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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- 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.
- 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.
- 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
- 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.
- 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.
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
|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|
|Philadelphia, Pennsylvania, United States, 19140|
|Principal Investigator:||Martha Kubik, PhD||Temple University|