Trial Outcomes & Findings for Kids SipSmartER, an Intervention to Reduce Sugar-sweetened Beverages (NCT NCT03740113)

NCT ID: NCT03740113

Last Updated: 2025-04-15

Results Overview

Change in ounces of sugar sweetened beverage consumption from Baseline to 7-months as measured via the validated Beverage Intake Questionnaire (BEVQ-15). Participants were asked to report how often and how much of the following sugary drinks they consumed in the past 30 days: regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks. Using standardized and validated scoring procedures, daily totals for each of the sugary beverages were determined by multiplying intake frequency by portion size. These daily total intakes were then summed across the five sugary drink types to obtain a total daily intake, in fluid ounces, of all sugary drinks. Change scores were calculated by subtracting the baseline sugary drink intake from the 7 month follow-up.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1013 participants

Primary outcome timeframe

Baseline and 7-months

Results posted on

2025-04-15

Participant Flow

Unit of analysis: Schools

Participant milestones

Participant milestones
Measure
Kids SipSmartER
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in sugar-sweetened beverage (SSB) role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
Control arm receives no intervention
Overall Study
STARTED
547 6
466 6
Overall Study
Student Started
357 6
308 6
Overall Study
Caregiver Started
190 6
158 6
Overall Study
Student Completed
329 6
258 6
Overall Study
Caregiver Completed
126 6
110 6
Overall Study
COMPLETED
455 6
368 6
Overall Study
NOT COMPLETED
92 0
98 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Total number includes Student and Caregiver participants numbers combined

