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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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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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Lifestyle Changes Observed among Adults Participating in a Family- and Community-Based Intervention for Diabetes Prevention in Europe: The 1st Year Results of the Feel4Diabetes-Study.
Manios, Y, Lambrinou, CP, Mavrogianni, C, Cardon, G, Lindström, J, Iotova, V, Tankova, T, Rurik, I, Stappen, VV, Kivelä, J, et al
Nutrients. 2020;(7)
Abstract
The Feel4Diabetes intervention was a school and community-based intervention aiming to promote healthy lifestyle and tackle obesity and obesity-related metabolic risk factors for the prevention of type 2 diabetes (T2D) among families at risk of developing this disease. The current study aims to present the results on lifestyle behaviors obtained from parents during the first year of the Feel4Diabetes intervention. This multicomponent intervention had a cluster randomized design and was implemented in Belgium, Bulgaria, Finland, Greece, Hungary and Spain over two years (2016-2018). Standardized protocols and procedures were used by the participating centers in all countries to collect data on parents' lifestyle behaviors (diet, physical activity, sedentary behavior). The Feel4Diabetes intervention was registered at clinicaltrials.gov (registration number: NCT02393872). In total, 2110 high-risk parents participated in the baseline and 12-month follow-up examination measurements. Participants allocated to the intervention group reduced their daily consumption of sugary drinks (p = 0.037) and sweets (p = 0.031) and their daily screen time (p = 0.032), compared with the control group. In addition, participants in the intervention group in Greece and Spain increased their consumption of breakfast (p = 0.034) and fruits (p = 0.029), while in Belgium and Finland they increased their water intake (p = 0.024). These findings indicate that the first year of the Feel4Diabetes intervention resulted in the improvement of certain lifestyle behaviors in parents from high-risk families.
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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.