NCT02375490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
897

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

2.8 years

First QC Date

February 24, 2015

Last Update Submit

November 30, 2017

Conditions

Keywords

ExerciseEating BehaviorPreschool ChildEarly Childcare CenterObesityPhysical Literacy

Outcome Measures

Primary Outcomes (3)

  • 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.

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

  • 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

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

  • 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.

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

Secondary Outcomes (1)

  • Early Childcare Center Practices and Policies for Physical Activity and Nutrition

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

Other Outcomes (2)

  • Body Mass Index

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

  • Waist circumference

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

Study Arms (2)

Intervention arm

EXPERIMENTAL

The intervention arm will participate in Healthy Start.

Behavioral: Healthy Start

Control arm

NO INTERVENTION

Control arm will pursue daily activities at early childcare center as usual.

Interventions

Healthy StartBEHAVIORAL

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.

Intervention arm

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Early childcare center must prepare and provide meals for lunch

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre de formation médicale du Nouveau-Brunswick

Moncton, New Brunswick, E1A 3E9, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7K 2L7, Canada

Location

Related Publications (57)

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  • Abobakar L, Engler-Stringer R, Leis A, Vatanparast H. Evaluation of the impact of the Healthy Start/Depart Sante intervention on improving menu planning practices and improving the congruence between planned menus and actual food served in Saskatchewan childcare centres. Prev Med Rep. 2021 May 25;23:101403. doi: 10.1016/j.pmedr.2021.101403. eCollection 2021 Sep.

  • Ward S, Belanger M, Leis A. Comparison between the Healthy Start-Depart Sante online and in-person training of childcare educators to improve healthy eating and physical activity practices and knowledge of physical activity and fundamental movement skills: A controlled trial. Prev Med Rep. 2020 Nov 28;20:101264. doi: 10.1016/j.pmedr.2020.101264. eCollection 2020 Dec.

  • Leis A, Ward S, Vatanparast H, Humbert ML, Chow AF, Muhajarine N, Engler-Stringer R, Belanger M. Effectiveness of the Healthy Start-Depart Sante approach on physical activity, healthy eating and fundamental movement skills of preschoolers attending childcare centres: a randomized controlled trial. BMC Public Health. 2020 Apr 19;20(1):523. doi: 10.1186/s12889-020-08621-9.

  • Belanger M, Humbert L, Vatanparast H, Ward S, Muhajarine N, Chow AF, Engler-Stringer R, Donovan D, Carrier N, Leis A. A multilevel intervention to increase physical activity and improve healthy eating and physical literacy among young children (ages 3-5) attending early childcare centres: the Healthy Start-Depart Sante cluster randomised controlled trial study protocol. BMC Public Health. 2016 Apr 12;16:313. doi: 10.1186/s12889-016-2973-5.

MeSH Terms

Conditions

Pediatric ObesityMotor ActivityFeeding BehaviorObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBehavior, Animal

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 2, 2015

Study Start

September 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 2, 2017

Record last verified: 2017-11

Locations