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Kids SipSmartER
n=6 Schools
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=6 Schools
Control arm receives no intervention
Total
n=12 Schools
Total of all reporting groups
Age, Continuous
Student Age (years)
12.6 years
STANDARD_DEVIATION 0.5 • n=306 Participants • Total number includes Student and Caregiver participants numbers combined
12.7 years
STANDARD_DEVIATION 0.4 • n=220 Participants • Total number includes Student and Caregiver participants numbers combined
12.7 years
STANDARD_DEVIATION 0.5 • n=526 Participants • Total number includes Student and Caregiver participants numbers combined
Age, Continuous
Caregiver Age (years)
40.8 years
STANDARD_DEVIATION 7.0 • n=118 Participants • Total number includes Student and Caregiver participants numbers combined
40.4 years
STANDARD_DEVIATION 6.2 • n=102 Participants • Total number includes Student and Caregiver participants numbers combined
40.6 years
STANDARD_DEVIATION 6.7 • n=220 Participants • Total number includes Student and Caregiver participants numbers combined
Sex/Gender, Customized
Student Gender · Female
182 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
107 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
289 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
Sex/Gender, Customized
Student Gender · Male
122 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
109 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
231 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
Sex/Gender, Customized
Student Gender · Other or unknown
2 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
4 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
6 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
Sex/Gender, Customized
Caregiver Gender · Female
112 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
96 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
208 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
Sex/Gender, Customized
Caregiver Gender · Male
6 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
6 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
12 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
Sex/Gender, Customized
Caregiver Gender · Other or unknown
0 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
0 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
0 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
Ethnicity (NIH/OMB)
Student Ethnicity · Hispanic or Latino
15 Participants
n=306 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
9 Participants
n=220 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
24 Participants
n=526 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
Ethnicity (NIH/OMB)
Student Ethnicity · Not Hispanic or Latino
291 Participants
n=306 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
211 Participants
n=220 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
502 Participants
n=526 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
Ethnicity (NIH/OMB)
Student Ethnicity · Unknown or Not Reported
0 Participants
n=306 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
0 Participants
n=220 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
0 Participants
n=526 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
Ethnicity (NIH/OMB)
Caregiver Ethnicity · Hispanic or Latino
1 Participants
n=118 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
0 Participants
n=102 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
1 Participants
n=220 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
Ethnicity (NIH/OMB)
Caregiver Ethnicity · Not Hispanic or Latino
117 Participants
n=118 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
102 Participants
n=102 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
219 Participants
n=220 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
Ethnicity (NIH/OMB)
Caregiver Ethnicity · Unknown or Not Reported
0 Participants
n=118 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
0 Participants
n=102 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
0 Participants
n=220 Participants • Total number of participants includes the combination of student and caregiver participants within each arm of the study.
Race (NIH/OMB)
Student Race · American Indian or Alaska Native
42 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
32 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
74 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
Race (NIH/OMB)
Student Race · Asian
6 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
6 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
12 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
Race (NIH/OMB)
Student Race · Native Hawaiian or Other Pacific Islander
3 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
4 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
7 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
Race (NIH/OMB)
Student Race · Black or African American
9 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
10 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
19 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
Race (NIH/OMB)
Student Race · White
235 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
155 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
390 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
Race (NIH/OMB)
Student Race · More than one race
0 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
0 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
0 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
Race (NIH/OMB)
Student Race · Unknown or Not Reported
11 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
13 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
24 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
Race (NIH/OMB)
Caregiver Race · American Indian or Alaska Native
1 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
0 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
1 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
Race (NIH/OMB)
Caregiver Race · Asian
2 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
1 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
3 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
Race (NIH/OMB)
Caregiver Race · Native Hawaiian or Other Pacific Islander
0 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
1 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
1 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
Race (NIH/OMB)
Caregiver Race · Black or African American
3 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
4 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
7 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
Race (NIH/OMB)
Caregiver Race · White
105 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
88 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
193 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
Race (NIH/OMB)
Caregiver Race · More than one race
0 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
0 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
0 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
Race (NIH/OMB)
Caregiver Race · Unknown or Not Reported
7 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
8 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
15 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
Region of Enrollment
United States
424 participants
n=424 Participants
322 participants
n=322 Participants
746 participants
n=746 Participants
BMI status
Student BMI Status · Underweight (student BMI < 5th%; caregiver BMI < 18.5 kg/m2)
5 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
4 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
9 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
BMI status
Student BMI Status · Healthy Weight (student BMI 5th- <85th%; caregiver BMI 18.5-24.9 kg/m2)
142 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
103 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
245 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
BMI status
Student BMI Status · Overweight (student BMI 85th-<95th%; caregiver BMI 25-29.9 kg/m2)
57 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
39 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
96 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
