Obesity, Overweight
Conditions
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.
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.
Interventions
BEHAVIORALSNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together)
attention control condition after school weight management program
BEHAVIORALMailed monthly newsletters
Newsletters
Sponsors
National Institute of Nursing Research (NINR)
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 132 |
| 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. | 132 |
| Total | 264 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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 | Moved from area | 0 | 2 |
| YR-2 Follow Up vs Baseline | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | After School Weight Management Program | Total | Attention Control Condition |
|---|---|---|---|
| Age, Categorical <=18 years | 66 Participants | 132 Participants | 66 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants | 132 Participants | 66 Participants |
| Age, Continuous Adult/parent participants | 39.3 years STANDARD_DEVIATION 7.4 | 39.1 years STANDARD_DEVIATION 7.1 | 38.9 years STANDARD_DEVIATION 6.7 |
| Age, Continuous Child participants | 9.3 years STANDARD_DEVIATION 0.9 | 9.3 years STANDARD_DEVIATION 0.9 | 9.3 years STANDARD_DEVIATION 0.9 |
| BMIz | 1.5 units on a scale STANDARD_DEVIATION 0.6 | 1.6 units on a scale STANDARD_DEVIATION 0.7 | 1.7 units on a scale STANDARD_DEVIATION 0.7 |
| Race/Ethnicity, Customized Adult/parent participants Black | 9 Participants | 17 Participants | 8 Participants |
| Race/Ethnicity, Customized Adult/parent participants Hispanic | 12 Participants | 26 Participants | 14 Participants |
| Race/Ethnicity, Customized Adult/parent participants Other | 5 Participants | 13 Participants | 8 Participants |
| Race/Ethnicity, Customized Adult/parent participants White | 40 Participants | 76 Participants | 36 Participants |
| Race/Ethnicity, Customized Child participants Black | 13 Participants | 28 Participants | 15 Participants |
| Race/Ethnicity, Customized Child participants Hispanic | 15 Participants | 30 Participants | 15 Participants |
| Race/Ethnicity, Customized Child participants Other | 14 Participants | 25 Participants | 11 Participants |
| Race/Ethnicity, Customized Child participants White | 24 Participants | 49 Participants | 25 Participants |
| Region of Enrollment United States | 132 participants | 264 participants | 132 participants |
| Sex: Female, Male Adult/parent participants Female | 63 Participants | 124 Participants | 61 Participants |
| Sex: Female, Male Adult/parent participants Male | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Child participants Female | 34 Participants | 65 Participants | 31 Participants |
| Sex: Female, Male Child participants Male | 32 Participants | 67 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 132 | 0 / 132 |
| other Total, other adverse events | 0 / 132 | 0 / 132 |
| serious Total, serious adverse events | 0 / 132 | 0 / 132 |
Outcome results
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..
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
Population: Analysis population for primary outcome of BMI Z-score was child participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control Condition | Child Body Mass Index (BMI) | YR-1 Post Intervention | 1.6 units on a scale | Standard Deviation 0.7 |
| Attention Control Condition | Child Body Mass Index (BMI) | YR-2 Follow Up | 1.7 units on a scale | Standard Deviation 0.7 |
| After School Weight Management Program | Child Body Mass Index (BMI) | YR-1 Post Intervention | 1.5 units on a scale | Standard Deviation 0.7 |
| After School Weight Management Program | Child Body Mass Index (BMI) | YR-2 Follow Up | 1.6 units on a scale | Standard Deviation 0.6 |
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.
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control Condition | Activity | Moderate or Vigorous Physical Activity (MVPA) | 4.5 percentage of time | Standard Deviation 2.7 |
| Attention Control Condition | Activity | Sedentary Behavior | 67.2 percentage of time | Standard Deviation 8.5 |
| After School Weight Management Program | Activity | Moderate or Vigorous Physical Activity (MVPA) | 4.2 percentage of time | Standard Deviation 2.9 |
| After School Weight Management Program | Activity | Sedentary Behavior | 67.6 percentage of time | Standard Deviation 8.2 |
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.
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
Population: Child participants who completed 24-hour dietary recall at baseline and 12-months post randomization, following completion of the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control Condition | Dietary: Healthy Eating Index | 47.6 units on a scale | Standard Deviation 12.5 |
| After School Weight Management Program | Dietary: Healthy Eating Index | 51.9 units on a scale | Standard Deviation 13 |
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.
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
Population: analysis population included children who provided survey data at baseline and 12- and 24-months post randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control Condition | Total Quality of Life | Year One Post Intervention | 76.0 units on a scale | Standard Deviation 16.3 |
| Attention Control Condition | Total Quality of Life | Year Two Follow Up | 78.3 units on a scale | Standard Deviation 14.7 |
| After School Weight Management Program | Total Quality of Life | Year One Post Intervention | 72.3 units on a scale | Standard Deviation 16.1 |
| After School Weight Management Program | Total Quality of Life | Year Two Follow Up | 77.0 units on a scale | Standard Deviation 15.4 |