NCT02029976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 23, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

5.3 years

First QC Date

January 6, 2014

Results QC Date

June 22, 2020

Last Update Submit

July 13, 2020

Conditions

OverweightObesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Dietary: Healthy Eating Index

    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

  • Activity

    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

  • Total 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

Study Arms (2)

attention control condition

ACTIVE COMPARATOR

Child and parent participants randomized to the attention control condition will receive a Newsletter Program or mailed monthly newsletter with general family-focused health information.

Behavioral: Mailed monthly newsletters

after school weight management program

EXPERIMENTAL

The 9-month after school weight management program called SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together), with a focus on healthy food and activity practices will be directed by a school nurse and will include: 1) quarterly parent/child coaching sessions with the school nurse held in the participant's home; 2) 14 child group sessions led by the school nurse, held in a school setting 1-2 times a month; 3) 5 parent group sessions led by a school nurse held in a school setting.

Behavioral: SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together)

Interventions

SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together)BEHAVIORAL

attention control condition after school weight management program

after school weight management program
Mailed monthly newslettersBEHAVIORAL

Newsletters

attention control condition

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • rd 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Massachusetts Amherst

Amherst, Massachusetts, 01003, United States

Location

University of Minnesota School of Nursing

Minneapolis, Minnesota, 55455, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (9)

  • 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.

    PMID: 28103183BACKGROUND

  • 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.

    PMID: 31756720BACKGROUND

  • 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.

    PMID: 31514567BACKGROUND

  • 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.

    PMID: 31056369BACKGROUND

  • 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.

    PMID: 30342255BACKGROUND

  • 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.

    PMID: 32200320BACKGROUND

  • 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.

    PMID: 29320346BACKGROUND

  • Lee J, Helgeson E, Horning ML, Elgesma KM, Kubik MY, Fulkerson JA. Food Insecurity and Changes in Diet Quality and Body Mass Index z-Scores Among Elementary School Students. Child Obes. 2024 Oct;20(7):508-516. doi: 10.1089/chi.2023.0185. Epub 2024 Mar 28.

    PMID: 38546529DERIVED

  • 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.

    PMID: 33601934DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Nurses

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Martha Y Kubik, Professor and Director School of Nursing
Organization
George Mason University, College of Health and Human Services
mkubik@gmu.edu
703-993-1971

Study Officials

  • Martha Kubik, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 8, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

July 23, 2020

Results First Posted

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(3)