Pediatric ObesityNCT03668678
iGrow Readers Nutrition and Physical Activity Curriculum Efficacy
A study testing iGrow Readers Curriculum in people with Pediatric Obesity and Knowledge, Attitudes, Practice, run by South Dakota State University.
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… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Knowledge, Attitudes, Practice, Physical Activity
- What is being tested?
- iGrow Readers Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- No sites listed yet
- Study dates
- 14 Aug 2014to 13 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
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.
Read the 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.
- Being tested
- iGrow Readers Curriculum
- Keywords
- Obesity, Physical Activity, Nutrition, Curriculum, Preschool, Literacy
- Medical subject headings
- Pediatric Obesity, Behavior, Motor Activity, Obesity, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iGrow Readers CurriculumOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: iGrow Readers Curriculum |
| Standard Curriculum | No intervention | The standard curriculum was provided within early-childhood classrooms assigned to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Height was measured in cm via shorrboard.
Measured: 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
Weight was measured in kg on an electronic scale.
Measured: 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
Lean mass and fat mass were measured with bio-electrical impedance analysis in children, their guardian, and their teacher.
Measured: 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
Body Mass Index (kg/m^2) was calculated in adults and Body Mass Index Percentile was calculated in children.
Measured: 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
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.
Measured: up to 33 weeks
Change in Physical Activity
Accelerometers were used for assessment of physical activity in children, their guardian, and their teacher.
Measured: 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
Accelerometers were used for assessment of sedentary behavior in children, their guardian, and their teacher.
Measured: 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
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").
Measured: 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
The home environment was assessed via the comprehensive home environment survey.
Measured: up to 33 weeks
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.
Measured: up to 33 weeks
Parenting Style
The parenting dimensions inventory was used to assess parenting style in guardians.
Measured: up to 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start14 Aug 2014
- Primary completion13 Aug 2016
- Study completion13 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Jessica Meendering, South Dakota State University
- Investigators
- Jessica R Meendering, PhD, Principal investigator, South Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668678
- Sponsor's protocol ID
- 1408008
- Other IDs
- 2011-67002-30202
- Status last verified
- Jan 2019
- First submitted
- 7 Sep 2018
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iGrow Readers Nutrition and Physical Activity Curriculum Efficacy
- ClinicalTrials.gov ID
- NCT03668678
- Acronym / sponsor ID
- 1408008
- Keywords
- Obesity, Physical Activity, Nutrition, Curriculum, Preschool, Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 14 Aug 2014 (actual)
- Primary completion
- 13 Aug 2016 (actual)
- Study completion
- 13 Aug 2016 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iGrow Readers Curriculum | Experimental | Other: iGrow Readers CurriculumThe iGrow Readers nutrition and physical activity curriculum was implemented in early-childhood classrooms assigned to the IGrow Readers intervention group. |
| Standard Curriculum | No intervention | –The standard curriculum was provided within early-childhood classrooms assigned to the control group. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iGrow Readers CurriculumAs 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. | Other | iGrow Readers Curriculum |
Primary outcome
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.
11 secondary outcomes
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)
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)
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)
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)
Teacher Perceptions of the Curriculum
Time frame: 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)
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)
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)
Home Environment - Nutrition and Physical Activity
Time frame: up to 33 weeks
Caregiver physical activity practices
Time frame: up to 33 weeks
Parenting Style
Time frame: up to 33 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica R Meendering, PhD principal investigator
South Dakota State University
Questions about this trial
What is this clinical trial studying?
A study testing iGrow Readers Curriculum in people with Pediatric Obesity and Knowledge, Attitudes, Practice, run by South Dakota State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2019.