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Pediatric ObesityNCT02375490

Healthy Start to Increase Physical Activity and Improve Healthy Eating in Early Childcare Centres

A study testing Healthy Start in people with Pediatric Obesity, run by Université de Sherbrooke at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 3 to 5 yearsHealthy volunteers can take part
Conditions the study is for
Pediatric Obesity
What is being tested?
Healthy Start
Could I receive a placebo?
No, everyone receives an active treatment
How many people
897 participants
Where
2 sitesCanada
Study dates
Sep 2013to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Early childcare center must prepare and provide meals for lunch

Who cannot join

  • Any early childcare center that has already received a physical activity or nutrition promoting intervention in the past to avoid underestimating the effect of the Healthy Start intervention
  • For feasibility reasons, the number of children attending the early childcare center also serves as an exclusion criterion; centers with less than 20 children from the ages of 3 to 5 are not considered

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Centre de formation médicale du Nouveau-Brunswick

    Moncton, New Brunswick, E1A 3E9

  • University of Saskatchewan

    Saskatoon, Saskatchewan, S7K 2L7

Other trials in Canada

About this study

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.

Read the detailed description

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.
Being tested
Healthy Start
Keywords
Exercise, Eating Behavior, Preschool Child, Early Childcare Center, Obesity, Physical Literacy
Medical subject headings
Pediatric Obesity, Motor Activity, Feeding Behavior, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy StartBehavioural

    Healthy Start was designed to promote physical activity and healthy eating among 3-5 year old children. Specifically, Healthy Start attempts to influence factors at the intrapersonal, interpersonal, organizational, community and physical environment and political levels. These levels of influence are targeted such that from an operational stand point, Healthy Start is composed of six interlinked components: 1) intersectoral partnerships that leads to promoting healthy weights in communities and ECC; 2) The Healthy Start guide for educators; 3) customized training, role modelling and monitoring; 4) an evidence-based resource for both families and educators; 5) supplementary resources from governmental partners; and 6) a knowledge development and exchange, and communication strategy.

Study groups in NCT02375490
Study groupRoleWhat they receive
Intervention armExperimentalThe intervention arm will participate in Healthy Start.
Receives: Behavioral: Healthy Start
Control armNo interventionControl arm will pursue daily activities at early childcare center as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Activity Level

    Children's physical activity levels are obtained using an Actical accelerometer worn during attendance of ECC for five consecutive days. Accelerometers represent an objective and valid method of measuring physical activity in preschool aged children.

    Measured: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.

  2. Physical Literacy

    Physical literacy and gross motor skills of children will be measured using the Test of Gross Motor Development (TGMD-II). The TGMD-II is a standardized test designed to assess the gross motor functioning in children aged 3 through 10 years

    Measured: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.

  3. Dietary Intake

    Intake analysis provides information on the intake of calories, macronutrients and micronutrients in children attending the centers. This method has been extensively used in studies concerning school-aged children and is considered the most precise measurement of dietary intake. In this study, intake analysis is done using the photography-assisted weighted plate waste method centers.

    Measured: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.

Secondary outcomes (1)
  1. Early Childcare Center Practices and Policies for Physical Activity and Nutrition

    Dietary and physical activity practices and policies in ECC are measured using the Nutrition and Physical Activity Self-Assessment of Child Care (NAP SACC), filled out independently by two research assistants in each ECC.

    Measured: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2015 (estimated)
  2. Study startSep 2013
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
897 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02375490
Sponsor's protocol ID
6282-15-2010/3381056-RSFS
Status last verified
Nov 2017
First submitted
24 Feb 2015
Last updated
2 Dec 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • de Onis M, Blossner M, Borghi E. Global prevalence and trends of overweight and obesity among preschool children. Am J Clin Nutr. 2010 Nov;92(5):1257-64. doi: 10.3945/ajcn.2010.29786. Epub 2010 Sep 22.

    PubMed 20861173
  • Shields M. Overweight and obesity among children and youth. Health Rep. 2006 Aug;17(3):27-42.

