Physical Activity Clinical Trial
Official title:
iGrow Readers Nutrition and Physical Activity Curriculum Efficacy
Verified date | January 2019 |
Source | South Dakota State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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: |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
South Dakota State University | United States Department of Agriculture (USDA) |
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Active, not recruiting |
NCT03903874 -
Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
|
N/A | |
Recruiting |
NCT03662438 -
HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)
|
N/A | |
Withdrawn |
NCT04540523 -
Home-Based Exergaming Intervention
|
N/A | |
Recruiting |
NCT03250000 -
Changes in Microcirculation and Functional Status During Exacerbation of COPD
|
N/A | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Completed |
NCT05019482 -
Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time
|
N/A | |
Completed |
NCT03253406 -
Health Wearables and College Student Health
|
N/A | |
Not yet recruiting |
NCT05985460 -
A Very Brief Intervention to Increase the Intention to Practice Physical Activity
|
N/A | |
Completed |
NCT03380143 -
Whole-of-Community Youth Population Physical Activity
|
N/A | |
Completed |
NCT03700736 -
The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
|
N/A | |
Completed |
NCT03170921 -
Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals
|
N/A | |
Completed |
NCT04973813 -
Active Choice Intervention About Physical Activity for Physically Inactive Adults
|
N/A | |
Completed |
NCT03982095 -
Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
|
||
Completed |
NCT03271112 -
Frailty Prevention in Elders From Reunion Island
|
N/A | |
Completed |
NCT05670223 -
Healthy Activities Improve Lives
|
N/A | |
Completed |
NCT04894929 -
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
|
N/A | |
Recruiting |
NCT04578067 -
Empowering Immigrant Women for Active and Healthy Lifestyle
|
N/A | |
Completed |
NCT03297567 -
Physical Therapy Guidelines For Hospitalized Elderly
|
N/A |