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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| University of California | OTHER |
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It is widely argued that the promotion of water consumption, as an alternative to sugar-sweetened beverages, can assist in childhood obesity prevention efforts. Yet no studies have tested this argument in real world schools where flavored milk or juices are available. This trial will fill gaps by examining how promoting fresh water intake-both in schools that do and do not provide access to caloric beverages -impacts children's consumption of food and beverages both during and outside of school, and obesity.
Maintaining a healthy weight is important for young children because childhood obesity is predictive of adult obesity and related chronic illness. Intake of sugar-sweetened beverages (SSBs: sodas, flavored milks, fruit-flavored drinks, and other drinks with added sugar) is a major contributor to obesity. This is particularly true for low income children who are more likely to drink SSBs and to be obese. Children spend substantial time in schools where they consume up to 50% of daily calories, including those from SSBs. Consequently, many obesity prevention efforts have targeted reductions in SSB intake in schools. Recently, scientific authorities have also recommended that schools improve the availability of potable and free drinking water - a healthy alternative to SSBs - as a low-cost and feasible obesity prevention strategy. Emerging policies also mandate water access in schools; but implementation is poor. Although the 2010 Healthy, Hunger-Free Kids Act requires schools participating in federal meal programs to provide free potable water where meals are served, 25% of US schools still fail to do so. And even in schools that offer free water, drinking fountains may be avoided due to concerns about cleanliness or sub-standard water quality. While promotion of drinking water intake in schools is a plausible obesity prevention strategy, no large studies have systematically examined how this tactic can change children's overall dietary patterns and obesity rates in schools that offer SSBs and juices. This study's central hypothesis is that in elementary schools, increased access to fresh water and rigorous promotion of its consumption will reduce student intake of caloric beverages, thereby leading to lower rates of obesity. This hypothesis will be tested through a cluster-randomized trial in 26 low-income elementary schools in the San Francisco Bay Area, in which 13 schools will receive a water promotion intervention and 13 schools will serve as controls. The intervention, based on Social Cognitive Theory and the PRECEDE-PROCEED Model and cultivated in the investigators' prior developmental studies, promotes water consumption by: 1) installing lead-free water stations in cafeterias, physical activity spaces and high-traffic common areas, 2) providing cups and reusable water bottles for students, and 3) conducting a 6-month health education campaign that includes a kick-off play, class lessons, family homework activities, signage, and rewards. From baseline to 7 and 15 months after the start of the intervention, researchers measure differences in: 1) water intake (observations and measurements of water taken from water sources) 2) water and SSB intake via beverage frequency questionnaires and 3) overweight/obesity prevalence between students in intervention and control schools. Total caloric intake from foods and beverages (24-hour food and beverage diaries) are measured at baseline and 7 months only due to budget cuts and their resource intensiveness. If the proposed school water intervention is effective, school officials will have a feasible and low-cost obesity prevention tool. US schools will soon be federally mandated to reevaluate their wellness policies in order to implement new food and beverage regulations. This study presents a timely opportunity to provide leaders with an evidence-based strategy for improving student nutrition and health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water Access and Promotion - Students | Experimental | Intervention group will receive installation of water stations in high traffic areas, schoolwide promotion, and 4th graders will receive a curricula focused on increasing intake of water. |
|
| Control - Students | No Intervention | Participants do not receive an intervention | |
| School Personnel | No Intervention | School administrators and food service managers provide information on school policies and procedures. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water First | Behavioral | The Water First intervention consists of increased access to safe and appealing drinking water in schools, school-wide promotion to increase students' intake of water, and education directed to 4th grade students and their families to increase intake of water. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85% | Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. | Baseline, 7-months, and 15-months after the start of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No. | Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. | Baseline, 7-months, and 15-months after the start of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| School Policies and Practices | School administrators and food service director surveys of nutrition and physical activity policies and practices at schools | Baseline and 15-months after the start of the study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anisha Patel, MD, MSPH | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford | Stanford | California | 94305-5119 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35537674 | Background | Ezennia J, Schmidt LA, Ritchie LD, Blacker L, McCulloch CE, Patel AI. Water Security Experiences and Water Intake Among Elementary Students at Low-Income Schools: A Cross-Sectional Study. Acad Pediatr. 2023 Jan-Feb;23(1):68-75. doi: 10.1016/j.acap.2022.04.008. Epub 2022 May 7. | |
| 33370616 | Background | Moreno GD, Schmidt LA, Ritchie LD, McCulloch CE, Cabana MD, Brindis CD, Green LW, Altman EA, Patel AI. A cluster-randomized controlled trial of an elementary school drinking water access and promotion intervention: Rationale, study design, and protocol. Contemp Clin Trials. 2021 Feb;101:106255. doi: 10.1016/j.cct.2020.106255. Epub 2020 Dec 25. |
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1861 students and adults signed consent; 564 students and adults could not be in the study due to pandemic school closures.
