Trial Outcomes & Findings for School Nurse-directed Secondary Obesity Prevention for Elementary School Children (NCT NCT02029976)

NCT ID: NCT02029976

Last Updated: 2020-07-23

Results Overview

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..

Recruitment status

COMPLETED

Study phase

Target enrollment

264 participants

Primary outcome timeframe

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

Results posted on

2020-07-23

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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;
YR-1 Post Intervention vs Baseline STARTED	132	132
YR-1 Post Intervention vs Baseline COMPLETED	120	124
YR-1 Post Intervention vs Baseline NOT COMPLETED	12	8
YR-2 Follow Up vs Baseline STARTED	132	132
YR-2 Follow Up vs Baseline COMPLETED	122	124
YR-2 Follow Up vs Baseline NOT COMPLETED	10	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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;
YR-1 Post Intervention vs Baseline Lost to Follow-up	12	8
YR-2 Follow Up vs Baseline Lost to Follow-up	8	4
YR-2 Follow Up vs Baseline Withdrawal by Subject	2	2
YR-2 Follow Up vs Baseline Moved from area	0	2

Baseline Characteristics

Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Attention Control Condition n=61 Participants 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 n=62 Participants 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.
Child Body Mass Index (BMI) YR-1 Post Intervention	1.6 units on a scale Standard Deviation 0.7	1.5 units on a scale Standard Deviation 0.7
Child Body Mass Index (BMI) YR-2 Follow Up	1.7 units on a scale Standard Deviation 0.7	1.6 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 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

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

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.

Outcome measures

Outcome measures
Measure	Attention Control Condition n=55 Participants 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 n=55 Participants 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.
Dietary: Healthy Eating Index	47.6 units on a scale Standard Deviation 12.5	51.9 units on a scale Standard Deviation 13.0

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Attention Control Condition n=51 Participants 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 n=50 Participants 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.
Activity Moderate or Vigorous Physical Activity (MVPA)	4.5 percentage of time Standard Deviation 2.7	4.2 percentage of time Standard Deviation 2.9
Activity Sedentary Behavior	67.2 percentage of time Standard Deviation 8.5	67.6 percentage of time Standard Deviation 8.2

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Attention Control Condition n=61 Participants 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 n=62 Participants 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 Quality of Life Year One Post Intervention	76.0 units on a scale Standard Deviation 16.3	72.3 units on a scale Standard Deviation 16.1
Total Quality of Life Year Two Follow Up	78.3 units on a scale Standard Deviation 14.7	77.0 units on a scale Standard Deviation 15.4

Adverse Events

Attention Control Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

After School Weight Management Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Martha Y Kubik, Professor and Director School of Nursing

George Mason University, College of Health and Human Services

Phone: 703-993-1971

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Attention Control Condition n=132 Participants 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 n=132 Participants 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 n=264 Participants Total of all reporting groups
Age, Categorical <=18 years	66 Participants n=132 Participants	66 Participants n=132 Participants	132 Participants n=264 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=132 Participants	66 Participants n=132 Participants	132 Participants n=264 Participants
Age, Categorical >=65 years	0 Participants n=132 Participants	0 Participants n=132 Participants	0 Participants n=264 Participants
Age, Continuous Child participants	9.3 years STANDARD_DEVIATION 0.9 • n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	9.3 years STANDARD_DEVIATION 0.9 • n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	9.3 years STANDARD_DEVIATION 0.9 • n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Age, Continuous Adult/parent participants	38.9 years STANDARD_DEVIATION 6.7 • n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	39.3 years STANDARD_DEVIATION 7.4 • n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	39.1 years STANDARD_DEVIATION 7.1 • n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Sex: Female, Male Child participants · Female	31 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	34 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	65 Participants n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Sex: Female, Male Child participants · Male	35 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	32 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	67 Participants n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Sex: Female, Male Adult/parent participants · Female	61 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	63 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	124 Participants n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Sex: Female, Male Adult/parent participants · Male	5 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	3 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	8 Participants n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Race/Ethnicity, Customized Child participants · White	25 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	24 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	49 Participants n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Race/Ethnicity, Customized Child participants · Hispanic	15 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	15 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	30 Participants n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Race/Ethnicity, Customized Child participants · Black	15 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	13 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	28 Participants n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Race/Ethnicity, Customized Child participants · Other	11 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	14 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	25 Participants n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Race/Ethnicity, Customized Adult/parent participants · White	36 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	40 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	76 Participants n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Race/Ethnicity, Customized Adult/parent participants · Hispanic	14 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	12 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	26 Participants n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Race/Ethnicity, Customized Adult/parent participants · Black	8 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	9 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	17 Participants n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Race/Ethnicity, Customized Adult/parent participants · Other	8 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	5 Participants n=66 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall	13 Participants n=132 Participants • Per condition, at baseline, there were 66 child participants and 66 adult/parent participants, totaling 132 per condition and 264 overall
Region of Enrollment United States	132 participants n=132 Participants	132 participants n=132 Participants	264 participants n=264 Participants
BMIz	1.7 units on a scale STANDARD_DEVIATION 0.7 • n=66 Participants • Value of the primary outcome, child BMIz, at baseline.	1.5 units on a scale STANDARD_DEVIATION 0.6 • n=66 Participants • Value of the primary outcome, child BMIz, at baseline.	1.6 units on a scale STANDARD_DEVIATION 0.7 • n=132 Participants • Value of the primary outcome, child BMIz, at baseline.