Healthy Start to Increase Physical Activity and Improve Healthy Eating in Early Childcare Centres
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02375490|
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : December 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Obesity||Behavioral: Healthy Start||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||897 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: Intervention arm
The intervention arm will participate in Healthy Start.
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.
No Intervention: Control arm
Control arm will pursue daily activities at early childcare center as usual.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375490
|Canada, New Brunswick|
|Centre de formation médicale du Nouveau-Brunswick|
|Moncton, New Brunswick, Canada, E1A 3E9|
|University of Saskatchewan|
|Saskatoon, Saskatchewan, Canada, S7K 2L7|
|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|