A brief description and preliminary results of the Feel4Diabetes study

A brief description of the Feel4Diabetes study

Feel4Diabetes is an EU-funded study (HORIZON2020), under GACD (https://www.gacd.org/research-projects/diabetes/dm08) with a duration of 5 years (2015-2019). Feel4Diabetes is an ongoing evidence-based and potentially cost-effective and scalable 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 from vulnerable groups in six European countries (Figure 1). Vulnerable groups were defined as the overall population in low/middle–income countries (LMICs; Bulgaria, Hungary), families from low-socioeconomic neighbourhoods in high-income countries (HICs; Belgium, Finland) and countries under austerity measures (Greece, Spain). The Feel4Diabetes multidisciplinary consortium incorporates the necessary expertise on diabetes prevention, behavioural science, nutrition, physical activity, policy and health economics. It consists of 10 partners: 7 universities, 1 research institute, 1 advocacy group and 1 small-medium enterprise, representing European low-middle income, high income and under austerity measures countries. Using the school setting as an entry point to the community, the Feel4Diabetes-study reached approximately 30,000 children and their families from 221 schools in the six “intervention” countries. Participating families went through a two-stage organized screening (Figure 2). The 1st stage screening was delivered via the school setting with the completion of a self-reported screening tool (i.e. FINDRISC questionnaire) completed by the parents, where more than 12,000 families (one or two parents from each family and at least one child) were actually screened (Table 1). From this screening, 4,513 parents were identified with FINDRISC >10 and referred in a discrete manner for the 2nd stage screening (a more detailed medical checkup) and invited to attend a series of counseling sessions delivered in local community health centers. Some preliminary results from the Fee4Diabetes-study are presented below. Feel4Diabetes-intervention was implemented for two school years (2016-17 and 2017-18) and included two components; the “all-families” component and the “high-risk families” component. The “all-families” intervention component was implemented via the school setting by the primary school teachers and in collaboration with the local municipalities targeting all children and their families from the participating schools. The aim of this intervention component was to create a more supportive physical and social environment within the school and the community and promote a healthy and active lifestyle for all children and their families. For the needs of this component the ToyBox school-based family-involved intervention was adapted to better serve the local contextual circumstances in each intervention country. The “high-risk families” intervention component was targeting only the high-risk families as identified from the 1st screening. These families were invited, in a discrete manner in order to avoid stigmatization of the child and the family, to attend counselling sessions delivered by trained health care professionals in any available local community settings. The number of counselling sessions delivered during the 1st school year was six, while during the 2nd school year one counselling session was delivered followed by a motivational text-message mobile intervention. This component was built on experience and learnings from previous face-to-face and mobile application interventions.

Preliminary results of the Feel4Diabetes study

The following data provide a brief update of the Feel4Diabetes-study’s key achievements during the first two years of the programme’s implementation (2015-2017):
  • A total population of more than 2 million was reached in the participating municipalities
  • More than 20,000 parents were screened
  • 4,513 parents were identified as "high-risk" based on a calculated FINDRISC score>10
  • A total of 3,148 parents and 121 grandparents participated in the medical check-up at baseline
  • 40.6% of parents with type 2 diabetes were previously undetected
  • 62.6% of parents with hypertension were previously undetected
Regarding the two components of the intervention:
  • The “all-families” intervention component was delivered to more than 17,000 children and their families in the classes of participating schools
  • The “high-risk families” intervention component was delivered to more than 1,100 families
"All-families" intervention component: Brief overview of the Feel4Diabetes-study preliminary baseline data (Spring 2016) A total number of 12,192 primary school children (1-3rd grade) were screened in all six countries. Their baseline characteristics are presented in Table 2 below. The prevalence of overweight and obesity as obtained for the children from the participating schools and municipalities are shown in Figure 3. The mean prevalence of overweight and obesity from all six countries was found to be 25.6% with 18.1% of the children being overweight while the 7.5% being obese. The highest prevalence of overweight and obesity among children was observed in Greece (36.5%) while the lowest in Belgium (14.3%).