    PubMed 16981484
  • Reilly JJ, Methven E, McDowell ZC, Hacking B, Alexander D, Stewart L, Kelnar CJ. Health consequences of obesity. Arch Dis Child. 2003 Sep;88(9):748-52. doi: 10.1136/adc.88.9.748.

    PubMed 12937090
  • Gardner DS, Hosking J, Metcalf BS, Jeffery AN, Voss LD, Wilkin TJ. Contribution of early weight gain to childhood overweight and metabolic health: a longitudinal study (EarlyBird 36). Pediatrics. 2009 Jan;123(1):e67-73. doi: 10.1542/peds.2008-1292.

    PubMed 19117849
  • Nader PR, O'Brien M, Houts R, Bradley R, Belsky J, Crosnoe R, Friedman S, Mei Z, Susman EJ; National Institute of Child Health and Human Development Early Child Care Research Network. Identifying risk for obesity in early childhood. Pediatrics. 2006 Sep;118(3):e594-601. doi: 10.1542/peds.2005-2801.

    PubMed 16950951
  • Quattrin T, Liu E, Shaw N, Shine B, Chiang E. Obese children who are referred to the pediatric endocrinologist: characteristics and outcome. Pediatrics. 2005 Feb;115(2):348-51. doi: 10.1542/peds.2004-1452.

    PubMed 15687443
  • Guo SS, Huang C, Maynard LM, Demerath E, Towne B, Chumlea WC, Siervogel RM. Body mass index during childhood, adolescence and young adulthood in relation to adult overweight and adiposity: the Fels Longitudinal Study. Int J Obes Relat Metab Disord. 2000 Dec;24(12):1628-35. doi: 10.1038/sj.ijo.0801461.

    PubMed 11126216
  • Freedman DS, Khan LK, Serdula MK, Dietz WH, Srinivasan SR, Berenson GS. The relation of childhood BMI to adult adiposity: the Bogalusa Heart Study. Pediatrics. 2005 Jan;115(1):22-7. doi: 10.1542/peds.2004-0220.

    PubMed 15629977
  • Hill JO, Melanson EL. Overview of the determinants of overweight and obesity: current evidence and research issues. Med Sci Sports Exerc. 1999 Nov;31(11 Suppl):S515-21. doi: 10.1097/00005768-199911001-00005.

    PubMed 10593521
  • Birch LL, Fisher JO. Development of eating behaviors among children and adolescents. Pediatrics. 1998 Mar;101(3 Pt 2):539-49.

    PubMed 12224660
  • Pabayo R, Spence JC, Casey L, Storey K. Food consumption patterns in preschool children. Can J Diet Pract Res. 2012 Summer;73(2):66-71. doi: 10.3148/73.2.2012.66.

    PubMed 22668839
  • Reedy J, Krebs-Smith SM. Dietary sources of energy, solid fats, and added sugars among children and adolescents in the United States. J Am Diet Assoc. 2010 Oct;110(10):1477-84. doi: 10.1016/j.jada.2010.07.010.

    PubMed 20869486
  • Langlois K, Garriguet D. Sugar consumption among Canadians of all ages. Health Rep. 2011 Sep;22(3):23-7.

    PubMed 22106786
  • Reilly JJ, Kelly J. Long-term impact of overweight and obesity in childhood and adolescence on morbidity and premature mortality in adulthood: systematic review. Int J Obes (Lond). 2011 Jul;35(7):891-8. doi: 10.1038/ijo.2010.222. Epub 2010 Oct 26.

    PubMed 20975725
  • Temple VA, Naylor PJ, Rhodes RE, Higgins JW. Physical activity of children in family child care. Appl Physiol Nutr Metab. 2009 Aug;34(4):794-8. doi: 10.1139/H09-061.

    PubMed 19767816

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Start in people with Pediatric Obesity, run by Université de Sherbrooke at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Activity Level (time frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02375490, which also lists 57 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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