BMI status
Student BMI Status · Obese (student BMI 95th -<99th%; caregiver BMI 30-34.9 kg/m2)
58 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
40 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
98 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
BMI status
Student BMI Status · Severe Obesity (student BMI >/= 99th%; caregiver BMI >/= 30 kg/m2)
33 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
15 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
48 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
BMI status
Student BMI Status · Other or unknown
11 Participants
n=306 Participants • Total number includes Student and Caregiver participants numbers combined
19 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
30 Participants
n=526 Participants • Total number includes Student and Caregiver participants numbers combined
BMI status
Caregiver BMI Status · Underweight (student BMI < 5th%; caregiver BMI < 18.5 kg/m2)
1 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
3 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
4 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
BMI status
Caregiver BMI Status · Healthy Weight (student BMI 5th- <85th%; caregiver BMI 18.5-24.9 kg/m2)
16 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
28 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
44 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
BMI status
Caregiver BMI Status · Overweight (student BMI 85th-<95th%; caregiver BMI 25-29.9 kg/m2)
31 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
27 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
58 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
BMI status
Caregiver BMI Status · Obese (student BMI 95th -<99th%; caregiver BMI 30-34.9 kg/m2)
26 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
16 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
42 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
BMI status
Caregiver BMI Status · Severe Obesity (student BMI >/= 99th%; caregiver BMI >/= 30 kg/m2)
34 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
21 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
55 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
BMI status
Caregiver BMI Status · Other or unknown
10 Participants
n=118 Participants • Total number includes Student and Caregiver participants numbers combined
7 Participants
n=102 Participants • Total number includes Student and Caregiver participants numbers combined
17 Participants
n=220 Participants • Total number includes Student and Caregiver participants numbers combined
Student BMI z-score
0.9 z-score
STANDARD_DEVIATION 1.1 • n=295 Participants • BMIz-scores are only calculated for the student sample. A total of 11 KSS student participants and 19 control student participants were not weighed and therefore are not in the sample.
1.0 z-score
STANDARD_DEVIATION 1.0 • n=201 Participants • BMIz-scores are only calculated for the student sample. A total of 11 KSS student participants and 19 control student participants were not weighed and therefore are not in the sample.
0.9 z-score
STANDARD_DEVIATION 1.1 • n=496 Participants • BMIz-scores are only calculated for the student sample. A total of 11 KSS student participants and 19 control student participants were not weighed and therefore are not in the sample.
Student BMI percentile
73.2 percentile
STANDARD_DEVIATION 27.1 • n=295 Participants • BMI percentiles are only calculated for the student sample. A total of 11 KSS student participants and 19 control student participants were not weighed and therefore are not in the sample.
75.8 percentile
STANDARD_DEVIATION 24.6 • n=201 Participants • BMI percentiles are only calculated for the student sample. A total of 11 KSS student participants and 19 control student participants were not weighed and therefore are not in the sample.
74.1 percentile
STANDARD_DEVIATION 26.2 • n=496 Participants • BMI percentiles are only calculated for the student sample. A total of 11 KSS student participants and 19 control student participants were not weighed and therefore are not in the sample.
Caregiver Educational Attainment
High School, GED, or less
28 Participants
n=118 Participants • Only caregivers are asked for their educational attainment.
28 Participants
n=102 Participants • Only caregivers are asked for their educational attainment.
56 Participants
n=220 Participants • Only caregivers are asked for their educational attainment.
Caregiver Educational Attainment
Some college, Associates degree
49 Participants
n=118 Participants • Only caregivers are asked for their educational attainment.
36 Participants
n=102 Participants • Only caregivers are asked for their educational attainment.
85 Participants
n=220 Participants • Only caregivers are asked for their educational attainment.
Caregiver Educational Attainment
4-year college degree or higher
36 Participants
n=118 Participants • Only caregivers are asked for their educational attainment.
35 Participants
n=102 Participants • Only caregivers are asked for their educational attainment.
71 Participants
n=220 Participants • Only caregivers are asked for their educational attainment.
Caregiver Educational Attainment
Other or unknown
5 Participants
n=118 Participants • Only caregivers are asked for their educational attainment.
3 Participants
n=102 Participants • Only caregivers are asked for their educational attainment.
8 Participants
n=220 Participants • Only caregivers are asked for their educational attainment.
Caregiver Household Income
<$25,000
20 Participants
n=118 Participants • Only caregivers are asked to report their family's annual household income
18 Participants
n=102 Participants • Only caregivers are asked to report their family's annual household income
38 Participants
n=220 Participants • Only caregivers are asked to report their family's annual household income
Caregiver Household Income
$25,000-$49,000
16 Participants
n=118 Participants • Only caregivers are asked to report their family's annual household income
20 Participants
n=102 Participants • Only caregivers are asked to report their family's annual household income
36 Participants
n=220 Participants • Only caregivers are asked to report their family's annual household income
Caregiver Household Income
$50,000-$74,999
25 Participants
n=118 Participants • Only caregivers are asked to report their family's annual household income
18 Participants
n=102 Participants • Only caregivers are asked to report their family's annual household income
43 Participants
n=220 Participants • Only caregivers are asked to report their family's annual household income
Caregiver Household Income
>/= $75,000
37 Participants
n=118 Participants • Only caregivers are asked to report their family's annual household income
31 Participants
n=102 Participants • Only caregivers are asked to report their family's annual household income
68 Participants
n=220 Participants • Only caregivers are asked to report their family's annual household income
Caregiver Household Income
Other or unknown
20 Participants
n=118 Participants • Only caregivers are asked to report their family's annual household income
15 Participants
n=102 Participants • Only caregivers are asked to report their family's annual household income
35 Participants
n=220 Participants • Only caregivers are asked to report their family's annual household income
Caregiver BMI
32.1 kg/m2
STANDARD_DEVIATION 7.7 • n=108 Participants • Only caregivers weight and height were calculated into a BMI. Additionally, a total of 10 KSS caregiver participants and 7 caregiver control participants did not report their weights and heights so BMI could not be calculated for them.
29.5 kg/m2
STANDARD_DEVIATION 8.0 • n=95 Participants • Only caregivers weight and height were calculated into a BMI. Additionally, a total of 10 KSS caregiver participants and 7 caregiver control participants did not report their weights and heights so BMI could not be calculated for them.
30.8 kg/m2
STANDARD_DEVIATION 7.9 • n=203 Participants • Only caregivers weight and height were calculated into a BMI. Additionally, a total of 10 KSS caregiver participants and 7 caregiver control participants did not report their weights and heights so BMI could not be calculated for them.

