School Nurse-directed Secondary Obesity Prevention for Elementary School Children

Obesity Clinical Trial

Official title:

School Nurse-directed Secondary Obesity Prevention for Elementary School Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029976
• Other study ID #: 00029947
• Secondary ID: 1R01NR013473-01A
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: August 2019

Study information

• Verified date: July 2020
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Aim: To test the efficacy of an elementary school-based, school nurse-led weight management program to reduce excess weight gain among children, 8 to 12 years old who are overweight and at risk of overweight by increasing healthy dietary practices and physical activity levels and decreasing sedentary practices.

Primary Hypothesis: Relative to the control condition, the children receiving the intervention will have a significantly lower body mass index (BMI), following implementation of the 9-month intervention, controlling for baseline values.

Description:

Primary Hypothesis: Relative to the control condition, the children receiving the intervention will have a significantly lower body mass index (BMI), following implementation of the 9-month intervention, controlling for baseline values.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria for child participants:

• 3rd 4th and 5th grade student the year the intervention is implemented,

• = 8 and = 12 years old,

• age- and gender-adjusted BMI = 75th percentile,

• child must live in a primary residence with the participating parent

Exclusion Criteria for child participants:

• plans to move outside the school district within the next 12 months,

• food allergies,

• physical limitations,

• medical conditions that prohibit participation in the intervention program or measurement,

• does not speak and write in English.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together)
attention control condition after school weight management program
• Mailed monthly newsletters
Newsletters

Locations

Country	Name	City	State
United States	University of Massachusetts Amherst	Amherst	Massachusetts
United States	University of Minnesota School of Nursing	Minneapolis	Minnesota
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Dozier SGH, Schroeder K, Lee J, Fulkerson JA, Kubik MY. The Association between Parents and Children Meeting Physical Activity Guidelines. J Pediatr Nurs. 2020 May - Jun;52:70-75. doi: 10.1016/j.pedn.2020.03.007. Epub 2020 Mar 19. — View Citation

Kubik MY, Fulkerson JA, Sirard JR, Garwick A, Temple J, Gurvich O, Lee J, Dudovitz B. School-based secondary prevention of overweight and obesity among 8- to 12-year old children: Design and sample characteristics of the SNAPSHOT trial. Contemp Clin Trials. 2018 Dec;75:9-18. doi: 10.1016/j.cct.2018.10.011. Epub 2018 Oct 18. — View Citation

Kubik MY, Gurvich OV, Fulkerson JA. Association Between Parent Television-Viewing Practices and Setting Rules to Limit the Television-Viewing Time of Their 8- to 12-Year-Old Children, Minnesota, 2011-2015. Prev Chronic Dis. 2017 Jan 19;14:E06. doi: 10.5888/pcd14.160235. — View Citation

Lee J, Kubik MY, Fulkerson JA. Diet Quality and Fruit, Vegetable, and Sugar-Sweetened Beverage Consumption by Household Food Insecurity among 8- to 12-Year-Old Children during Summer Months. J Acad Nutr Diet. 2019 Oct;119(10):1695-1702. doi: 10.1016/j.jand.2019.03.004. Epub 2019 May 2. — View Citation

Lee J, Kubik MY, Fulkerson JA. Media Devices in Parents' and Children's Bedrooms and Children's Media Use. Am J Health Behav. 2018 Jan 1;42(1):135-143. doi: 10.5993/AJHB.42.1.13. — View Citation

Lee J, Kubik MY, Fulkerson JA. Missed Work Among Caregivers of Children With a High Body Mass Index: Child, Parent, and Household Characteristics. J Sch Nurs. 2019 Sep 12:1059840519875506. doi: 10.1177/1059840519875506. [Epub ahead of print] — View Citation

Schroeder K, Kubik MY, Lee J, Sirard JR, Fulkerson JA. Self-Efficacy, Not Peer or Parent Support, Is Associated With More Physical Activity and Less Sedentary Time Among 8- to 12-Year-Old Youth With Elevated Body Mass Index. J Phys Act Health. 2020 Jan 1;17(1):74-79. doi: 10.1123/jpah.2019-0108. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Body Mass Index (BMI)	Body Mass Index (primary outcome) is the recommended method of assessing overweight among children and was calculated with the formula: weight (kg)/height (m) 2. To determine child BMI percentile, we calculated age- and gender-adjusted BMI with Centers for Disease Control and Prevention (CDC) growth charts.. The primary outcome measure is BMI Z-Score, which indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A higher Z-score is a less favorable outcome when assessing overweight/obesity across conditions in a healthy weight management intervention..	Measurement data will be collected at baseline prior to randomization and 12 (YR-1 post intervention), and 24 (YR-2 follow up) months post randomization
Secondary	Dietary: Healthy Eating Index	The Healthy Eating Index-2015 (HEI-2015) will be assessed with multiple 24-hour dietary recall interviews. A score on the HEI-2015 ranges from 0 to 100, with 100 meeting the recommendations for all 13 components of the HEI-2015. The higher the score the better.	The measure was collected at 12 months (YR-1 post intervention) following randomization with result adjusted for baseline value, percent body fat, sex and economic assistance
Secondary	Activity	Activity will be assessed with the MTI ActiGraph uniaxial accelerometer worn for a 7-day period. Time spent in each category of sedentary or moderate-vigorous physical activity was calculated as a percent of total wear time, with higher numbers indicating more time spent in the category.	The measure was collected at 12 months (YR-1 post intervention), following randomization with result adjusted for baseline value, percent body fat, sex and age
Secondary	Total Quality of Life	The 23-item Pediatric Quality of Life (QOL) child inventory or PedsQL 4.0 was used to assess physical, emotional, social and school functioning. Responses are reversed scored and transformed to a 0 to 100 scale which is used to calculate a total health-related quality of life summary score (mean of 23 items) which includes a physical health summary score (mean of 8 physical functioning items) and psycho-social health summary score (mean of 15 emotional, social and school functioning items). A higher score indicates better child-reported health-related quality of life.	Measurement data will be collected at baseline prior to randomization and 12 (YR-1 post intervention) , and 24 (YR-2 follow up) months following randomization