- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03668678
iGrow Readers Nutrition and Physical Activity Curriculum Efficacy
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
iGrow Readers was created to support literacy development among preschoolers, while promoting nutrition and physical activity messages. This program utilizes the social cognitive theory because it focuses on different environments influencing individual's behaviors and knowledge acquisitions, primarily through observing others within the context of social interactions and experiences. Developmentally appropriate preschool-aged children books, including relevant Native American books, facilitate the themes of healthy physical activity and nutrition practices. The program, a 6-8-week educational curriculum, helps young children understand the benefits of making healthy decisions involving nutrition and physical activity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
3-5 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.
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iGrow Readers Curriculum
The iGrow Readers nutrition and physical activity curriculum was implemented in early-childhood classrooms assigned to the IGrow Readers intervention group.
|
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.
|
No Intervention: Standard Curriculum
The standard curriculum was provided within early-childhood classrooms assigned to the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Nutrition and Physical Activity Knowledge
Time Frame: 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).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Height
Time Frame: 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)
|
Height was measured in cm via shorrboard.
|
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
Time Frame: 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)
|
Weight was measured in kg on an electronic scale.
|
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
Time Frame: 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)
|
Lean mass and fat mass were measured with bio-electrical impedance analysis in children, their guardian, and their teacher.
|
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
Time Frame: 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)
|
Body Mass Index (kg/m^2) was calculated in adults and Body Mass Index Percentile was calculated 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)
|
Teacher Perceptions of the Curriculum
Time Frame: up to 33 weeks
|
The Teacher Feedback Questionnaire was used to evaluate teacher perceptions, ideas, and events related to iGrow Readers.
The questionnaire consisted of 26 questions that asked teachers about the changes they may have noticed in their children and themselves, and if they modeled nutrition-based changes for their children after the program's implementation.
In addition, teachers were asked to rate the children's responsiveness to the program, if they planned to spend more time on nutrition and PA education in the classroom, and what components of the program the teachers and children enjoyed the most.
|
up to 33 weeks
|
Change in Physical Activity
Time Frame: 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)
|
Accelerometers were used for assessment of physical activity in children, their guardian, and their teacher.
|
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 Sedentary Behavior
Time Frame: 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)
|
Accelerometers were used for assessment of sedentary behavior in children, their guardian, and their teacher.
|
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 Diet
Time Frame: 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)
|
The Harvard Service Food Frequency Questionnaire (HSFFQ) was used to assess dietary behaviors and was completed by teachers and guardians.
Teachers provided responses about themselves and the guardians provided responses about themselves and on behalf of their child.
The questionnaire lists 87 different food items for adults (86 for children) and ask the number of times the food was consumed during the past 4 weeks.
Each food item has a response scale of 0 to 8 (0 = "Never"; 1 = "1-3 times/month"; 2 = "1 time/week"; 3 = "2-4 times/week"; 4 = "5-6 times/week"; 5 = "1 time/day"; 6 = "2-3 times/day"; 7 = "4-5 times/day"; and 8 = "more than 6 times/day").
|
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)
|
Home Environment - Nutrition and Physical Activity
Time Frame: up to 33 weeks
|
The home environment was assessed via the comprehensive home environment survey.
|
up to 33 weeks
|
Caregiver physical activity practices
Time Frame: up to 33 weeks
|
Caregiver physical activity practices were assessed via the parent report version of the Activity Support Scale for Multiple Groups (ACTS-MG).
The ACTS-MG measures parental support for children's physical activity and includes the following sub-scales: modeling, logistical support, and restricting access to screen-based activities.
Each of the 20 items on the questionnaire has a response scale of 1 (strongly disagree) to 4 (strongly agree).
The overall score is a mean score across all questions and subscale scores are mean scores of the questions within the subscale.
The higher the score, the greater the parental support for physical activity of the child.
|
up to 33 weeks
|
Parenting Style
Time Frame: up to 33 weeks
|
The parenting dimensions inventory was used to assess parenting style in guardians.
|
up to 33 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jessica R Meendering, PhD, South Dakota State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1408008
- 2011-67002-30202 (Other Identifier: USDA National Institute of Food and Agriculture)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Activity
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
-
University of Colorado, DenverCompletedPhysical Activity | Physical ImpairmentUnited States
-
PXL University CollegeHasselt UniversityNot yet recruitingPhysical Activity - Digital Phenotyping - Activity Tracking
-
University of ExtremaduraThe Spanish Ministry of Science, Innovation and UniversitiesRecruitingPhysical Activity | Cognition | Physical Fitness | AdolescentsSpain
-
AdventHealth Translational Research InstituteWake Forest UniversityRecruiting
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruitingPhysical ActivityUnited States
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruiting
Clinical Trials on iGrow Readers Curriculum
-
Penn State UniversityNational Institute on Drug Abuse (NIDA); Ohio State UniversityCompleted
-
University of ChicagoActive, not recruitingLanguage Environments of Children of Low-socioeconomic StatusUnited States
-
University Hospitals Cleveland Medical CenterAmerican Academy of Pediatrics; Mt. Sinai Health Care FoundationCompleted
-
University of WarwickPublic Health EnglandEnrolling by invitationBreast Cancer | Ductal Carcinoma in SituUnited Kingdom
-
Weill Medical College of Cornell UniversityCompletedPediatric Residents Rotating in Pediatric OncologyUnited States
-
Unity Health TorontoRecruiting
-
Mayo ClinicNational Center for Research Resources (NCRR)Completed
-
Public Health Institute, CaliforniaUniversity of Southern California; Ford Foundation; Planned Parenthood Los AngelesCompletedSexually Transmitted Diseases | PregnancyUnited States
-
University of GeorgiaRecruitingHealthy | Healthy Lifestyle | Behavior, Child | Childhood ALLUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoRobert Wood Johnson Foundation; Kohl's Cares for Kids Safety NetworkCompleted