PRIMARY outcome

Timeframe: Baseline and 7-months

Population: This analysis only includes student participants. While caregivers were analyzed for change in SSB, caregiver SSB change was a secondary outcome and therefore they are not reported here. Overall participants analyzed includes students who completed both the baseline and 7 month follow up items for the BEVQ-15.

Change in ounces of sugar sweetened beverage consumption from Baseline to 7-months as measured via the validated Beverage Intake Questionnaire (BEVQ-15). Participants were asked to report how often and how much of the following sugary drinks they consumed in the past 30 days: regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks. Using standardized and validated scoring procedures, daily totals for each of the sugary beverages were determined by multiplying intake frequency by portion size. These daily total intakes were then summed across the five sugary drink types to obtain a total daily intake, in fluid ounces, of all sugary drinks. Change scores were calculated by subtracting the baseline sugary drink intake from the 7 month follow-up.

Outcome measures

Outcome measures
Measure
Kids SipSmartER
n=306 Participants
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=220 Participants
Control arm receives no intervention
Student: SSB Change From Baseline to 7-months (All Participants)
-9.9 fluid ounces
Interval -12.2 to -7.6
-2.7 fluid ounces
Interval -5.4 to -0.1

SECONDARY outcome

Timeframe: Baseline and 7-months

Population: This analysis only includes caregiver participants. While students were analyzed for change in SSB, student SSB change was a primary outcome and therefore they are not reported here. Overall participants analyzed includes caregivers who completed both the baseline and 7 month follow up items for the BEVQ-15.

Change in ounces of sugar sweetened beverage consumption from Baseline to 7-months as measured via the validated Beverage Intake Questionnaire (BEVQ-15). Participants were asked to report how often and how much of the following sugary drinks they consumed in the past 30 days: regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks. Using standardized and validated scoring procedures, daily totals for each of the sugary beverages were determined by multiplying intake frequency by portion size. These daily total intakes were then summed across the five sugary drink types to obtain a total daily intake, in fluid ounces, of all sugary drinks. Change scores were calculated by subtracting the baseline sugary drink intake from the 7 month follow-up.

Outcome measures

Outcome measures
Measure
Kids SipSmartER
n=118 Participants
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=102 Participants
Control arm receives no intervention
Caregiver: SSB Change From Baseline to 7-months (All Participants)
-8.2 fluid ounces
Interval -12.3 to -4.1
-6.3 fluid ounces
Interval -11.3 to -1.3

SECONDARY outcome

Timeframe: Baseline and 7-months

Population: Because BMI is calculated differently for adults, this analysis only includes student participants. Caregiver BMI changes are reported separately. Overall participants analyzed includes students who completed both the baseline and 7 month height and weight measures.

Student BMI z-score: BMI z-score was calculated using the World Health Organization (WHO) growth reference standards. The z-score represents the number of standard deviations a child's BMI is from the population mean for age and sex. A z-score of 0 corresponds to the median BMI of the reference population. Positive values indicate a BMI higher than the reference median, while negative values indicate a BMI lower than the reference median. Higher z-scores generally indicate increased adiposity, with standard clinical thresholds defining overweight as a BMI z-score ≥ 1 and obesity as a BMI z-score ≥ 2.

