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School Nurse-directed Secondary Obesity Prevention for Elementary School Children

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ClinicalTrials.gov Identifier: NCT02029976
Recruitment Status : Active, not recruiting
First Posted : January 8, 2014
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Temple University

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.


Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together) Behavioral: Mailed monthly newsletters Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: School Nurse-directed Secondary Obesity Prevention for Elementary School Children
Study Start Date : April 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Active Comparator: attention control condition
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
Newsletters

Experimental: after school weight management program
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; and 4) collaboration with health care providers and community-based organizations that provide families opportunities for healthy eating and activity. Mailed monthly newsletters
Behavioral: SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together)
attention control condition after school weight management program




Primary Outcome Measures :
  1. Child Body Mass Index (BMI) [ Time Frame: Measurement data will be collected at baseline prior to randomization and 4 (child BMI only), 9 (child BMI only), 12, and 24 months post randomization ]
    Body Mass Index (primary outcome) is the recommended method of assessing overweight among adults and children and will be calculated with the formula: weight (kg)/height (m) 2. To determine child BMI percentile, we will calculate age- and gender-adjusted BMI with Centers for Disease Control and Prevention (CDC) growth charts (ANTHRO 1.01 software-CDC). The primary outcome measure will be change in BMI z-score.


Secondary Outcome Measures :
  1. child dietary intake [ Time Frame: Measurement data will be collected at baseline prior to randomization, and 12, and 24 months post randomization ]
    Dietary intake will be assessed with multiple 24-hour dietary recall interviews.

  2. Activity [ Time Frame: Activity data will be collected at baseline prior to randomization and 12, and 24 months post randomization ]
    Activity will be assessed with the MTI ActiGraph uniaxial accelerometer worn for a 7-day period

  3. Health-related Quality of Life [ Time Frame: Measurement data will be collected at baseline prior to randomization and 12, and 24 months post randomization ]
    We will use the 23-item pediatric QOL inventory, PedsQL 4.0 to assess physical, emotional, social and school functioning. Parents will complete the parallel parent proxy report.

  4. Psychosocial factors [ Time Frame: Data will be collected at baseline prior to randomization and 12, and 24 months post randomization ]
    Data will be collected via child and parent surveys.



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029976


Locations
United States, Massachusetts
University of Massachusetts Amherst
Amherst, Massachusetts, United States, 01003
United States, Minnesota
University of Minnesota School of Nursing
Minneapolis, Minnesota, United States, 55455
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Martha Kubik, PhD Temple University

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02029976     History of Changes
Other Study ID Numbers: 00029947
1R01NR013473-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms