Dataset Information

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.

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.

SUBMITTER: Van Stappen V

PROVIDER: S-EPMC8252328 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ObjectiveTo describe the design of the Feel4Diabetes-intervention and the baseline characteristics of the study sample.DesignSchool- 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.SettingPrimary schools and municipalities in six European countries.SubjectsFamilies (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).ResultsThe 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.ConclusionsThe 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.

Project description:BackgroundA 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).MethodsParents 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.ResultsMost 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.ConclusionsCountries 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.

Project description:Childhood obesity remains a serious concern in the United States and in many other countries. Direct experience preparing and tasting healthful foods and increasing activity during the school day are promising prevention approaches. Engaging parents and families remains an important challenge. Fuel for Fun: Cooking with Kids Plus Parents and Play is a multi-component school- and family-based intervention for 4th graders and their families intended to promote positive food and activity environments, policies and behaviors at the individual, family and school levels. This paper describes the design and evaluation plan.Four cohorts of 4th-graders and their parents from 8 schools in 2 districts in the same Northern Colorado region are participating in a 4-arm cluster randomized controlled trial. Theory-based Fuel for Fun consists of 5 components delivered over 1 school year: 1) Cooking with Kids - Colorado; an experiential classroom-based cooking and tasting curriculum, 2) Cafeteria Connections; cafeteria-based reinforcements of classroom food experiences using behavioral economic strategies, 3) SPARK active recess; a playground intervention to engage children in moderate to vigorous activity, 4) Fuel for Fun Family; multi-element supports targeting parents to reinforce the 3 school-based components at home, and 5) About Eating; an online interactive program for parents addressing constructs of eating competence and food resource management. Outcomes include child and parent measures of fruit and vegetable preferences and intake, cooking, physical activity, sedentary behaviors and attitudes. School level data assess lunch plate waste and physical activity at recess. In-depth diet and accelerometry assessments are collected with a subsample of parent-child dyads. Data are collected at baseline, immediately post-intervention at 7 months, and at 12 month follow-up. We anticipate recruiting 1320-1584 children and their parents over the length of the project.The Fuel for Fun study design allows for impact assessment of school-, family- and online parent-based intervention components separately and in combination. Study strengths include use of theory- and evidence-based programs, valid child and parent self-report instruments, and objective measures of food, cooking, and physical activity behaviors at the individual, family and school levels. Parent involvement and engagement is examined through multiple strategies.Clinicaltrials.gov registration number NCT02491294 . Registered 7 July, 2015.

Project description:BackgroundThe major efficacy trials on diabetes prevention have used resource-intensive approaches to identify high-risk individuals and deliver lifestyle interventions. Such strategies are not feasible for wider implementation in low- and middle-income countries (LMICs). We aimed to evaluate the effectiveness of a peer-support lifestyle intervention in preventing type 2 diabetes among high-risk individuals identified on the basis of a simple diabetes risk score.Methods and findingsThe Kerala Diabetes Prevention Program was a cluster-randomized controlled trial conducted in 60 polling areas (clusters) of Neyyattinkara taluk (subdistrict) in Trivandrum district, Kerala state, India. Participants (age 30-60 years) were those with an Indian Diabetes Risk Score (IDRS) ?60 and were free of diabetes on an oral glucose tolerance test (OGTT). A total of 1,007 participants (47.2% female) were enrolled (507 in the control group and 500 in the intervention group). Participants from intervention clusters participated in a 12-month community-based peer-support program comprising 15 group sessions (12 of which were led by trained lay peer leaders) and a range of community activities to support lifestyle change. Participants from control clusters received an education booklet with lifestyle change advice. The primary outcome was the incidence of diabetes at 24 months, diagnosed by an annual OGTT. Secondary outcomes were behavioral, clinical, and biochemical characteristics and health-related quality of life (HRQoL). A total of 964 (95.7%) participants were followed up at 24 months. Baseline characteristics of clusters and participants were similar between the study groups. After a median follow-up of 24 months, diabetes developed in 17.1% (79/463) of control participants and 14.9% (68/456) of intervention participants (relative risk [RR] 0.88, 95% CI 0.66-1.16, p = 0.36). At 24 months, compared with the control group, intervention participants had a greater reduction in IDRS score (mean difference: -1.50 points, p = 0.022) and alcohol use (RR 0.77, p = 0.018) and a greater increase in fruit and vegetable intake (?5 servings/day) (RR 1.83, p = 0.008) and physical functioning score of the HRQoL scale (mean difference: 3.9 score, p = 0.016). The cost of delivering the peer-support intervention was US$22.5 per participant. There were no adverse events related to the intervention. We did not adjust for multiple comparisons, which may have increased the overall type I error rate.ConclusionsA low-cost community-based peer-support lifestyle intervention resulted in a nonsignificant reduction in diabetes incidence in this high-risk population at 24 months. However, there were significant improvements in some cardiovascular risk factors and physical functioning score of the HRQoL scale.Trial registrationAustralia and New Zealand Clinical Trials Registry ACTRN12611000262909.