Outcome measures

Outcome measures
Measure
Kids SipSmartER
n=295 Participants
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=166 Participants
Control arm receives no intervention
Student: BMI Z-score Change From Baseline to 7-months
0.02 z-score
Interval -0.01 to 0.05
-0.018 z-score
Interval -0.09 to 0.06

SECONDARY outcome

Timeframe: Baseline and 7-months

Population: Because BMI is calculated differently for children, this analysis only includes caregiver participants. Student BMI changes are reported separately. Overall participants analyzed includes caregivers who reported their baseline and 7 month height and weight measures.

Caregiver BMI was calculated from height and weight data using the following equation: kg/m\^2

Outcome measures

Outcome measures
Measure
Kids SipSmartER
n=105 Participants
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=92 Participants
Control arm receives no intervention
Caregiver: BMI Change From Baseline to 7-Months
-0.3 kg/m^2
Interval -0.6 to -0.1
-0.65 kg/m^2
Interval -1.0 to -0.3

SECONDARY outcome

Timeframe: Baseline and 7-months

Population: Overall participants analyzed includes students and caregivers who completed both the baseline and 7 month overall health rating item.

Overall health rating is a Single item question asking to rate general overall health and scored on a 5-point Likert scale from 1=poor to 5=excellent.

Outcome measures

Outcome measures
Measure
Kids SipSmartER
n=422 Participants
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=311 Participants
Control arm receives no intervention
Student and Caregiver: Quality of Life Change From Baseline to 7-months--Overall Health Rating
Students: Overall Health Rating Change
0.06 units on a scale
Interval 0.003 to 0.1
0.03 units on a scale
Interval -0.1 to 0.2
Student and Caregiver: Quality of Life Change From Baseline to 7-months--Overall Health Rating
Caregivers: Overall Health Rating Change
0.04 units on a scale
Interval 0.0 to 0.1
-0.06 units on a scale
Interval -0.2 to 0.1

SECONDARY outcome

Timeframe: Baseline and 7-months

Population: Questions were only asked of caregiver and students are not included in the analysis. Overall participants analyzed includes caregivers who completed both the baseline and 7-month follow up items for the quality of life scale.

Using validated scoring procedures, an unhealthy days score was computed by adding the number of physically and mentally unhealthy days within the past 30 days, with a minimum score of 0 and maximum score of 30 days. Higher scores indicate worse quality of life.

Outcome measures

Outcome measures
Measure
Kids SipSmartER
n=109 Participants
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=93 Participants
Control arm receives no intervention
Caregiver: Quality of Life Change From Baseline to 7-months--Unhealthy Days
-0.3 units on a scale
Interval -1.1 to 0.6
-1.7 units on a scale
Interval -4.3 to 0.9

SECONDARY outcome

Timeframe: Baseline and 7-months

Population: This analysis only includes student participants. Caregiver quality of life measures are reported separately. Overall participants analyzed includes students who completed both the baseline and 7 month school related function items.

School-related quality of life (QOL) was assessed with the 5-item school functioning subscale of the Pediatric QOL Inventory which used a 5-point Likert scale (i.e., 1 = never a problem, 5 = almost always a problem). Applying validated scoring procedures, items were reverse-scored and linearly transformed to a 0 to 100 scale with higher scores indicating higher school-related QOL.

Outcome measures

Outcome measures
Measure
Kids SipSmartER
n=294 Participants
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=211 Participants
Control arm receives no intervention
Student: Quality of Life Change From Baseline to 7-months--school Related Function
-1.7 units on a scale
Interval -3.9 to 0.4
-3.9 units on a scale
Interval -7.0 to -0.07

POST_HOC outcome

Timeframe: Baseline and 7-months

Population: This analysis only includes caregiver participants who consumed \> 24 fluid ounces of SSB at Baseline AND who completed both the Baseline and 7 month SSB items for the BEVQ-15. While students were analyzed similarly, student SSB change across Baseline SSB intake was a primary outcome and therefore they are not reported here.

