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Combining Effect and Process Evaluation on European Preschool Children's Snacking Behavior in a Kindergarten-Based, Family-Involved Cluster Randomized Controlled Trial: The ToyBox Study.
De Craemer, M, Verbestel, V, Verloigne, M, Androutsos, O, Moreno, L, Iotova, V, Koletzko, B, Socha, P, Manios, Y, Cardon, G
International journal of environmental research and public health. 2020;(19)
Abstract
This study aimed at (1) studying the effect of the standardized ToyBox intervention on European preschoolers' snacking behavior, and (2) studying whether a higher process evaluation score from teachers and parents/caregivers was associated with a more positive result for preschoolers' snack intake. A sample of 4970 preschoolers (51.4% boys, 4.74 ± 0.44 years) from six European countries provided information on snack intake with the use of a Food Frequency Questionnaire. To investigate the effect of the intervention, multilevel repeated measures analyses were executed for the total sample and the six country-specific samples. Furthermore, questionnaires to measure process evaluation were used to compute a total process evaluation score for teachers and parents/caregivers. No significant intervention effects on preschoolers' snack intake were found (all p > 0.003). In general, no different effects of the intervention on snack intake were found according to kindergarten teachers' and parents'/caregivers' process evaluation scores. The lack of effects could be due to limited intervention duration and dose. To induce larger effects on preschoolers' snack intake, a less standardized intervention which is more tailored to the local needs might be needed.
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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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Mediators of the Effectiveness of an Intervention Promoting Water Consumption in Preschool Children: The ToyBox Study.
Lambrinou, CP, van Stralen, MM, Androutsos, O, Moreno, LA, Iotova, V, Socha, P, Koletzko, B, De Bourdeaudhuij, I, Manios, Y
The Journal of school health. 2018;(12):877-885
Abstract
BACKGROUND The ToyBox-intervention has increased preschool children's water consumption. This study aimed to examine if family-related determinants mediate the effects of the ToyBox-intervention on preschoolers' water consumption. METHODS Overall, 6290 preschoolers and their families from 6 European countries participated in the ToyBox-intervention and returned parental questionnaires in May/June 2012 and 2013. This study included the 3725 preschoolers/families who had complete data on water consumption, all mediators, and confounders. Mediation effects were assessed with bootstrapping procedure. RESULTS Regarding the intervention effects on family-related determinants, the ToyBox-intervention significantly increased water availability during meals, parental water consumption, parental encouragement to their children to drink water, and parental knowledge on water recommendations. In the multiple mediator model, all factors were independently associated with preschoolers' water consumption and mediated the intervention effect on preschoolers' water consumption (total mediation effect = 40%). After including all mediators into the model, the direct intervention effect remained significant. CONCLUSIONS The effect of the ToyBox-intervention on preschool children's water consumption was mediated by most family-related determinants examined in this study (ie, availability, parental modeling, parental encouragement, and parental knowledge). Interventions aiming to promote water in preschoolers should target these mediators to enhance their effectiveness.
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Adapting the ToyBox obesity prevention intervention for use in Scottish preschools: protocol for a feasibility cluster randomised controlled trial.
Malden, S, Hughes, AR, Gibson, AM, Bardid, F, Androutsos, O, De Craemer, M, Manios, Y, Summerbell, C, Cardon, G, Reilly, JJ
BMJ open. 2018;(10):e023707
Abstract
INTRODUCTION There is an increasing need for the adoption of effective preschool obesity prevention interventions to combat the high levels of early-childhood obesity in the UK. This study will examine the feasibility and acceptability of the adapted version of the ToyBox intervention-a preschool obesity prevention programme-for use in Scotland (ToyBox-Scotland). This will inform the design of a full-scale cluster randomised controlled trial (RCT). METHODS AND ANALYSIS The ToyBox-Scotland intervention will be evaluated using a feasibility cluster RCT, which involves children aged 3-5 years at six preschools in Glasgow, three randomly assigned to the intervention group and three to the usual-care control group. The original ToyBox intervention was adapted for the Scottish context using a coproduction approach. Within the 18-week intervention, physical activity and sedentary behaviour will be targeted in the preschool through environmental changes to the classroom, physical activity sessions and movement breaks. Parents will receive home activity packs every 3 weeks containing sticker incentives and interactive parent-child games that target sedentary behaviour, physical activity, eating/snacking and water consumption. As this is a feasibility study, parameters such as recruitment rates, attrition rates and SDs of outcome measures will be obtained which will inform a power calculation for a future RCT. Additional variables to be assessed include accelerometer-measured physical activity, sedentary behaviour and sleep, body mass index, home screen time, eating/snacking and water consumption. Outcomes will be assessed at baseline and 14-17 weeks later. Intervention fidelity will be assessed using questionnaires and interviews with parents and practitioners, observation and session delivery records. ETHICS AND DISSEMINATION This study was granted ethical approval by the University of Strathclyde's School of Psychological Sciences and Health Ethics Committee. Results will be disseminated through publication in peer-reviewed journals, presentation at conferences and in lay summaries provided to participants. TRIAL REGISTRATION NUMBER ISRCTN12831555.
