KEIGAAF: Kansen in Eindhoven voor een GezinsAAnpak met Fontys|
|- candidate number||27462|
|- NTR Number||NTR6716|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-jun-2017|
|- Secondary IDs||NL58554.068.16 METC azM/UM|
|- Public Title||KEIGAAF: Kansen in Eindhoven voor een GezinsAAnpak met Fontys|
|- Scientific Title||The implementation and evaluation of KEIGAAF, a combined school- and home-based physical activity and nutrition intervention for primary school-aged children living in low socioeconomic neighborhoods of Eindhoven.|
|- hypothesis||There are inequalities in health and energy balance-related behaviors among high and low socioeconomic groups. Differences in health behaviors between different socioeconomic groups are already visible at a young age. Also in the Dutch municipality Eindhoven, inequalities in health and energy balance-related behaviors among children from different socioeconomic groups are present. Multiple setting interventions, having a school-centered approach with a family-based component, are likely to be effective on children’s energy balance-related behaviors. A combined school- and family-based intervention aimed at improving energy balance-related behaviors, i.e. physical activity, sedentary behavior and nutrition behavior, of children in grade 4 to 6 will be implemented and evaluated.|
The objective of the study is to determine the effect of KEIGAAF on the Body Mass Index adjusted for age and gender (BMI z-score) and waist circumference of children in grade 4 to 6, living in low socioeconomic neighborhoods in Eindhoven, after one year and two years of intervention. It is hypothesized that an increase in the BMI z-score of children participating in the KEIGAAF intervention will be significantly prevented compared to children in the control condition. Secondarily, the effect of KEIGAAF on physical activity behavior, physical fitness, sedentary behavior and nutrition behavior at school, after one and two years, will be investigated. n addition, a process evaluation will be conducted to study the implementation of KEIGAAF and explain intervention results.
|- Healt Condition(s) or Problem(s) studied||Physical activity, BMI, Ingestive behaviour, Low socio-economical status (SES)|
|- Inclusion criteria||There are some eligibility criteria for the schools to participate in the study: 1)schools are located in a low socio-economic neighborhood; 2) they have no plans to merge with another school or plans to relocate during the intervention period ; 3) the school staff is willing to actively participate in KEIGAAF and work together with parents and local partners, e.g. sports professionals, social workers and/or municipality officers. All children in grade 4 to 6, of which the parents consented with participation, are eligible to participate in the study.
|- Exclusion criteria||Participants will be excluded from the analysis when they have a physical disability that hampers the execution of physical activity or the physical fitness test at the time of measurement (e.g. a broken leg). No other exclusion criteria are applicable.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-mrt-2017|
|- planned closingdate||30-jun-2019|
|- Target number of participants||523|
|- Interventions||The intervention consists of a combined top-down and bottom-up approach. Each KEIGAAF school forms a KEIGAAF team in which school members, e.g. teachers, the PE teacher and/or the school principal, parents, local professionals, like sports professionals, social workers and health promotors, work together to create an environment that stimulates children to be physically active and eat healthily. These teams are supported by a researcher of Maastricht University or Fontys University of Applied Sports Science. Dependent on the local needs and possibilities the KEIGAAF teams will develop and implement so-called KEIGAAF activities: activities that aim to transform the physical and social environment (e.g. stimulating active transportation to school, changing the schoolyard, promoting healthy school lunch). These activities can be new activities and activities that enhance already existing school health promoting activities. The school is seen as the center of the neighborhood. Activities will thus be initiated from within the school with the intention to spread out into the community. To support the KEIGAAF teams in developing the context-specific KEIGAAF intervention, research results will be shared with the teams. The school and neighborhood environment will be observed with the SPACE checklist (de Vries, Hopman-Rock, Bakker, Hirasing, & van Mechelen, 2010) to give insight into the environmental barriers and facilitators of physical activity of the children. With a school scan the current school’s policies and activities stimulating the energy balance-related behaviors of the students are identified. Additionally, the KEIGAAF teams are provided examples of effective activities that can be implemented. |
In addition to the school-based intervention, a family intervention is implemented primarily aimed at parents of which the children are already overweight. The KEIGAAF family intervention is a program in which parents are coached on lifestyle related parenting practices by a lifestyle coach. Parents are recruited at the KEIGAAF schools. With the results of the baseline measurements on children’s BMI z-score and waist circumference, the child and its’ parents are selected for the KEIGAAF family intervention. Parents attend 10 parent-focused group sessions of approximately 90 to 120 minutes. Besides, parents receive 4 home (or telephone) sessions. One or (preferably) both parents attend the sessions. In groups of 6 to 12 persons the parents are coached on positive parenting, lifestyle-related parenting practices and creating a healthy home environment. Parallel to the parent group sessions, the children participate in fun active group play sessions led by a sports professional.
