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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR013473-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together) | Behavioral | attention control condition after school weight management program |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary: Healthy Eating Index | 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. | 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 |
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Inclusion Criteria for child participants:
Exclusion Criteria for child participants:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Kubik, PhD | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Amherst | Amherst | Massachusetts | 01003 | United States | ||
| University of Minnesota School of Nursing |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28103183 | Background | 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. | |
| 31756720 | Background | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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; |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| YR-1 Post Intervention vs Baseline |
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| ||||||||||||||||||
| YR-2 Follow Up vs Baseline |
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Per condition, at baseline, there were 66 child participants and 66 adult/parent participants .
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | After School Weight Management Program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.. | Analysis population for primary outcome of BMI Z-score was child participants. | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
Monitoring for adverse events occurred for each participant from baseline data collection to completion of follow up measurement and encompassed measurement and intervention activities.
Definitions as per clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martha Y Kubik, Professor and Director School of Nursing | George Mason University, College of Health and Human Services | 703-993-1971 | mkubik@gmu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2020 | Jun 22, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2020 | Jun 22, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D009726 | Nurses |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Mailed monthly newsletters | Behavioral | Newsletters |
|
| Activity | 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. | 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 | 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. | 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 |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| 31514567 | Background | 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. |
| 31056369 | Background | 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. |
| 30342255 | Background | 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. |
| 32200320 | Background | 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. |
| 29320346 | Background | 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. |
| 38546529 | Derived | 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. |
| 33601934 | Derived | 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. |
| NOT COMPLETED |
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|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMIz | Value of the primary outcome, child BMIz, at baseline. | Mean | Standard Deviation | units on a scale |
|
| 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. |
| OG001 | 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. |
|
|
| Secondary | Dietary: Healthy Eating Index | 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. | Child participants who completed 24-hour dietary recall at baseline and 12-months post randomization, following completion of the intervention | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
|
|
| Secondary | Activity | 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. | 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. | Posted | Mean | Standard Deviation | percentage of time | 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 |
|
|
|
| Secondary | Total Quality of Life | 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. | analysis population included children who provided survey data at baseline and 12- and 24-months post randomization | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
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|
| 0 |
| 132 |
| 0 |
| 132 |
| 0 |
| 132 |
| EG001 | 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; | 0 | 132 | 0 | 132 | 0 | 132 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
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| Black |
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| Other |
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| Hispanic |
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| Black |
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| Other |
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