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A school- and community-based intervention to promote healthy lifestyle and prevent type 2 diabetes in vulnerable families across Europe: design and implementation of the Feel4Diabetes-study.
Manios, Y, Androutsos, O, Lambrinou, CP, Cardon, G, Lindstrom, J, Annemans, L, Mateo-Gallego, R, de Sabata, MS, Iotova, V, Kivela, J, et al
Public health nutrition. 2018;(17):3281-3290
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OBJECTIVE To describe the design of the Feel4Diabetes-intervention and the baseline characteristics of the study sample. DESIGN School- 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. SETTING Primary schools and municipalities in six European countries. SUBJECTS Families (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). RESULTS The 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. CONCLUSIONS The 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.
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Characteristics of European adults who dropped out from the Food4Me Internet-based personalised nutrition intervention.
Livingstone, KM, Celis-Morales, C, Macready, AL, Fallaize, R, Forster, H, Woolhead, C, O'Donovan, CB, Marsaux, CF, Navas-Carretero, S, San-Cristobal, R, et al
Public health nutrition. 2017;(1):53-63
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OBJECTIVE To characterise participants who dropped out of the Food4Me Proof-of-Principle study. DESIGN The Food4Me study was an Internet-based, 6-month, four-arm, randomised controlled trial. The control group received generalised dietary and lifestyle recommendations, whereas participants randomised to three different levels of personalised nutrition (PN) received advice based on dietary, phenotypic and/or genotypic data, respectively (with either more or less frequent feedback). SETTING Seven recruitment sites: UK, Ireland, The Netherlands, Germany, Spain, Poland and Greece. SUBJECTS Adults aged 18-79 years (n 1607). RESULTS A total of 337 (21 %) participants dropped out during the intervention. At baseline, dropouts had higher BMI (0·5 kg/m2; P<0·001). Attrition did not differ significantly between individuals receiving generalised dietary guidelines (Control) and those randomised to PN. Participants were more likely to drop out (OR; 95 % CI) if they received more frequent feedback (1·81; 1·36, 2·41; P<0·001), were female (1·38; 1·06, 1·78; P=0·015), less than 45 years old (2·57; 1·95, 3·39; P<0·001) and obese (2·25; 1·47, 3·43; P<0·001). Attrition was more likely in participants who reported an interest in losing weight (1·53; 1·19, 1·97; P<0·001) or skipping meals (1·75; 1·16, 2·65; P=0·008), and less likely if participants claimed to eat healthily frequently (0·62; 0·45, 0·86; P=0·003). CONCLUSIONS Attrition did not differ between participants receiving generalised or PN advice but more frequent feedback was related to attrition for those randomised to PN interventions. Better strategies are required to minimise dropouts among younger and obese individuals participating in PN interventions and more frequent feedback may be an unnecessary burden.
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Profile of European adults interested in internet-based personalised nutrition: the Food4Me study.
Livingstone, KM, Celis-Morales, C, Navas-Carretero, S, San-Cristobal, R, O'Donovan, CB, Forster, H, Woolhead, C, Marsaux, CFM, Macready, AL, Fallaize, R, et al
European journal of nutrition. 2016;(2):759-769
Abstract
PURPOSE Personalised interventions may have greater potential for reducing the global burden of non-communicable diseases and for promoting better health and well-being across the lifespan than the conventional "one size fits all" approach. However, the characteristics of individuals interested in personalised nutrition (PN) are unclear. Therefore, the aim of this study was to describe the characteristics of European adults interested in taking part in an internet-based PN study. METHODS Individuals from seven European countries (UK, Ireland, Germany, The Netherlands, Spain, Greece and Poland) were invited to participate in the study via the Food4Me website ( http://www.food4me.org ). Two screening questionnaires were used to collect data on socio-demographic, anthropometric and health-related characteristics as well as dietary intakes. RESULTS A total of 5662 individuals expressed an interest in the study (mean age 40 ± 12.7; range 15-87 years). Of these, 65 % were female and 97 % were Caucasian. Overall, 13 % were smokers and 47 % reported the presence of a clinically diagnosed disease. Furthermore, 47 % were overweight or obese and 35 % were sedentary during leisure time. Assessment of dietary intakes showed that 54 % of individuals reported consuming at least 5 portions of fruit and vegetables per day, 46 % consumed more than 3 servings of wholegrains and 37 % limited their salt intake to <5.75 g per day. CONCLUSIONS Our data indicate that individuals volunteering to participate in an internet-based PN study are broadly representative of the European adult population, most of whom had adequate nutrient intakes but could benefit from improved dietary choices and greater physical activity. Future use of internet-based PN approaches is thus relevant to a wide target audience.
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Effect of an Internet-based, personalized nutrition randomized trial on dietary changes associated with the Mediterranean diet: the Food4Me Study.