Change in ounces of sugar sweetened beverage consumption from Baseline to 7-months as measured via the validated Beverage Intake Questionnaire (BEVQ-15). Participants were asked to report how often and how much of the following sugary drinks they consumed in the past 30 days: regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks. Using standardized and validated scoring procedures, daily totals for each of the sugary beverages were determined by multiplying intake frequency by portion size. These daily total intakes were then summed across the five sugary drink types to obtain a total daily intake, in fluid ounces, of all sugary drinks. Change scores were calculated by subtracting the baseline sugary drink intake from the 7 month follow-up.

Outcome measures

Outcome measures
Measure
Kids SipSmartER
n=33 Participants
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=28 Participants
Control arm receives no intervention
Caregiver: SSB Change From Baseline to 7-months for Caregivers Consuming > 24 fl oz SSB at Baseline
-23.7 fluid ounces
Interval -29.7 to -17.7
-9.8 fluid ounces
Interval -13.6 to -6.1

POST_HOC outcome

Timeframe: Baseline and 7-months

Population: This analysis only includes caregiver participants who consumed \> 12 fluid ounces of SSB at Baseline AND who completed both the Baseline and 7 month SSB items for the BEVQ-15. While students were analyzed similarly, student SSB change across Baseline SSB intake was a primary outcome and therefore they are not reported here.

Change in ounces of sugar sweetened beverage consumption from Baseline to 7-months as measured via the validated Beverage Intake Questionnaire (BEVQ-15). Participants were asked to report how often and how much of the following sugary drinks they consumed in the past 30 days: regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks. Using standardized and validated scoring procedures, daily totals for each of the sugary beverages were determined by multiplying intake frequency by portion size. These daily total intakes were then summed across the five sugary drink types to obtain a total daily intake, in fluid ounces, of all sugary drinks. Change scores were calculated by subtracting the baseline sugary drink intake from the 7 month follow-up.

Outcome measures

Outcome measures
Measure
Kids SipSmartER
n=58 Participants
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=50 Participants
Control arm receives no intervention
Caregiver: SSB Change From Baseline to 7-months for Caregivers Consuming > 12 fl oz SSB at Baseline
-17.5 fluid ounces
Interval -20.8 to -14.2
-7.1 fluid ounces
Interval -9.1 to -5.1

POST_HOC outcome

Timeframe: Baseline and 7-months

Population: This analysis only includes caregiver participants who consumed \> 8 fluid ounces of SSB at Baseline AND who completed both the Baseline and 7 month SSB items for the BEVQ-15. While students were analyzed similarly, student SSB change across Baseline SSB intake was a primary outcome and therefore they are not reported here.

Change in ounces of sugar sweetened beverage consumption from Baseline to 7-months as measured via the validated Beverage Intake Questionnaire (BEVQ-15). Participants were asked to report how often and how much of the following sugary drinks they consumed in the past 30 days: regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks. Using standardized and validated scoring procedures, daily totals for each of the sugary beverages were determined by multiplying intake frequency by portion size. These daily total intakes were then summed across the five sugary drink types to obtain a total daily intake, in fluid ounces, of all sugary drinks. Change scores were calculated by subtracting the baseline sugary drink intake from the 7 month follow-up.

Outcome measures

Outcome measures
Measure
Kids SipSmartER
n=70 Participants
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=58 Participants
Control arm receives no intervention
Caregiver: SSB Change From Baseline to 7-months for Caregivers Consuming > 8 fl oz SSB at Baseline
-15.0 fluid ounces
Interval -18.6 to -11.5
-5.8 fluid ounces
Interval -7.2 to -4.5

POST_HOC outcome

Timeframe: Baseline and 7-months

Population: This analysis only includes student participants who consumed \> 24 fluid ounces of SSB at Baseline AND who completed both the Baseline and 7 month SSB items for the BEVQ-15. While caregivers were analyzed similarly, caregiver SSB change across Baseline SSB intake was a secondary outcome and therefore they are not reported here.

