Pediatric Obesity Clinical Trial
Official title:
A Multilevel Intervention to Increase Physical Activity and Improve Healthy Eating Among Young Children (Ages 3-5) Attending Early Childcare Centres: the Healthy Start Study
Childhood obesity is one of the greatest challenges facing public health and recent evidence shows it begins in preschool aged children. It has been suggested that interventions be carried out to improve physical activity and healthy eating behaviour among young children. This study aims to fully evaluate Healthy Start, a multilevel physical activity and healthy eating intervention for preschool aged children. It is hypothesized that the Healthy Start intervention will improve both eating and physical activity behaviors of children attending early childcare centers because of its influence on multiple factors.
Childhood obesity is one of the greatest challenges facing public health in the 21st century.
In 2010, an estimated 43 million preschool aged children suffered from overweight or obesity
and another 92 million were at risk of being overweight. From 1990 to 2010, the prevalence of
overweight and obesity in children under the age of 5 increased from 4.2% to 6.7%, and it is
estimated that 60 million children will suffer from being overweight by 2020. In Canada, the
prevalence of obesity in preschool aged children is three times higher than the global
average. Being overweight in childhood has been associated with compromised emotional health
and social wellbeing. Much of the excess weight in obese children is gained before the age of
5 years and many studies indicate that adiposity tracks into childhood. Further, children who
become obese before the age of 6 are at least four times more at risk of obesity in
adulthood.
The problem of obesity is multifactorial, but is primarily influenced by energy intake and
energy expenditure. Eating habits are established early in childhood and can be sustained for
many years. Data show that only 29% of Canadian preschool aged children meet recommendations
for fruit and vegetable intake and 23% for grain products. Further, 79% of 4-5 year olds
consume food of little nutritional value (ex: chips, french fries, candy, chocolate, soft
drinks, cake and cookies) at least once a week and other studies have demonstrated that empty
calories are making up as much as 40% of their total caloric intake. Similarly, a recent
review demonstrated that physical activity (PA) levels in early childcare centers (ECC) are
generally low, and that time spent in sedentary state is elevated. It was estimated that
children in ECC accumulate an average of 7 to 13 minutes of moderate-to-vigorous PA (MVPA)
during the course of a 7 hour day. Correspondingly, recent data suggest that the prevalence
of children with poor physical literacy is high and that low physical literacy competence is
negatively associated with PA, cardiorespiratory fitness and weight status. These data are
troubling given that sedentary and physical activity levels track over time.
Several organizations have recognized the need to counter pediatric obesity and to develop
physical activity and nutrition-based interventions for pre-school populations. More than
half of young Canadians between the ages of 6 months and 5 years spend around 29 hours a week
in ECC, making them rich environments for implementing strategies to help children adopt
healthy lifestyles. For example, one pilot study demonstrated an increase in fruit and
vegetable intake following nutrition education and increased availability of healthy foods in
ECC. Another intervention study integrating physical activity in all aspects of the preschool
curriculum reported a 2 minute increase in classroom MVPA as assessed by accelerometer.
However, both a systematic review on obesity prevention interventions in children under 5
years and another on obesity prevention policies, practice and interventions in ECC reported
limited success of current interventions in positively influencing physical activity levels,
dietary behaviour, or body composition. The authors suggest that the least successful
interventions were unidimensional, while the most successful interventions were those with a
positive impact on knowledge, abilities and competence, suggesting that interventions should
be conceived based on comprehensive behaviour change models. It was also found that few
interventions focused on physical activity and eating behaviour in combination, and that
future interventions should target both behaviours simultaneously.
Interventions promoting healthy weight in children should encompass a broad spectrum of
concerted actions and be based on best available knowledge from research and practice.
Healthy Start, an intersectional multilevel physical activity and healthy eating promotion in
preschool aged children, was developed on these bases. The aim of the current study is to
lead a comprehensive evaluation of the Healthy Start intervention using an experimental
research design.
The Intervention The population health approach is based on the concept that in order to
positively influence population-level health outcomes, one needs to account for the wide
range of health determinants [39], recognise the importance and complexity of potential
interplay among these determinants, and reduce social and material inequities. Further,
interventions adhering to principles of the population health approach rely on best evidence
available, stimulate intersectoral collaborations, and provide opportunities for all
potential stakeholders to be meaningfully engaged in its development. Several models based on
the population health approach have been developed to help guide interventions. These models
provide holistic conceptual frameworks which, similar to ecological models, suggest that
interventions include a series of concerted actions capable of targeting all levels of
influence, including the intrapersonal (biological and psychological), interpersonal (social
and cultural), organizational, community, physical environment and political levels.
The conceptual development of Healthy Start is based on this population health approach; it
includes strategies to guide each level of influence with the aim of improving children
physical activity and dietary behaviours. The development of Healthy Start was a concerted
action including academicians, community groups, educators, parents, and government
representatives. Their effort, supported by Phase I of federal funding from the Public Health
Agency of Canada (2007-2010), also involved pilot testing and improving the intervention
which was designed to be multilevel, inclusive, intersectoral. It is also noteworthy, that
Healthy Start was developed to be linguistically and culturally adapted to cater to both
official linguistic groups in Canada, which is important since it has been documented that to
be effective, it is not sufficient for interventions to be translated, they must also have
been adapted for the target population.
Therefore, Healthy Start was designed to promote physical activity and healthy eating among
Anglophone and Francophone 3-5 year old children in ECC (i.e. licenced daycares, preschools
and pre-kindergarten programs). The vision of Healthy Start is to ensure young children eat
healthily and are physically active every day. The mission is to encourage and enable
families and educators to integrate physical activity and healthy eating in the daily lives
of young children. Specifically, Healthy Start attempts to influence factors at the
intrapersonal (ex: eating and physical activity behaviour of children), interpersonal (ex:
educators and parents), organizational (ex. child care centres), community (ex: community
organization involvement), and physical environment and political levels (ex: built
environment and policies). These levels of influence are targeted such that from an
operational stand point, Healthy Start is composed of six interlinked components (more
details presented in Figure 1) : 1) intersectoral partnerships conducive to participatory
action that leads to promoting healthy weights in communities and ECC; 2) The Healthy Start
guide for educators on implementing healthy eating and physical activity in young children;
3) customized training, role modelling and monitoring of Healthy Start in early learning
centres; 4) an evidence-based resource, LEAP-GRANDIR which contains material for both
families and educators; 5) supplementary resources from governmental partners; and 6) a
knowledge development and exchange (KDE), and communication strategy involving social media
and web-resources to raise awareness and mobilize grassroots organizations and communities.
Study Objectives
It is hypothesized that, in comparison to usual practice, exposure to the Healthy Start
intervention will lead to improved opportunities for physical activities and healthy eating
and to increased physical activity and healthier eating among children. The specific study
objectives are to:
1. Investigate whether the Healthy Start intervention leads to increases in child care
centre-provided opportunities for physical activity and healthy eating;
2. Investigate whether the Healthy Start intervention leads to increases in physical
activity levels and healthy eating behaviours among children; and
3. Investigate whether the Healthy Start intervention leads to improvements in physical
literacy among children.
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