Livingstone, KM, Celis-Morales, C, Navas-Carretero, S, San-Cristobal, R, Macready, AL, Fallaize, R, Forster, H, Woolhead, C, O'Donovan, CB, Marsaux, CF, et al
The American journal of clinical nutrition. 2016;(2):288-97
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BACKGROUND Little is known about the efficacy of personalized nutrition (PN) interventions for improving consumption of a Mediterranean diet (MedDiet). OBJECTIVE The objective was to evaluate the effect of a PN intervention on dietary changes associated with the MedDiet. DESIGN Participants (n = 1607) were recruited into a 6-mo, Internet-based, PN randomized controlled trial (Food4Me) designed to evaluate the effect of PN on dietary change. Participants were randomly assigned to receive conventional dietary advice [control; level 0 (L0)] or PN advice on the basis of current diet [level 1 (L1)], diet and phenotype [level 2 (L2)], or diet, phenotype, and genotype [level 3 (L3)]. Dietary intakes from food-frequency questionnaires at baseline and at 6 mo were converted to a MedDiet score. Linear regression compared participant characteristics between high (>5) and low (≤5) MedDiet scores. Differences in MedDiet scores between treatment arms at month 6 were evaluated by using contrast analyses. RESULTS At baseline, high MedDiet scorers had a 0.5 lower body mass index (in kg/m(2); P = 0.007) and a 0.03 higher physical activity level (P = 0.003) than did low scorers. MedDiet scores at month 6 were greater in individuals randomly assigned to receive PN (L1, L2, and L3) than in controls (PN compared with controls: 5.20 ± 0.05 and 5.48 ± 0.07, respectively; P = 0.002). There was no significant difference in MedDiet scores at month 6 between PN advice on the basis of L1 compared with L2 and L3. However, differences in MedDiet scores at month 6 were greater in L3 than in L2 (L3 compared with L2: 5.63 ± 0.10 and 5.38 ± 0.10, respectively; P = 0.029). CONCLUSIONS Higher MedDiet scores at baseline were associated with healthier lifestyles and lower adiposity. After the intervention, MedDiet scores were greater in individuals randomly assigned to receive PN than in controls, with the addition of DNA-based dietary advice resulting in the largest differences in MedDiet scores. Although differences were significant, their clinical relevance is modest. This trial was registered at clinicaltrials.gov as NCT01530139.
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A systematic approach for the development of a kindergarten-based intervention for the prevention of obesity in preschool age children: the ToyBox-study.
Manios, Y, Grammatikaki, E, Androutsos, O, Chinapaw, MJ, Gibson, EL, Buijs, G, Iotova, V, Socha, P, Annemans, L, Wildgruber, A, et al
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2012;:3-12
Abstract
The increasing childhood obesity epidemic calls for appropriate measures and effective policies to be applied early in life. Large-scale socioecological frameworks providing a holistic multifactorial and cost-effective approach necessary to support obesity prevention initiatives in this age are however currently missing. To address this missing link, ToyBox-study aims to build and evaluate a cost-effective kindergarten-based, family-involved intervention scheme to prevent obesity in early childhood, which could potentially be expanded on a pan-European scale. A multidisciplinary team of researchers from 10 countries have joined forces and will work to realize this according to a systematic stepwise approach that combines the use of the PRECEDE-PROCEED model and intervention mapping protocol. ToyBox-study will conduct systematic and narrative reviews, secondary data analyses, focus group research and societal assessment to design, implement and evaluate outcome, impact, process and cost effectiveness of the intervention. This is the first time that such a holistic approach has been used on a pan-European scale to promote healthy weight and healthy energy balance-related behaviours for the prevention of early childhood obesity. The results of ToyBox-study will be disseminated among key stakeholders including researchers, policy makers, practitioners and the general population.
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Design and implementation of the Healthy Lifestyle in Europe by Nutrition in Adolescence Cross-Sectional Study.
Moreno, LA, De Henauw, S, González-Gross, M, Kersting, M, Molnár, D, Gottrand, F, Barrios, L, Sjöström, M, Manios, Y, Gilbert, CC, et al
International journal of obesity (2005). 2008;:S4-11
Abstract
OBJECTIVE To provide an overview of the Healthy Lifestyle in Europe by Nutrition in Adolescence Cross-Sectional Study (HELENA-CSS) design, with particular attention to its quality control procedures. Other important methodological aspects are described in detail throughout this supplement. DESIGN Description of the HELENA-CSS sampling and recruitment approaches, standardization and harmonization processes, data collection and analysis strategies and quality control activities. RESULTS The HELENA-CSS is a multi-centre collaborative study conducted in European adolescents located in urban settings. The data management systems, quality assurance monitoring activities, standardized manuals of operating procedures and training and study management are addressed in this paper. Various quality controls to ensure collection of valid and reliable data will be discussed in this supplement, as well as quantitative estimates of measurement error. CONCLUSION The great advantage of the HELENA-CSS is the strict standardization of the fieldwork and the blood analyses, which precludes to a great extent the kind of immeasurable confounding bias that often interferes when comparing results from isolated studies.