Change in ounces of sugar sweetened beverage consumption from Baseline to 7-months as measured via the validated Beverage Intake Questionnaire (BEVQ-15). Participants were asked to report how often and how much of the following sugary drinks they consumed in the past 30 days: regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks. Using standardized and validated scoring procedures, daily totals for each of the sugary beverages were determined by multiplying intake frequency by portion size. These daily total intakes were then summed across the five sugary drink types to obtain a total daily intake, in fluid ounces, of all sugary drinks. Change scores were calculated by subtracting the baseline sugary drink intake from the 7 month follow-up.

Outcome measures

Outcome measures
Measure
Kids SipSmartER
n=141 Participants
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=82 Participants
Control arm receives no intervention
Student: SSB Change From Baseline to 7-months for Students Consuming > 24 fl oz SSB at Baseline
-23.0 fluid ounces
Interval -27.0 to -19.0
-10.3 fluid ounces
Interval -17.7 to -2.9

POST_HOC outcome

Timeframe: Baseline and 7-months

Population: This analysis only includes student participants who consumed \> 12 fluid ounces of SSB at Baseline AND who completed both the Baseline and 7 month SSB items for the BEVQ-15. While caregivers were analyzed similarly, caregiver SSB change across Baseline SSB intake was a secondary outcome and therefore they are not reported here.

Change in ounces of sugar sweetened beverage consumption from Baseline to 7-months as measured via the validated Beverage Intake Questionnaire (BEVQ-15). Participants were asked to report how often and how much of the following sugary drinks they consumed in the past 30 days: regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks. Using standardized and validated scoring procedures, daily totals for each of the sugary beverages were determined by multiplying intake frequency by portion size. These daily total intakes were then summed across the five sugary drink types to obtain a total daily intake, in fluid ounces, of all sugary drinks. Change scores were calculated by subtracting the baseline sugary drink intake from the 7 month follow-up.

Outcome measures

Outcome measures
Measure
Kids SipSmartER
n=213 Participants
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=136 Participants
Control arm receives no intervention
Student: SSB Change From Baseline to 7-months for Students Consuming > 12 fl oz SSB at Baseline
-15.5 fluid ounces
Interval -19.0 to -12.0
-7.4 fluid ounces
Interval -11.2 to -3.7

POST_HOC outcome

Timeframe: Baseline and 7-months

Population: This analysis only includes student participants who consumed \> 8 fluid ounces of SSB at Baseline AND who completed both the Baseline and 7 month SSB items for the BEVQ-15. While caregivers were analyzed similarly, caregiver SSB change across Baseline SSB intake was a secondary outcome and therefore they are not reported here.

Change in ounces of sugar sweetened beverage consumption from Baseline to 7-months as measured via the validated Beverage Intake Questionnaire (BEVQ-15). Participants were asked to report how often and how much of the following sugary drinks they consumed in the past 30 days: regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks. Using standardized and validated scoring procedures, daily totals for each of the sugary beverages were determined by multiplying intake frequency by portion size. These daily total intakes were then summed across the five sugary drink types to obtain a total daily intake, in fluid ounces, of all sugary drinks. Change scores were calculated by subtracting the baseline sugary drink intake from the 7 month follow-up.

Outcome measures

Outcome measures
Measure
Kids SipSmartER
n=247 Participants
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes Kids SipSmartER: Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
Control
n=160 Participants
Control arm receives no intervention
Student: SSB Change From Baseline to 7-months for Students Consuming > 8 fl oz SSB at Baseline
-13.5 fluid ounces
Interval -16.2 to -10.8
-5.7 fluid ounces
Interval -8.5 to -2.9

Adverse Events

Kids SipSmartER

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

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. Jamie Zoellner

Univeristy of Virginia

Phone: 434-962-4488

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place