The control schools will only be subjected to the measurements at T0, T1 and T2.
|- Primary outcome||The main study parameters are children’s body composition, determined by BMI z-score (calculated by weight and height and adjusted for the age and gender of the child) and waist circumference.|
|- Secondary outcome||The secondary study parameters are children’s physical activity behavior and sedentary behavior, physical activity on a normal school day (before, during and after school), nutrition behavior at school (snack intake, water and soft drink consumption, fruit and vegetable consumption), physical fitness, transportation to school, sports participation, physical activity enjoyment, physical activity preferences and food preferences. Socio-demographic variables like age, ethnicity, family composition are also assessed.|
To see if the intervention in the school-centered setting also affects the home-environment of the child the following outcomes concerning the home environment are assessed: parental activity transportation routines, parental support to be active and the family health climate. Besides, parents’ self-reported height and weight will be assessed (to calculate BMI) and socio-demographic variables like age, relation to the child, ethnicity, education level and hours of employment are assessed.
Data regarding the implementation of KEIGAAF and the implemented activities are collected.
|- Timepoints||Measurements are taken at baseline (T0), after one year (T1) and after two years (T2). Process data on the implementation of the KEIGAAF intervention is collected throughout the study.|
|- Trial web site||www.keigaafeindhoven.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. D.H.H. Kann, Van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. D.H.H. Kann, Van|
|- Sponsor/Initiator ||Maastricht University|
(Source(s) of Monetary or Material Support)
|- Brief summary||RATIONALE: Multiple setting interventions, having a school-centered approach with a family-based component, are likely to prevent overweight and improve energy balance-related behaviors of children. A combined school- and family-based physical activity and nutrition intervention will be developed and implemented in schools located in low socioeconomic neighborhoods in Eindhoven. The aim of the intervention is to increase active living and promote healthy eating among primary school-aged children. The intervention is called KEIGAAF (a Dutch acronym for 'Chances in Eindhoven for a family-based intervention with Fontys’).|
OBJECTIVE: The aim of the KEIGAAF intervention is to primarily prevent an increase in body mass index adjusted for age and gender (BMI z-score) and waist circumference. Secondarily, the intervention aims to increase physical activity levels, decrease sedentariness, improve nutrition behavior at school and increase the physical fitness children in grade 4 to 6 after two years of intervention. The effectiveness of the intervention on these outcome measures will be studied. In addition, a process evaluation will be conducted to explain intervention effectiveness.
STUDY DESIGN: The study has a quasi-experimental design with a comparison group. Control schools are located in another municipality and are comparable to the intervention schools in terms of neighborhood socioeconomic status. Measurements will be collected before the implementation of the intervention (T0), after one year (T1, short-term follow-up) and after two years (T2, long-term follow-up).
STUDY POPULATION: Children in grade 4 to 6 of primary school are included in the study. The KEIGAAF family intervention is particularly aimed at families with one or more overweight children of the intervention schools.
INTERVENTION: In schoolyear 2016-2017, each KEIGAAF school will form a KEIGAAF team which is responsible for creating an environment that stimulates physical activity and healthy eating among the children. The teams consist of teachers, PE teacher, school principal, parents and local professionals, like sports professionals, social workers and health promoters. The teams are supported by a researcher, which is a familiar with evidence-based health promoting interventions and who provides guidelines to the teams for a succesfull developmend and implementation of KEIGAAF. The teams are responsible for the development and implementation of so-called KEIGAAF activities: activities that stimulate children to be physically active and eat more healthily. The KEIGAAF intervention is in accordance with the local needs and thus context-specific. KEIGAAF activities will be implemented after the baseline measurements have been conducted in March and April 2017. The aim is that KEIGAAF becomes embedded in the local structures of the school and neighborhood. The KEIGAAF family intervention targets the children already overweight and their parents and aims to improve lifestyle parenting practices and the home environment. The family lifestyle program consists of parent group sessions and family home visits and will be implemented in schoolyear 2017-2018.
OUTCOME MEASURES: The main study outcomes are children’s body composition, determined by BMI z-score and waist circumference. Secondary outcome measurements are children physical activity behavior, sedentary behavior, nutrition behavior at school and physical fitness. Children will be measured and weighed, they will fill in a questionnaire and conduct a physical fitness test. The children will wear a accelerometer for seven consecutive days. Parents will also be requested to fill in a questionnaire. Process data will be collected throughout the study.
EXPECTED BENEFITS: The intervention is expected to result in a healthier lifestyle of the child and better parental skills of the participating parents in the family intervention. The intervention aims to prevent an increase in BMI z-score, thus, reducing related health risks. The measurements of this study are non-invasive. There are no risks involved in the measurements of this study.
|- Main changes (audit trail)|
|- RECORD||27-jun-2017 - 7-okt-2017|
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