Figure 3 Frequency of overweight/ obesity in children by country

  When grouping the countries by region, i.e. high income countries (HICs) under austerity measures: Greece & Spain, low to middle income countries (LMICs): Bulgaria & Hungary and high income countries (HICs): Belgium & Finland, it is notable that HICs under austerity measures have the highest prevalence of overweight and obesity while HICs have the lowest, as presented in Figure 4.

Figure 4 Frequency of overweight/ obesity in children by region

  Figure 5 shows the prevalence of overweight and obesity among children from the participating schools by region and by their mother’s educational level. Children with more educated mothers show lower percentages of overweight and obesity.

Figure 5 Frequency of overweight/ obesity in children by region and mother’s educational level

  Figure 6 shows the prevalence of overweight and obesity among children from the participating schools by region and by their mother’s FINDRISC score. Children whose mothers have FINDRISC score below 10 show lower percentages of overweight and obesity.

Figure 6 Frequency of overweight/ obesity in children by region and mother’s FINDRISC score

  Figure 7 shows the prevalence of overweight and obesity among children from the participating schools by region and by their mother’s weight status. Children whose mothers are normal weight show lower percentages of overweight and obesity in comparison to those who have overweight or obese mothers.

Figure 7 Frequency of overweight/ obesity in children by region and mother’s weight status

  Figure 8 shows the prevalence of overweight and obesity among parents from the participating schools and municipalities by region based on self-reported data from 12,192 families. Mothers show lower percentages of overweight and obesity in comparison to fathers in all regions.

Figure 8 Frequency of overweight/ obesity (based on self-reported data) in parents by region

  "High-risk families" intervention component: Brief overview of the Feel4Diabetes-study preliminary baseline data (Spring 2016) Based on the 1st screening, families that were found to be at high risk for type 2 diabetes were invited to participate in the 2nd screening and the “high-risk families” intervention component. From the total number of 4,513 adults found to be at high risk, all were invited to participate and 3,148 parents and 121 grandparents actually attended the 2nd screening. Parents’ baseline characteristics are presented in Table 3 below. Figure 9 shows the prevalence of overweight and obesity among mothers and fathers based on measured data from 3,148 high risk adults by region. Mothers show lower percentages of overweight and obesity in comparison to fathers in all regions.

Figure 9 Frequency of overweight/ obesity in High Risk adults (mothers and fathers) by region

  Figure 10 shows the prevalence of: High Normal Blood Pressure, Grade 1, Grade 2 and Grade 3 hypertension among parents from the high risk families by region and by their FINDRISC score. Parents who have FINDRISC score below 10 show lower percentages of High Normal Blood Pressure, Grade 1, Grade 2 and Grade 3 hypertension in comparison to those with higher FINDRISC scores. The cut-offs are based on the ESH/ESC Guidelines1.

Figure 10 Frequency of blood pressure levels in High Risk adults by FINDRISC category

  Figure 11 shows the prevalence of elevated blood pressure & hypertension among parents from the high risk families by region. The elevated blood pressure category includes the participants with Normal and High Normal Blood Pressure (diastolic blood pressure ≥120 & systolic blood pressure ≥80), while the hypertension category includes the participants with Grade 1, Grade 2 and Grade 3 hypertension (diastolic blood pressure ≥140 & systolic blood pressure ≥90). The cut-offs are based on the ESH/ESC Guidelines1.

Figure 11 Frequency of elevated blood pressure & hypertension

  Figure 12 shows the prevalence of pre-diabetes and diabetes among parents from the high risk families by region. The cut-offs are based on the WHO Guidelines2.

Figure 12 Frequency of pre-diabetes & diabetes in High Risk adults by region

  Figure 13 shows the prevalence of hypercholesterolemia among parents from the high risk families by region. The cut-offs are based on the national cholesterol education program (NCEP) Report3.

Figure 13 Frequency of hypercholesterolemia in High Risk adults by region

  Figure 14 shows the prevalence of undiagnosed diabetic cases within total diabetic participants among parents from the high risk families by region. The cut-offs are based on the WHO Guidelines2.

Figure 14 Frequency of undiagnosed diabetic cases within total diabetic participants in High Risk adults by region

  Figure 15 shows the prevalence of undiagnosed cases with hypertension within total hypertensive participants among parents from the high risk families by region. The cut-offs are based on the ESH/ESC Guidelines1.

