesity prevention via school based, family involved interventions: a critical review for the development of the Feel4Diabetes-study school based component.

BACKGROUND: Although there are many interventions targeting childhood obesity prevention, only few have demonstrated positive results. The current review aimed to gather and evaluate available school-based intervention studies with family involvement targeting dietary, physical activity and sedentary behaviors among primary schoolchildren and their families, in order to identify the most effective strategies. METHODS: Studies published between 2000 and January 2015 were retrieved from scientific electronic databases and grey literature. The databases used included MEDLINE/PubMed, Web-of-Science, CINAHL and Scopus. Included studies had to be experimental controlled studies and had duration over 1 school year, had family involvement, combined PA and dietary behaviors and were implemented in school setting. A complementary search was executed to update the review to cover the period from February 2015 to January 2019. RESULTS: From the studies examined (n = 425), 27 intervention programs (33 publications) fulfilled the inclusion criteria. Among these, 15 presented significant effect on weight status and/ or overweight/ obesity or clinical indices, 3 presented significant effect on most energy balance-related behaviors (EBRBs) while 9 presented significant effect on some/few EBRBs or determinants. Strategies implemented in effective interventions were: teachers acting as role-models and being actively involved in the delivery of the intervention, school policies supporting the availability of healthy food and beverage choices and limiting unhealthy snacks, changes in the schoolyard, in the recess rules and in the physical education classes to increase physical activity, and involving parents in the intervention via assignments, meetings, informative material and encouraging them to improve the home environment. Use of incentives for children, social marketing techniques, collaboration with local stakeholders were found to increase effectiveness. Programs that focused only on educational sessions and material for parents, without promoting relevant environmental and policy changes, were found to be less effective. Cultural adaptations have been suggested to increase the intervention's acceptance in specific or vulnerable population groups. CONCLUSIONS: Several effective strategies were identified in the reviewed programs. Outcomes of the current review were taken into account in developing the Feel4Diabetes-intervention and summed up as recommendations in the current work in order to facilitate other researchers designing similar childhood obesity prevention initiatives.

Feel4Diabetes healthy diet score: development and evaluation of clinical validity.

BACKGROUND: The aim of this paper is to present the development of the Feel4Diabetes Healthy Diet Score and to evaluate its clinical validity. METHODS: Study population consisted of 3268 adults (63% women) from high diabetes risk families living in 6 European countries. Participants filled in questionnaires at baseline and after 1 year, reflecting the dietary goals of the Feel4Diabetes intervention. Based on these questions the Healthy Diet Score was constructed, consisting of the following components: breakfast, vegetables, fruit and berries, sugary drinks, whole-grain cereals, nuts and seeds, low-fat dairy products, oils and fats, red meat, sweet snacks, salty snacks, and family meals. Maximum score for each component was set based on its estimated relative importance regarding T2DM risk, higher score indicating better quality of diet. Clinical measurements included height, weight, waist circumference, heart rate, blood pressure, and fasting blood sampling, with analyses of glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides. Analysis of (co) variance was used to compare the Healthy Diet Score and its components between countries and sexes using baseline data, and to test differences in clinical characteristics between score categories, adjusted for age, sex and country. Pearson's correlations were used to study the association between changes from baseline to year 1 in the Healthy Diet Score and clinical markers. To estimate reproducibility, Pearson's correlations were studied between baseline and 1 year score, within the control group only. RESULTS: The mean total score was 52.8 ± 12.8 among women and 46.6 ± 12.8 among men (p <  0.001). The total score and its components differed between countries. The change in the Healthy Diet Score was significantly correlated with changes in BMI, waist circumference, and total and LDL cholesterol. The Healthy Diet Score as well as its components at baseline were significantly correlated with the values at year 1, in the control group participants. CONCLUSION: The Feel4Diabetes Healthy Diet Score is a reproducible method to capture the dietary information collected with the Feel4Diabetes questionnaire and measure the level of and changes in the adherence to the dietary goals of the intervention. It gives a simple parameter that associates with clinical risk factors in a meaningful manner. TRIAL REGISTRATION: Clinicaltrials.gov NCT02393872. Registered March 20, 2015.

Two-stage, school and community-based population screening successfully identifies individuals and families at high-risk for type 2 diabetes: the Feel4Diabetes-study.