Cluster-randomized trial: participants were enrolled from schools that were randomized to receive the intervention, or no intervention.
| ID | Title | Description |
|---|---|---|
| FG000 | Water Access and Promotion - Students | Schools receive installation of water stations in high traffic areas, schoolwide promotion, and 4th graders receive a curricula focused on increasing intake of water (intervention group). School personnel complete surveys on school policies and procedures. |
| FG001 | Control - Students | Schools do not receive the intervention. School personnel complete surveys on school policies and procedures. |
| FG002 | Food Service Directors | District-level Food Service Directors complete surveys on school policies and procedures. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Student who received allocated intervention or participated in allocated control, and adult participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Water Access and Promotion - Students | Schools receive installation of water stations in high traffic areas, schoolwide promotion, and 4th graders receive a curricula focused on increasing intake of water (intervention group). |
| BG001 | Water Access and Promotion - School Personnel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data were not gathered from the adult 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 | Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 85% | Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. | Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis. | Posted | Count of Participants | Participants | Baseline, 7-months, and 15-months after the start of the study. |
|
15 months
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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 | Water Access and Promotion - Students | Schools receive installation of water stations in high traffic areas, schoolwide promotion, and 4th graders receive a curricula focused on increasing intake of water (intervention group). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | Cause of death not disclosed to research team due to privacy concern |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anisha Patel, MD | Stanford University | (650) 497-1181 | anipatel@stanford.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 | Feb 29, 2024 | Mar 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 29, 2024 | Mar 2, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 29, 2024 | Mar 2, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| BMI Percentile,Mean(SD) |
Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. |
| Baseline, 7-months, and 15-months after the start of the study. |
| BMI, Mean (SD) | Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. | Baseline, 7-months, and 15-months after the start of the study. |
| BMI Z-score, Mean (SD) | Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. BMI z-scores (or standard deviation scores) are used in anthropometry to quantify a measurement's distance from the mean. The measurement is obtained using the sex, age, weight and height of the participants. The z-score is based on United States Centers for Disease Control and Prevention growth references for children. A z-score of 0 reflects the 50th percentile based on the reference growth charts. For example, a z-score of 1.5 indicates a child is 1.5 standard deviations above the average value, whereas a z-score of -1.5 means a child is 1.5 standard deviations below the average value. | Baseline, 7-months, and 15-months after the start of the study. |
| Caloric Intake | Food and beverage diaries will be used to calculate daily caloric intake from foods and beverages. | Baseline and 7-months after the start of the study |
| Water Intake - Grams Consumed | Food and beverage diaries will be used to calculate daily water intake. | Baseline and 7-months |
| Beverage Intake | Beverage intake frequency questionnaires will be used to calculate past-week frequency of beverages consumed (times per day). | Baseline, 7-months, and 15-months after the start of the study. |
| Water Intake | Direct observations of water consumed at lunchtime, 4th-grade physical education (PE) classes, and recess. Researchers tallied the number of students using water sources and the student census in the area to estimate the proportion using stations or fountains. | Baseline, 7-months, and 15-months after the start of the study. |
| 37545466 | Result | Patel AI, Schmidt LA, McCulloch CE, Blacker LS, Cabana MD, Brindis CD, Ritchie LD. Effectiveness of a School Drinking Water Promotion and Access Program for Overweight Prevention. Pediatrics. 2023 Sep 1;152(3):e2022060021. doi: 10.1542/peds.2022-060021. |
| 42288871 | Derived | Gupta A, Ryu K, Peralta Y, Ordonez V, McCulloch CE, Schmidt LA, Ritchie LD, Patel AI. Fidelity evaluation of the Water First intervention for promoting tap water consumption in school-age children. BMC Public Health. 2026 Jun 13. doi: 10.1186/s12889-026-28101-w. Online ahead of print. |
