Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
University of Saskatchewan
Information provided by (Responsible Party):
Mathieu Bélanger, Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: Healthy Start Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 897 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, New Brunswick
Centre de formation médicale du Nouveau-Brunswick
Moncton, New Brunswick, Canada, E1A 3E9
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7K 2L7
Sponsors and Collaborators
Université de Sherbrooke
University of Saskatchewan
Investigators
Layout table for investigator information
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
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mathieu Bélanger, Associate professor, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02375490    
Other Study ID Numbers: 6282-15-2010/3381056-RSFS
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mathieu Bélanger, Université de Sherbrooke:
Exercise
Eating Behavior
Preschool Child
Early Childcare Center
Obesity
Physical Literacy
Additional relevant MeSH terms:
Layout table for MeSH terms
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight