NCT03668678

Brief Summary

The objective of this study was to determine the efficacy of the iGrow Readers curriculum in changing diet and physical activity knowledge among preschool-aged children. The secondary objective of this study was to better understand the relationship between diet and physical activity related outcome variables in preschool aged children and their primary caregivers.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
568

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

September 7, 2018

Last Update Submit

January 15, 2019

Conditions

Keywords

ObesityPhysical ActivityNutritionCurriculumPreschoolLiteracy

Outcome Measures

Primary Outcomes (1)

  • Change in Nutrition and Physical Activity Knowledge

    The Child Nutrition and Physical Activity Survey Tool was used for assessment of nutrition and physical activity knowledge in children.

    Data was collected prior to delivering the curriculum (pre-intervention), from 6-13 weeks after the intervention (post-intervention), and 24-33 weeks following the completion of the intervention (follow-up).

Secondary Outcomes (11)

  • Change in Height

    Data was collected prior to delivering the curriculum (pre-intervention), from 6-13 weeks after the intervention (post-intervention), and 24-33 weeks following the completion of the intervention (follow-up)

  • Change in Weight

    Data was collected prior to delivering the curriculum (pre-intervention), from 6-13 weeks after the intervention (post-intervention), and 24-33 weeks following the completion of the intervention (follow-up)

  • Change in Body Composition - Lean mass and fat mass

    Data was collected prior to delivering the curriculum (pre-intervention), from 6-13 weeks after the intervention (post-intervention), and 24-33 weeks following the completion of the intervention (follow-up)

  • Change in Body Mass Index

    Data was collected prior to delivering the curriculum (pre-intervention), from 6-13 weeks after the intervention (post-intervention), and 24-33 weeks following the completion of the intervention (follow-up)

  • Teacher Perceptions of the Curriculum

    up to 33 weeks

  • +6 more secondary outcomes

Study Arms (2)

iGrow Readers Curriculum

EXPERIMENTAL

The iGrow Readers nutrition and physical activity curriculum was implemented in early-childhood classrooms assigned to the IGrow Readers intervention group.

Other: iGrow Readers Curriculum

Standard Curriculum

NO INTERVENTION

The standard curriculum was provided within early-childhood classrooms assigned to the control group.

Interventions

As part of the iGrow Readers curriculum, the primary teacher first reads a book as a group with a specific health behavior theme. Then, children participate in nutrition and physical activities that relate and reinforce the lessons learned in the book. Informational newsletters highlighting healthy behaviors from the stories' themes are provided to parents. All implementation strategies are reinforced by research to promote positive choices in young children's health behaviors through the use of literature and language strategies and modeling of others in the children's microsystems.

iGrow Readers Curriculum

Eligibility Criteria

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

You may qualify if:

  • year old children attending a participating early childhood care facility. All early childhood care facilities had at least two classrooms available. All children provided assent and their participating guardian provided consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pediatric ObesityBehaviorMotor ActivityObesityLiteracy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCommunication

Study Officials

  • Jessica R Meendering, PhD

    South Dakota State University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 12, 2018

Study Start

August 14, 2014

Primary Completion

August 13, 2016

Study Completion

August 13, 2016

Last Updated

January 17, 2019

Record last verified: 2019-01