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

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ClinicalTrials.gov Identifier: NCT02375490
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : December 2, 2017
Sponsor:
Collaborator:
University of Saskatchewan
Information provided by (Responsible Party):
Mathieu Bélanger, Université de Sherbrooke

Tracking Information
First Submitted Date  ICMJE February 24, 2015
First Posted Date  ICMJE March 2, 2015
Last Update Posted Date December 2, 2017
Study Start Date  ICMJE September 2013
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • Physical Activity Level [ Time Frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention. ]
    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.
  • Physical Literacy [ Time Frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention. ]
    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
  • Dietary Intake [ Time Frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention. ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
Early Childcare Center Practices and Policies for Physical Activity and Nutrition [ Time Frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention. ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • Body Composition [ Time Frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention. ]
    Height, weight and waist circumference are measured using a standardized protocol. Body mass index (BMI), calculated using the ratio of weight (kg) and squared height (m2) will be used to determine if children are overweight or obese by following the International Obesity Task Force thresholds as recommended.
  • Early Childcare Center Practices and Policies for Physical Activity and Nutrition [ Time Frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention. ]
    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.
Current Other Pre-specified Outcome Measures
 (submitted: March 2, 2015)
  • Body Mass Index [ Time Frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention. ]
    Height and weight are measured using a standardized protocol. A composite outcome measure, body mass index (BMI), is calculated using the ratio of weight (kg) and squared height (m2) and will be used to determine if children are overweight or obese by following the International Obesity Task Force thresholds as recommended.
  • Waist circumference [ Time Frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention. ]
    Waist circumference is measured using a standardized protocol. Two measures of waist circumference to the nearest 0.1cm are obtain for each participant. If discrepancies greater than 0.5 cm are observed between the two measures, a third measure is obtained. The average of the two closest measures is recorded.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Start to Increase Physical Activity and Improve Healthy Eating in Early Childcare Centres
Official Title  ICMJE 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
Brief 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. 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pediatric Obesity
Intervention  ICMJE Behavioral: Healthy Start
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 Arms  ICMJE
  • Experimental: Intervention arm
    The intervention arm will participate in Healthy Start.
    Intervention: Behavioral: Healthy Start
  • No Intervention: Control arm
    Control arm will pursue daily activities at early childcare center as usual.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2017)
897
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2015)
735
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Early childcare center must prepare and provide meals for lunch

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02375490
Other Study ID Numbers  ICMJE 6282-15-2010/3381056-RSFS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mathieu Bélanger, Université de Sherbrooke
Study Sponsor  ICMJE Université de Sherbrooke
Collaborators  ICMJE University of Saskatchewan
Investigators  ICMJE
Principal Investigator: Anne Leis, PhD University of Saskatchewan
Principal Investigator: Mathieu Bélanger, PhD Université de Sherbrooke
Principal Investigator: Louise Humbert, PhD University of Saskatchewan
Principal Investigator: Hassan Vatanparast, PhD University of Saskatchewan
Principal Investigator: Nazeem Muhajarine, PhD University of Saskatchewan
PRS Account Université de Sherbrooke
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP