School Nurse-directed Secondary Obesity Prevention for Elementary School Children

• Sponsor: Temple University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02029976
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 264
• Locations: 3
• Arms: 2
• Duration (Months): 64
• Patients Per Site: 88
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Apr 1, 2014
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

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.	Behavioral: SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together); attention control condition after school weight management program

Outcome Measures

Primary Outcome Measures

1. Child Body Mass Index (BMI) [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]

   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..

Secondary Outcome Measures

1. 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]

   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.

2. 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]

   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.

3. 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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Massachusetts Amherst	Amherst	Massachusetts	United States	01003
2	University of Minnesota School of Nursing	Minneapolis	Minnesota	United States	55455
3	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

Study Documents (Full-Text)

• Study Protocol - Jun 22, 2020
• Statistical Analysis Plan - Jun 22, 2020

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Temple University
• ClinicalTrials.gov Identifier: NCT02029976
• Other Study ID Numbers: 00029947; 1R01NR013473-01A1
• First Posted: Jan 8, 2014
• Last Update Posted: Jul 23, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Obesity; Overweight

Study Results

Participant Flow

Recruitment Details	Cohorts of children along with a parent were recruited annually from 2014 to 2017 and January through May, for a total of 4 cohorts. Data analyses of primary and secondary outcomes did not occur until cohort 4 completed the year 2: follow up measurement in August 2019.

Arm/Group Title	Attention Control Condition	After School Weight Management Program
Arm/Group Description	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.	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;
Period Title: YR-1 Post Intervention vs Baseline
STARTED	132	132
COMPLETED	120	124
NOT COMPLETED	12	8
Period Title: YR-1 Post Intervention vs Baseline
STARTED	132	132
COMPLETED	122	124
NOT COMPLETED	10	8

Baseline Characteristics

Arm/Group Title	Attention Control Condition	After School Weight Management Program	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	132	132	264
Age (Count of Participants)
<=18 years	66 50%	66 50%	132 50%
Between 18 and 65 years	66 50%	66 50%	132 50%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Child participants	9.3 (0.9)	9.3 (0.9)	9.3 (0.9)
Adult/parent participants	38.9 (6.7)	39.3 (7.4)	39.1 (7.1)
Sex: Female, Male (Count of Participants)
Female	31 23.5%	34 25.8%	65 24.6%
Male	35 26.5%	32 24.2%	67 25.4%
Female	61 46.2%	63 47.7%	124 47%
Male	5 3.8%	3 2.3%	8 3%
Race/Ethnicity, Customized (Count of Participants)
White	25 18.9%	24 18.2%	49 18.6%
Hispanic	15 11.4%	15 11.4%	30 11.4%
Black	15 11.4%	13 9.8%	28 10.6%
Other	11 8.3%	14 10.6%	25 9.5%
White	36 27.3%	40 30.3%	76 28.8%
Hispanic	14 10.6%	12 9.1%	26 9.8%
Black	8 6.1%	9 6.8%	17 6.4%
Other	8 6.1%	5 3.8%	13 4.9%
Region of Enrollment (participants) [Number]
United States	132 100%	132 100%	264 100%
BMIz (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.7 (0.7)	1.5 (0.6)	1.6 (0.7)

Outcome Measures

1. Primary Outcome

Title	Child Body Mass Index (BMI)
Description	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..
Time Frame	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

Outcome Measure Data

Analysis Population Description

Analysis population for primary outcome of BMI Z-score was child participants.

Arm/Group Title	Attention Control Condition	After School Weight Management Program
Arm/Group Description	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.	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.
Measure Participants	61	62
YR-1 Post Intervention	1.6 (0.7)	1.5 (0.7)
YR-2 Follow Up	1.7 (0.7)	1.6 (0.6)

2. Secondary Outcome

Title	Dietary: Healthy Eating Index
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

Child participants who completed 24-hour dietary recall at baseline and 12-months post randomization, following completion of the intervention

Arm/Group Title	Attention Control Condition	After School Weight Management Program
Arm/Group Description	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.	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.
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	47.6 (12.5)	51.9 (13.0)

3. Secondary Outcome

Title	Activity
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

Child participants were required to provide at least 480-minutes of wear time per day to represent a day of data. Participants with 2-3 days of wear time underwent a within-participant "imputation" method that used all available data to create a composite day.

Arm/Group Title	Attention Control Condition	After School Weight Management Program
Arm/Group Description	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.	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.
Measure Participants	51	50
Moderate or Vigorous Physical Activity (MVPA)	4.5 (2.7)	4.2 (2.9)
Sedentary Behavior	67.2 (8.5)	67.6 (8.2)

4. Secondary Outcome

Title	Total Quality of Life
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

analysis population included children who provided survey data at baseline and 12- and 24-months post randomization

Arm/Group Title	Attention Control Condition	After School Weight Management Program
Arm/Group Description	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.	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.
Measure Participants	61	62
Year One Post Intervention	76.0 (16.3)	72.3 (16.1)
Year Two Follow Up	78.3 (14.7)	77.0 (15.4)

Adverse Events

Time Frame	Monitoring for adverse events occurred for each participant from baseline data collection to completion of follow up measurement and encompassed measurement and intervention activities.
Adverse Event Reporting Description	Definitions as per clinicaltrials.gov
Arm/Group Title	Attention Control Condition		After School Weight Management Program
Arm/Group Description	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.		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;
All Cause Mortality
	Attention Control Condition		After School Weight Management Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/132 (0%)		0/132 (0%)
Serious Adverse Events
	Attention Control Condition		After School Weight Management Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/132 (0%)		0/132 (0%)
Other (Not Including Serious) Adverse Events
	Attention Control Condition		After School Weight Management Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/132 (0%)		0/132 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.