Figure 15 . Frequency of undiagnosed cases with hypertension within total hypertensive subjects in High Risk adults by region.

  "High-risk families" intervention component: Brief overview of the preliminary results regarding the Feel4Diabetes-study impact (2016-2017) The 1st year of the “high-risk families” intervention component was implemented during the school year 2016-2017. In order to evaluate the impact of the 1st year of the Feel4Diabetes implementation, baseline results (obtained in spring 2016) and follow-up 1 results (obtained in spring 2017) are presented below based on the available cleaned data so far.   Based on the preliminary results obtained from two intervention countries, namely Greece and Bulgaria, the 1st year of Feel4Diabetes intervention managed to demonstrate a significant impact on preventing new cases of HTN and T2D (Table 4 and Table 5). Specifically, 34.4% out of the 131 pre-diabetic parents in Greece and 53.1% out of the 32 pre-diabetic parents in Bulgaria managed to improve their health status and reach normal blood glucose levels after one year of intervention4. In the same context, 42.2% out of the 99 pre-hypertensive parents in Greece and 34.1% out of the 87 pre-hypertensive parents in Bulgaria managed to reach normal blood pressure at the end of 1st year’s intervention. "High-risk families" intervention component: Brief overview of the preliminary results regarding the Feel4Diabetes-study effect on health indices for parents and their children (2016-2017) Based on preliminary data analysis using the available and cleaned data at that time obtained in Greece, at the end of the first year of the intervention it was revealed that both parents and children in the intervention municipalities were benefited compared to the control municipalities regarding several anthropometrical and biochemical indices examined5. Specifically, for high risk families, significant mean effects for parents were observed on: waist circumference (-0.10 cm vs. 1.59 cm, p<0.001), total and LDL cholesterol (-6.28 mg/dL vs. 5.59 mg/dL, p<0.001 and -5.44 mg/dL vs. 3.24 mg/dL, p<0.001, respectively), the prevalence of hypercholesterolemia (-8.5% vs. 1.1%, p= 0.034) and the prevalence of insulin resistance measured using HOMA-IR (0.7% vs. 6.5%, p=0.042). In children for high-risk families, significant favorable mean effects were observed on BMI (0.59 kg/m2 vs. 0.79 kg/m2, p= 0.033) for both genders and BMI z-score for girls only (-0.03 vs. 0.09, p= 0.024). The current preliminary outcomes revealed that the first year of the feel4diabetes intervention appears to have favorable effects on a wide range of anthropometric and biochemical indices for both children and their parents in Greece. Certainly, further analyses including data from all participating countries, as well as the follow up examination after the completion of the second year of intervention will reveal important learnings for the effectiveness, cost-effectiveness and potential scalability of the feel4diabetes intervention.
    1. G. Mancia et al. 2013 ESH/ESC Guidelines for the managemenτ of arterial hypertension; European Heart Journal (2013) 34, 2159–2219 doi:10.1093/eurheartj/eht151
    2. Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia : report of a WHO/IDF consultation. Geneva, World Health Organization 2006
    3. Third report of the national cholesterol education program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III) final report. Circulation 2002; 106:3143–421
    4. Manios Y et al. Undiagnosed Diabetes And Hypertension Among Young Adults With Increased Diabetes Risk In A Large-Scale European Cohort: Feel4diabetes Study. European Diabetes Epidemiology Group (EDEG) Annual Meeting; 2018; Elsinore, Denmark
    5. Manios Y et al. Preliminary Outcomes Of The 1st Year Of An Intervention Aiming To Promote Healthy Lifestyle In A Large-Scale European Cohort: Feel4diabetes Study. European Diabetes Epidemiology Group Annual Meeting; 2018; Elsinore, Denmark
The Feel4Diabetes-study has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement n° 643708. Total EU contribution: 2,997,405 euros Project Coordinator: Prof. Yannis Manios, Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University European Commission’s link for the Feel4Diabetes-study: https://cordis.europa.eu/project/rcn/194094_en.html GACD link for the Feel4Diabetes-study: https://www.gacd.org/research-projects/diabetes/dm08