BACKGROUND: The implementation of population screening and early prevention strategies targeting individuals at high-risk for type 2 diabetes (T2D) seems to be a public health priority. The current work aimed to describe the screening procedure applied in the Feel4Diabetes-study and examine its effectiveness in identifying individuals and families at high risk, primarily for T2D and secondarily for hypertension, among vulnerable populations in low to middle-income countries (LMICs) and high-income countries (HICs) across Europe. METHODS: A two-stage screening procedure, using primary schools as the entry-point to the community, was applied in low socioeconomic status (SES) regions in LMICs (Bulgaria-Hungary), HICs (Belgium-Finland) and HICs under austerity measures (Greece-Spain). During the first-stage screening via the school-setting, a total of 20,501 parents (mothers and/or fathers) of schoolchildren from 11,396 families completed the Finnish Diabetes Risk Score (FINDRISC) questionnaire, while their children underwent anthropometric measurements in the school setting. Parents from the identified "high-risk families" (n = 4484) were invited to participate in the second-stage screening, including the measurement of fasting plasma glucose (FPG) and blood pressure (BP). In total, 3153 parents participated in the second-stage screening (mean age 41.1 ± 5.6 years, 65.8% females). RESULTS: Among parents who attended the second-stage screening, the prevalence of prediabetes (as defined by impaired fasting glucose; FPG 100-125 mg/dl) and T2D (FPG > 126 mg/dl) was 23.2 and 3.0% respectively, and it was found to be higher in the higher FINDRISC categories. The percentage of undiagnosed T2D among the participants identified with T2D was 53.5%. The prevalence of high normal BP (systolic BP 130-139 mmHg and/ or diastolic BP 85-89 mmHg) and hypertension (systolic BP ≥ 140 mmHg and/ or diastolic BP ≥ 90 mmHg) was 14 and 18.6% respectively, which was also higher in the higher FINDRISC categories. The percentage of cases not receiving antihypertensive treatment among the participants identified with hypertension was 80.3%. CONCLUSION: The findings of the current study indicate that the two-stage school and community-based screening procedure followed, effectively identified high-risk individuals and families in vulnerable populations across Europe. This approach could be potentially scalable and sustainable and support initiatives for the early prevention of T2D and hypertension. TRIAL REGISTRATION: The Feel4Diabetes-intervention is registered at https://clinicaltrials.gov/ (NCT02393872; date of trial registration: March 20, 2015).

Sociodemographic and lifestyle-related risk factors for identifying vulnerable groups for type 2 diabetes: a narrative review with emphasis on data from Europe.

BACKGROUND: Type 2 diabetes mellitus (T2DM) comprises the vast majority of all diabetes cases in adults, with alarmingly increasing prevalence over the past few decades worldwide. A particularly heavy healthcare burden of diabetes is noted in Europe, where 8.8% of the population aged 20-79 years is estimated to have diabetes according to the International Diabetes Federation. Multiple risk factors are implicated in the pathogenesis of T2DM with complex underlying interplay and intricate gene-environment interactions. Thus, intense research has been focused on studying the role of T2DM risk factors and on identifying vulnerable groups for T2DM in the general population which can then be targeted for prevention interventions. METHODS: For this narrative review, we conducted a comprehensive search of the existing literature on T2DM risk factors, focusing on studies in adult cohorts from European countries which were published in English after January 2000. RESULTS: Multiple lifestyle-related and sociodemographic factors were identified as related to high T2DM risk, including age, ethnicity, family history, low socioeconomic status, obesity, metabolic syndrome and each of its components, as well as certain unhealthy lifestyle behaviors. As Europe has an increasingly aging population, multiple migrant and ethnic minority groups and significant socioeconomic diversity both within and across different countries, this review focuses not only on modifiable T2DM risk factors, but also on the impact of pertinent demographic and socioeconomic factors. CONCLUSION: In addition to other T2DM risk factors, low socioeconomic status can significantly increase the risk for prediabetes and T2DM, but is often overlooked. In multinational and multicultural regions such as Europe, a holistic approach, which will take into account both traditional and socioeconomic/socioecological factors, is becoming increasingly crucial in order to implement multidimensional public health programs and integrated community-based interventions for effective T2DM prevention.

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.

Obtaining evidence base for the development of Feel4Diabetes intervention to prevent type 2 diabetes - a narrative literature review.

BACKGROUND: Feel4Diabetes was a school and community based intervention aiming to promote healthy lifestyle and tackle obesity for the prevention of type 2 diabetes among families in 6 European countries. We conducted this literature review in order to guide the development of evidence-based implementation of the Feel4Diabetes intervention. We focused on type 2 diabetes prevention strategies, including all the phases from risk identification to implementation and maintenance. Special focus was given to prevention among vulnerable groups and people under 45 years. METHODS: Scientific and grey literature published between January 2000 and January 2015 was searched for relevant studies using electronic databases. To present the literature review findings in a systematic way, we used the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. A complementary literature search from February 2015 to December 2018 was also conducted. RESULTS: The initial review included 27 studies with a follow-up ≥12 months and 9 studies with a follow-up ≥6 months and with a participant mean age < 45 years. We found out that interventions should be targeted at people at risk to improve recruiting and intervention effectiveness. Screening questionnaires (primarily Finnish Diabetes Risk Score FINDRISC) and blood glucose measurement can both be used for screening; the method does not appear to affect intervention effectiveness. Screening and recruitment is time-consuming, especially when targeting lower socioeconomic status and age under 45 years. The intervention intensity is more important for effectiveness than the mode of delivery. Moderate changes in several lifestyle habits lead to good intervention results. A minimum of 3-year follow-up seemed to be required to show a reduction in diabetes risk in high-risk individuals. In participants < 45 years, the achieved results in outcomes were less pronounced. The complementary review included 12 studies, with similar results regarding intervention targets and delivery modes, as well as clinical significance. CONCLUSION: This narrative review highlighted several important aspects that subsequently guided the development of the Feel4Diabetes high-risk intervention. Research on diabetes prevention interventions targeted at younger adults or vulnerable population groups is still relatively scarce. Feel4Diabetes is a good example of a project aiming to fill this research gap. TRIAL REGISTRATION: clinicaltrials.gov NCT02393872, registered 20th March 2015.