search
Back to results

iGrow Readers Nutrition and Physical Activity Curriculum Efficacy

Primary Purpose

Pediatric Obesity, Knowledge, Attitudes, Practice, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iGrow Readers Curriculum
Sponsored by
South Dakota State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pediatric Obesity focused on measuring Obesity, Physical Activity, Nutrition, Curriculum, Preschool, Literacy

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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:

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    iGrow Readers Curriculum

    Standard Curriculum

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Change in Height
    Height was measured in cm via shorrboard.
    Change in Weight
    Weight was measured in kg on an electronic scale.
    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.
    Change in Body Mass Index
    Body Mass Index (kg/m^2) was calculated in adults and Body Mass Index Percentile was calculated in children.
    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.
    Change in Physical Activity
    Accelerometers were used for assessment of physical activity in children, their guardian, and their teacher.
    Change in Sedentary Behavior
    Accelerometers were used for assessment of sedentary behavior in children, their guardian, and their teacher.
    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").
    Home Environment - Nutrition and Physical Activity
    The home environment was assessed via the comprehensive home environment survey.
    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.
    Parenting Style
    The parenting dimensions inventory was used to assess parenting style in guardians.

    Full Information

    First Posted
    September 7, 2018
    Last Updated
    January 15, 2019
    Sponsor
    South Dakota State University
    Collaborators
    United States Department of Agriculture (USDA)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03668678
    Brief Title
    iGrow Readers Nutrition and Physical Activity Curriculum Efficacy
    Official Title
    iGrow Readers Nutrition and Physical Activity Curriculum Efficacy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 14, 2014 (Actual)
    Primary Completion Date
    August 13, 2016 (Actual)
    Study Completion Date
    August 13, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    South Dakota State University
    Collaborators
    United States Department of Agriculture (USDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pediatric Obesity, Knowledge, Attitudes, Practice, Physical Activity, Diet Modification
    Keywords
    Obesity, Physical Activity, Nutrition, Curriculum, Preschool, Literacy

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    568 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    iGrow Readers Curriculum
    Arm Type
    Experimental
    Arm Description
    The iGrow Readers nutrition and physical activity curriculum was implemented in early-childhood classrooms assigned to the IGrow Readers intervention group.
    Arm Title
    Standard Curriculum
    Arm Type
    No Intervention
    Arm Description
    The standard curriculum was provided within early-childhood classrooms assigned to the control group.
    Intervention Type
    Other
    Intervention Name(s)
    iGrow Readers Curriculum
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Nutrition and Physical Activity Knowledge
    Description
    The Child Nutrition and Physical Activity Survey Tool was used for assessment of nutrition and physical activity knowledge in children.
    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).
    Secondary Outcome Measure Information:
    Title
    Change in Height
    Description
    Height was measured in cm via shorrboard.
    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)
    Title
    Change in Weight
    Description
    Weight was measured in kg on an electronic scale.
    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)
    Title
    Change in Body Composition - Lean mass and fat mass
    Description
    Lean mass and fat mass were measured with bio-electrical impedance analysis in children, their guardian, and their teacher.
    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)
    Title
    Change in Body Mass Index
    Description
    Body Mass Index (kg/m^2) was calculated in adults and Body Mass Index Percentile was calculated in children.
    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)
    Title
    Teacher Perceptions of the Curriculum
    Description
    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.
    Time Frame
    up to 33 weeks
    Title
    Change in Physical Activity
    Description
    Accelerometers were used for assessment of physical activity in children, their guardian, and their teacher.
    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)
    Title
    Change in Sedentary Behavior
    Description
    Accelerometers were used for assessment of sedentary behavior in children, their guardian, and their teacher.
    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)
    Title
    Change in Diet
    Description
    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").
    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)
    Title
    Home Environment - Nutrition and Physical Activity
    Description
    The home environment was assessed via the comprehensive home environment survey.
    Time Frame
    up to 33 weeks
    Title
    Caregiver physical activity practices
    Description
    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.
    Time Frame
    up to 33 weeks
    Title
    Parenting Style
    Description
    The parenting dimensions inventory was used to assess parenting style in guardians.
    Time Frame
    up to 33 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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:
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jessica R Meendering, PhD
    Organizational Affiliation
    South Dakota State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    The research team has not determined if the individual participant data will be made available to other researchers at this time as we are still actively publishing from this dataset.

    Learn more about this trial

    iGrow Readers Nutrition and Physical Activity Curriculum Efficacy

    We'll reach out to this number within 24 hrs