Schools receive installation of water stations in high traffic areas, schoolwide promotion (intervention group). School personnel complete surveys on school policies and procedures. |
| BG002 | Control - Students | Schools do not receive an intervention. |
| BG003 | Control - School Personnel | Schools do not receive an intervention. School personnel complete surveys on school policies and procedures. |
| BG004 | Food Service Directors | District-level Food Service Directors complete surveys on school policies and procedures. |
| BG005 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race/ethnicity data were not gathered from the adult participants. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Control - Students |
Participants do not receive an intervention |
|
|
|
| Secondary | Number of Participants With Age- and Sex-adjusted BMI% Greater Than or Equal to 95%. Yes or No. | Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. | Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis. | Posted | Count of Participants | Participants | Baseline, 7-months, and 15-months after the start of the study. |
|
|
|
|
| Secondary | BMI Percentile,Mean(SD) | Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. | Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | BMI-for-age/sex percentile | Baseline, 7-months, and 15-months after the start of the study. |
|
|
|
|
| Secondary | BMI, Mean (SD) | Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. | Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, 7-months, and 15-months after the start of the study. |
|
|
|
|
| Secondary | BMI Z-score, Mean (SD) | Trained research staff will measure students' heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. BMI z-scores (or standard deviation scores) are used in anthropometry to quantify a measurement's distance from the mean. The measurement is obtained using the sex, age, weight and height of the participants. The z-score is based on United States Centers for Disease Control and Prevention growth references for children. A z-score of 0 reflects the 50th percentile based on the reference growth charts. For example, a z-score of 1.5 indicates a child is 1.5 standard deviations above the average value, whereas a z-score of -1.5 means a child is 1.5 standard deviations below the average value. | Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | z-score | Baseline, 7-months, and 15-months after the start of the study. |
|
|
|
|
| Secondary | Caloric Intake | Food and beverage diaries will be used to calculate daily caloric intake from foods and beverages. | Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | kcal/day | Baseline and 7-months after the start of the study |
|
|
|
|
| Secondary | Water Intake - Grams Consumed | Food and beverage diaries will be used to calculate daily water intake. | Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | grams/day | Baseline and 7-months |
|
|
|
|
| Secondary | Beverage Intake | Beverage intake frequency questionnaires will be used to calculate past-week frequency of beverages consumed (times per day). | Outcome measure data were collected from students only. Participants with data at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | times per day | Baseline, 7-months, and 15-months after the start of the study. |
|
|
|
|
| Secondary | Water Intake | Direct observations of water consumed at lunchtime, 4th-grade physical education (PE) classes, and recess. Researchers tallied the number of students using water sources and the student census in the area to estimate the proportion using stations or fountains. | Data were collected from students from participating schools, whether the students were enrolled in the study, or not. For each observation type (lunchtime, PE class, and recess) and period, the number estimated in the census at each respective time point are included in the analysis. Outcome measure data were not collected from adults. | Posted | Mean | Standard Deviation | observations | Baseline, 7-months, and 15-months after the start of the study. |
|
|
|
|
| Other Pre-specified | School Policies and Practices | School administrators and food service director surveys of nutrition and physical activity policies and practices at schools | Not Posted | Baseline and 15-months after the start of the study | Participants |
| 1 |
| 680 |
| 1 |
| 680 |
| 0 |
| 680 |
| EG001 | Water Access and Promotion - School Personnel | Schools receive installation of water stations in high traffic areas, schoolwide promotion (intervention group). School personnel complete surveys on school policies and procedures. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Control - Students | Schools do not receive an intervention. | 0 | 582 | 0 | 582 | 0 | 582 |
| EG003 | Control - School Personnel | Schools do not receive an intervention. School personnel complete surveys on school policies and procedures. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG004 | Food Service Directors | District-level Food Service Directors complete surveys on school policies and procedures. | 0 | 13 | 0 | 13 | 0 | 13 |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Non-Hispanic Black |
