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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.
Van Stappen, V, Cardon, G, De Craemer, M, Mavrogianni, C, Usheva, N, Kivelä, J, Wikström, K, De Miquel-Etayo, P, González-Gil, EM, Radó, AS, et al
The international journal of behavioral nutrition and physical activity. 2021;(1):86
Abstract
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.
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Sociodemographic and lifestyle-related risk factors for identifying vulnerable groups for type 2 diabetes: a narrative review with emphasis on data from Europe.
Kyrou, I, Tsigos, C, Mavrogianni, C, Cardon, G, Van Stappen, V, Latomme, J, Kivelä, J, Wikström, K, Tsochev, K, Nanasi, A, et al
BMC endocrine disorders. 2020;20(Suppl 1):134
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Type 2 diabetes mellitus (T2DM) results from progressive loss of insulin secretion, which is typically combined with various degrees of insulin resistance. The aim of this study is to provide a comprehensive overview of key sociodemographic and lifestyle-related risk factors for identifying vulnerable groups for T2DM with emphasis on data from Europe. This study is a narrative review which includes 101 publications. Literature shows that prevention of T2DM should be a collaborative effort which mobilizes multiple partners/ stakeholders at a national and international (e.g. European) level. In addition, a holistic approach is becoming increasingly essential in order to put into effect multidimensional public health programs and integrated interventions for effective T2DM prevention which will take into account both traditional and socioeconomic/socioecological factors. Authors conclude that a multidimensional approach for the prevention of T2DM may have a broader impact against the current diabesity epidemic within and across countries in Europe.
Abstract
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.
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Development and reliability of questionnaires for the assessment of diet and physical activity behaviors in a multi-country sample in Europe the Feel4Diabetes Study.
Anastasiou, CA, Fappa, E, Zachari, K, Mavrogianni, C, Van Stappen, V, Kivelä, J, Virtanen, E, González-Gil, EM, Flores-Barrantes, P, Nánási, A, et al
BMC endocrine disorders. 2020;(Suppl 1):135
Abstract
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.
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Obtaining evidence base for the development of Feel4Diabetes intervention to prevent type 2 diabetes - a narrative literature review.
Kivelä, J, Wikström, K, Virtanen, E, Georgoulis, M, Cardon, G, Civeira, F, Iotova, V, Karuranga, E, Ko, W, Liatis, S, et al
BMC endocrine disorders. 2020;(Suppl 1):140
Abstract
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.
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Effectiveness of a family-, school- and community-based intervention on physical activity and its correlates in Belgian families with an increased risk for type 2 diabetes mellitus: the Feel4Diabetes-study.
Huys, N, Van Stappen, V, Shadid, S, De Craemer, M, Androutsos, O, Wikström, K, Makrilakis, K, Moreno, LA, Iotova, V, Tankova, T, et al
BMC public health. 2020;(1):1231
Abstract
BACKGROUND The study aimed to investigate the effectiveness of the European Feel4Diabetes intervention, promoting a healthy lifestyle, on physical activity and its correlates among families at risk for type 2 diabetes mellitus (based on the Finnish Diabetes Risk Score) in Belgium. METHODS The Feel4Diabetes intervention involved three components: family, school and community component, with the family component consisting of 6 counseling sessions for families at risk. Main outcomes were objectively measured physical activity levels and its subjectively measured correlates. The final sample consisted of 454 parents (mean age 39.4 years; 72.0% women) and 444 children (mean age 8.0 years; 50.1% girls). Multilevel repeated measures analyses were performed to assess intervention effectiveness after 1 year. RESULTS In parents, there was no significant intervention effect. In children, there were only significant negative effects for moderate to vigorous physical activity (p = 0.05; ηp2 = 0.008) and steps (p = 0.03; ηp2 = 0.006%) on weekdays, with physical activity decreasing (more) in the intervention group. CONCLUSIONS The F4D-intervention lacks effectiveness on high-risk families' physical activity and its correlates in Belgium. This could partially be explained by low attendance rates and a large drop-out. To reach vulnerable populations, future interventions should invest in more appropriate recruitment (e.g. more face-to-face contact) and more bottom-up development of the intervention (i.e. co-creation of the intervention with the target group). TRIAL REGISTRATION The Feel4Diabetes-study was prospectively registered at clinicaltrials.gov as NCT02393872 on 20 March 2015.
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Intra- and inter- observer reliability of anthropometric measurements and blood pressure in primary schoolchildren and adults: the Feel4Diabetes-study.
Androutsos, O, Anastasiou, C, Lambrinou, CP, Mavrogianni, C, Cardon, G, Van Stappen, V, Kivelä, J, Wikström, K, Moreno, LA, Iotova, V, et al
BMC endocrine disorders. 2020;(Suppl 1):27
Abstract
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.
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Effect of integrating a video intervention on parenting practices and related parental self-efficacy regarding health behaviours within the Feel4Diabetes-study in Belgian primary schoolchildren from vulnerable families: A cluster randomized trial.
Van Stappen, V, De Lepeleere, S, Huys, N, Latomme, J, Verloigne, M, Cardon, G, Androutsos, O, Manios, Y, De Bourdeaudhuij, I, De Craemer, M
PloS one. 2019;(12):e0226131
Abstract
BACKGROUND This study aimed to investigate the effect of integrating a video intervention "Movie Models" within the Feel4Diabetes-study on specific parenting practices and related parental self-efficacy regarding children's physical activity, screen-time and eating behaviour in vulnerable families (i.e. families living in low socioeconomic municipalities and at risk for developing type 2 diabetes). Additionally, there was examination of how the intervention was perceived by the parents. METHODS Within randomly selected low socioeconomic municipalities in Belgium, families were recruited through primary schools. Families at risk for developing type 2 diabetes were identified using the FINDRISC questionnaire (n = 457). Afterwards, the municipalities were randomly assigned to the intervention or control condition. At risk families assigned to the intervention group were invited to participate in six Feel4Diabetes counselling sessions in which families were encouraged to adopt a healthier lifestyle. The "Movie Models" videos were integrated within two sessions by using a face-to-face group discussion approach. Parenting-related factors were assessed before and after the integration of the videos, using a questionnaire. After integrating the videos, some extra evaluation questions were assessed. In total, 126 families were included in a per protocol evaluation and Repeated Measures ANOVAs were conducted to evaluate the potential intervention effects. RESULTS Some favourable intervention effects were found on parenting practices and related parental self-efficacy regarding children's eating behaviours, however almost no effects were found on parenting-related factors regarding children's physical activity and screen-time. In total, 60.0% of the participants indicated that they applied tips regarding parenting practices and 52.0% indicated that discussions with other participants regarding the videos were useful for them. CONCLUSION The integration of "Movie Models" within the Feel4Diabetes-study was effective in improving some parenting-related factors regarding children's health behaviours, however most parenting-related factors could not be improved. The implementation of "Movie Models" as a face-to-face group discussion approach was relatively well received and may be a promising way to improve parenting-related factors in vulnerable families. TRIAL REGISTRATION ClinicalTrials.gov NCT02278809.