Clinical trial NCT02029976: School Nurse-directed Secondary Obesity Prevention for Elementary School Children
Official title: School Nurse-directed Secondary Obesity Prevention for Elementary School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2014-01-08
Enrollment: 264
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Child Body Mass Index (BMI)
timeFrame: 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 outcomes:
measure: Dietary: Healthy Eating Index
timeFrame: 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
measure: Activity
timeFrame: 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
measure: Total Quality of Life
timeFrame: 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
Other outcomes:
Locations:
city: Amherst
country: United States
facility: University of Massachusetts Amherst
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota School of Nursing
state: Minnesota
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Martha Kubik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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. 2021 Oct;37(5):396-403. doi: 10.1177/1059840519875506. Epub 2019 Sep 12.
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.
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.
citation: 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.
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.
citation: Kubik MY, Lee J, Fulkerson JA, Gurvich OV, Sirard JR. School-Based Secondary Obesity Prevention for Eight- to Twelve-Year-Olds: Results from the Students, Nurses, and Parents Seeking Healthy Options Together Randomized Trial. Child Obes. 2021 Apr;17(3):185-195. doi: 10.1089/chi.2020.0321. Epub 2021 Feb 18.