Preschoolers Activity Trial

NCT02293278 | Completed

• 1 other identifier: 10/85X
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to test the efficacy of the physical activity (PA) intervention protocol to increase preschoolers overall PA levels and time spent in moderate to vigorous PA (MVPA) at the day care setting. The PA intervention includes the Healthy Opportunities for Preschoolers manual, a compilation of locomotor, gross motor and movement based activities developed for preschoolers and successfully piloted for feasibility in 3 to 5 year old preschoolers by Drs. Viviene Temple, Justen O'Connor, and Patti-Jean Naylor. As well, the PA intervention includes educational workshops for the day care providers, ongoing biweekly facilitation and troubleshooting sessions with a Master Trainer, and the equipment necessary to implement the program. The study is also evaluating the efficacy of the PA intervention to decrease the amount of time spent in sedentary behaviour at the day care setting. Secondary objectives include evaluating the effects of the PA intervention on preschool children's anthropometrics, and fundamental and gross motor skills. In addition, the intervention is also assessing the effects of the program on day care provider's attitudes, control beliefs, and self-efficacy toward incorporating PA into the day care curriculum.

Conditions

Obesity

Keywords

MVPA; sedentary behaviour; PA intervention; preschool; gross motor; anthropometrics; day care

Outcome Measures

Primary Outcomes (1)

• Increase MVPA

  Moderate to vigorous physical activity (MVPA) is measured objectively with the children wearing Actical accelerometers for one week. MVPA measured in minutes per day.

  6 months

Secondary Outcomes (5)

• Effect of PA intervention on anthropometrics of preschoolers.

  6 months

• Effect of PA intervention on fundamental and gross motor skills of preschoolers.

  6 months

• Effects of PA intervention on day care provider's attitudes, control beliefs and self efficacy.

  6 months

• Decrease sedentary behaviour

  6 months

• Increase Total Physical Activity

  6 months

Study Arms (2)

Physical Activity Intervention

EXPERIMENTAL

The intervention consists of 2, 3-hour workshops conducted by a master trainer with experience in promoting PA in preschoolers. Each provider in the intervention group is given the Healthy Opportunities for Preschoolers resource training manual, suggested implementation, and a starter kit of equipment. Master Trainers facilitated biweekly PA sessions throughout the intervention. During the 6 month intervention, Preschoolers Activity Trial staff will visit the day care facilities to conduct baseline, 3 month, and 6 month measurements.

Behavioral: Physical Activity Intervention

Control Group

NO INTERVENTION

Day cares randomly assigned to the control group will continue with their existing programming. Day care providers will receive the PA intervention upon completion of their involvement in the 6 month trial, including: 2 three hour educational workshops, Healthy Opportunities for Preschoolers manual and program outlining the ideal implementation of activities from the manual. During the 6 month intervention, Preschoolers Activity Trial staff will visit the day care facilities to conduct baseline, 3 month, and 6 month measurements.

Interventions

Physical Activity Intervention BEHAVIORAL

The intervention consists of 2, 3-hour workshops conducted by a master trainer with experience in promoting PA in preschoolers. The workshops focus on the importance of PA and movement skills for preschool-aged children, understanding structured and unstructured play, practical activities related to movement skills, how to overcome barriers in facilitating PA, and using everyday materials to facilitate PA and active play. Each provider in the intervention group is given the Healthy Opportunities for Preschoolers resource training manual, suggested implementation, and a starter kit of equipment. Master Trainers facilitated biweekly PA sessions throughout the intervention. The intervention is based on NASPE (2002) guidelines of not having children sedentary more than 60 mins at a time, having children accumulate 60 mins in structured and unstructured PA (active play) each day at MVPA, as well as 180 mins of total PA as recommended by the Canadian PA Guidelines for preschoolers.

Physical Activity Intervention

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or Female
• to 5 years old
• Enrolled full-time at a participating, licensed daycare/child care facility

You may not qualify if:

• Activity restrictions due to disease: unstable cardiac or pulmonary disease, significant arthritis
• Other illness judged by the parent/guardian to make participation in this study inadvisable
• Significant cognitive deficit resulting in inability to understand or comply with instructions
• Inability to communicate in English or French
• Unwillingness of parent/guardian to sign informed consent

Sponsors & Collaborators

• Healthy Active Living and Obesity Research Group: lead
• University of Victoria: collaborator
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario Research Institute

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (1)

• Goldfield GS, Harvey ALJ, Grattan KP, Temple V, Naylor PJ, Alberga AS, Ferraro ZM, Wilson S, Cameron JD, Barrowman N, Adamo KB. Effects of Child Care Intervention on Physical Activity and Body Composition. Am J Prev Med. 2016 Aug;51(2):225-231. doi: 10.1016/j.amepre.2016.03.024. Epub 2016 May 11.

  PMID: 27180030 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gary S Goldfield, PhD

  HALO, CHEO RI

  PRINCIPAL INVESTIGATOR

• Kristi B Adamo, PhD

  HALO, CHEO RI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: November 18, 2014
• Study Start: February 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

CA (1)