|
| Non-Hispanic White |
|
| Other (including American Indian or Alaska Native) |
|
| Month 7 |
|
|
| Month 15 |
|
|
| Mixed Models Analysis |
| .98 |
| Odds Ratio (OR) |
| 1.0 |
| 2-Sided |
| 95 |
| 0.1 |
| 7.0 |
| Superiority |
| Month 7 |
|
|
| Month 15 |
|
|
| Mixed Models Analysis |
| .40 |
| Adjusted mean difference |
| -0.5 |
| 2-Sided |
| 95 |
| -1.5 |
| 0.6 |
| Superiority |
| Month 7 |
|
|
| Month 15 |
|
|
| Mixed Models Analysis |
| .80 |
| Adjusted mean difference |
| -0.02 |
| 2-Sided |
| 95 |
| -0.2 |
| 0.1 |
| Superiority |
| Month 7 |
|
|
| Month 15 |
|
|
| Mixed Models Analysis |
| .36 |
| Adjusted mean difference |
| -0.02 |
| 2-Sided |
| 95 |
| -0.06 |
| 0.02 |
| Superiority |
| Total - month 7 |
|
|
| Food - baseline |
|
|
| Food - month 7 |
|
|
| Beverage - baseline |
|
|
| Beverage - month 7 |
|
|
| Sugar-sweetened beverage (SSB) - baseline |
|
|
| SSB - month 7 |
|
|
Analysis of between group change in intake of food kcal from baseline to 7 months. |
| Mixed Models Analysis |
| .35 |
Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time. |
| Percent difference in change |
| 3.7 |
| 2-Sided |
| 95 |
| -3.9 |
| 12.0 |
| Superiority |
| Analysis of between group change in intake of beverage kcal from baseline to 7 months. | Mixed Models Analysis | .35 | Percent difference in change | -10.6 | 2-Sided | 95 | -29.2 | 8.8 | Superiority |
| Analysis of between group change in SSB kcal from baseline to 7 months. | Mixed Models Analysis | .18 | Percent difference in change | -17.5 | 2-Sided | 95 | -37.8 | 9.6 | Superiority |
| Month 7 |
|
|
| Water - month 7 |
|
|
| Water - month 15 |
|
|
| SSB - baseline |
|
|
| SSB - month 7 |
|
|
| SSB - month 15 |
|
|
| Juice - baseline |
|
|
| Juice - month 7 |
|
|
| Juice - month 15 |
|
|
| Flavored milk - baseline |
|
|
| Flavored milk - month 7 |
|
|
| Flavored milk - month 15 |
|
|
| Plain milk - baseline |
|
|
| Plain milk - month 7 |
|
|
| Plain milk - month 15 |
|
|
| Mixed Models Analysis |
| .004 |
| Percent difference in change |
| 14.7 |
| 2-Sided |
| 95 |
| 4.5 |
| 25.9 |
| Superiority |
| Analysis of between group change in SSB intake from baseline to 7 months. | Mixed Models Analysis | 0.063 | Percent difference in change | -8.0 | 2-Sided | 95 | -15.7 | 0.4 | Superiority |
| Analysis of between group change in SSB intake from baseline to 15 months. | Mixed Models Analysis | .56 | Percent difference in change | -2.8 | 2-Sided | 95 | -11.7 | 6.9 | Superiority |
| Analysis of between group change in juice intake from baseline to 7 months. | Mixed Models Analysis | .68 | Percent difference in change | 1.2 | 2-Sided | 95 | -4.3 | 7 | Superiority |
| Analysis of between group change in juice intake from baseline to 15 months. | Mixed Models Analysis | .66 | Percent difference in change | -1.4 | 2-Sided | 95 | -7.4 | 5 | Superiority |
| Analysis of between group change in flavored milk intake from baseline to 7 months. | Mixed Models Analysis | 0.079 | Percent difference in change | -4.0 | 2-Sided | 95 | -8.3 | 0.5 | Superiority |
| Analysis of between group change in flavored milk intake from baseline to 15 months. | Mixed Models Analysis | .26 | Percent difference in change | -3.0 | 2-Sided | 95 | -8.0 | 2.3 | Superiority |
| Analysis of between group change in plain milk intake from baseline to 7 months. | Mixed Models Analysis | .20 | Percent difference in change | 4.4 | 2-Sided | 95 | -2.2 | 11.5 | Superiority |
| Analysis of between group change in plain milk intake from baseline to 15 months. | Mixed Models Analysis | .51 | Percent difference in change | 2.3 | 2-Sided | 95 | -4.4 | 9.6 | Superiority |
| Lunch - month 7 |
|
|
| Lunch - month 15 |
|
|
| Recess - baseline |
|
|
| Recess - month 7 |
|
|
| Recess - month 15 |
|
|
| PE class - baseline |
|
|
| PE class - month 7 |
|
|
| PE class - month 15 |
|
|
| Mixed Models Analysis |
| .22 |
| Percent difference in change |
| 4.9 |
| 2-Sided |
| 95 |
| -3.0 |
| 13.5 |
| Superiority |
| Analysis of between group change in water intake from water source at recess from baseline to 7 months. | Mixed Models Analysis | .02 | Percent difference in change | 17.0 | 2-Sided | 95 | 2.6 | 33.3 | Superiority |
| Analysis of between group change in water intake from water source at recess from baseline to 15 months. | Mixed Models Analysis | .48 | Percent difference in change | 4.7 | 2-Sided | 95 | -8.0 | 19.2 | Superiority |
| Analysis of between group change in water intake from water source at PE from baseline to 7 months. | Mixed Models Analysis | .14 | Percent difference in change | 34.6 | 2-Sided | 95 | -9.4 | 99.8 | Superiority |
| Analysis of between group change in water intake from water source at PE from baseline to 15 months. | Mixed Models Analysis | .16 | Percent difference in change | 32.1 | 2-Sided | 95 | -11.0 | 96.2 | Superiority |