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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03668678
Other study ID # 1408008
Secondary ID 2011-67002-30202
Status Completed
Phase N/A
First received
Last updated
Start date August 14, 2014
Est. completion date August 13, 2016

Study information

Verified date January 2019
Source South Dakota State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 568
Est. completion date August 13, 2016
Est. primary completion date August 13, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility 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 Design


Intervention

Other:
iGrow Readers Curriculum
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
South Dakota State University United States Department of Agriculture (USDA)

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in Height 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)
Secondary Change in Weight 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)
Secondary Change in Body Composition - Lean mass and fat mass 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)
Secondary Change in Body Mass Index 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)
Secondary Teacher Perceptions of the Curriculum 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
Secondary Change in Physical Activity 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)
Secondary Change in Sedentary Behavior 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)
Secondary Change in Diet 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)
Secondary Home Environment - Nutrition and Physical Activity The home environment was assessed via the comprehensive home environment survey. up to 33 weeks
Secondary Caregiver physical activity practices 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
Secondary Parenting Style The parenting dimensions inventory was used to assess parenting style in guardians. up to 33 weeks
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