Project description:BackgroundOur objective was to examine whether gestational diabetes mellitus (GDM) or newborns' high birthweight can be prevented by lifestyle counseling in pregnant women at high risk of GDM.Method and findingsWe conducted a cluster-randomized trial, the NELLI study, in 14 municipalities in Finland, where 2,271 women were screened by oral glucose tolerance test (OGTT) at 8-12 wk gestation. Euglycemic (n = 399) women with at least one GDM risk factor (body mass index [BMI] ? 25 kg/m(2), glucose intolerance or newborn's macrosomia (? 4,500 g) in any earlier pregnancy, family history of diabetes, age ? 40 y) were included. The intervention included individual intensified counseling on physical activity and diet and weight gain at five antenatal visits. Primary outcomes were incidence of GDM as assessed by OGTT (maternal outcome) and newborns' birthweight adjusted for gestational age (neonatal outcome). Secondary outcomes were maternal weight gain and the need for insulin treatment during pregnancy. Adherence to the intervention was evaluated on the basis of changes in physical activity (weekly metabolic equivalent task (MET) minutes) and diet (intake of total fat, saturated and polyunsaturated fatty acids, saccharose, and fiber). Multilevel analyses took into account cluster, maternity clinic, and nurse level influences in addition to age, education, parity, and prepregnancy BMI. 15.8% (34/216) of women in the intervention group and 12.4% (22/179) in the usual care group developed GDM (absolute effect size 1.36, 95% confidence interval [CI] 0.71-2.62, p = 0.36). Neonatal birthweight was lower in the intervention than in the usual care group (absolute effect size -133 g, 95% CI -231 to -35, p = 0.008) as was proportion of large-for-gestational-age (LGA) newborns (26/216, 12.1% versus 34/179, 19.7%, p = 0.042). Women in the intervention group increased their intake of dietary fiber (adjusted coefficient 1.83, 95% CI 0.30-3.25, p = 0.023) and polyunsaturated fatty acids (adjusted coefficient 0.37, 95% CI 0.16-0.57, p < 0.001), decreased their intake of saturated fatty acids (adjusted coefficient -0.63, 95% CI -1.12 to -0.15, p = 0.01) and intake of saccharose (adjusted coefficient -0.83, 95% CI -1.55 to -0.11, p ?=? 0.023), and had a tendency to a smaller decrease in MET minutes/week for at least moderate intensity activity (adjusted coefficient 91, 95% CI -37 to 219, p = 0.17) than women in the usual care group. In subgroup analysis, adherent women in the intervention group (n = 55/229) had decreased risk of GDM (27.3% versus 33.0%, p = 0.43) and LGA newborns (7.3% versus 19.5%, p = 0.03) compared to women in the usual care group.ConclusionsThe intervention was effective in controlling birthweight of the newborns, but failed to have an effect on maternal GDM.Trial registrationCurrent Controlled Trials ISRCTN33885819. Please see later in the article for the Editors' Summary.

Project description:Schools have been the main context for physical activity (PA) and sedentary behavior (SB) interventions among adolescents, but there is inconsistent evidence on whether they also improve dimensions of the health-related quality of life (HRQoL). The aim of this study was to evaluate the effects of a school-based active lifestyle intervention on dimensions of HRQoL. A secondary aim was to verify whether sex, age, and HRQoL at baseline were moderators of the intervention effect. A cluster-randomized controlled trial was conducted at three control and three intervention schools in Florianopolis, Brazil. All students from 7th to 9th grade were invited to participate. A school year intervention, designed primarily to increase PA and reduce SB, included strategies focused on (i) teacher training on PA, SB, and nutrition, and availability of teaching materials related to these contents; (ii) environmental improvements (i.e., creation and revitalization of spaces for the practice of PA in school); and (iii) education strategies, with the availability of folders and posters regarding PA, SB, and nutrition. Participants and the research staffs were not blinded to group assignment, but a standardized evaluation protocol was applied at baseline and after the intervention (March and November 2017) using the KIDSCREEN-27 to assess HRQoL across five dimensions. Mixed linear models were performed to evaluate the effect of the Movimente intervention on the five HRQoL dimensions. Of the 921 students who answered the questionnaire at baseline, 300 and 434 completed the study in control and intervention groups, respectively (dropouts: 20%). The results revealed no significant effects of the intervention on any HRQoL dimensions. A reduction of the school environment dimension was observed in both the control (-2.44; 95% CI: -3.41 to -1.48) and intervention groups (-2.09; 95% CI: -2.89 to -1.30). Sensitivity analyses showed that students in the highest baseline tertiles of HRQoL in any dimension had a reduction in their respective scores from pre- to post-intervention in both school groups. In conclusion, our results demonstrated no intervention effect on HRQoL dimensions and those students with the highest levels of HRQoL at baseline on all dimensions reduced from pre to post-intervention.Clinical trial registrationThe trial is registered at the Clinical Trial Registry (Trial ID: NCT02944318; date of registration: October 18, 2016).