Trial Outcomes & Findings for Water Up@ At Home: An Intervention to Replace Sugary Drinks With Water (NCT NCT05159622)

Results Overview

Amount of sugary drinks consumed (ounces) per day. Sugar-sweetened beverages was a composite variable created from the sum of sweetened fruit drink, soda, flavored milk, sweetened coffee/tea, and sports or energy drinks.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

92 participants

Primary outcome timeframe

Baseline, post-treatment starting 12 weeks after start of intervention, and at most 16 weeks after start of intervention

Results posted on

2023-02-13

Participant Flow

Adult parents (\>18 yrs of age) of children aged 6 months to 3 yrs old who were enrolled in the home-visiting program of three Early Head Start centers in the Washington District of Columbia (DC) metropolitan area were eligible to participate in the study. After screening for eligibility criteria with the assistance of Early Head Start home visitors, a bilingual (Spanish/English) and trained data collector called eligible families to invite them to participate in the study and consent them.

There were no significant events after participant enrollment. In terms of recruitment, 101 parents were originally recruited and completed a baseline survey but prior to assignment to groups, nine of those parents were deemed ineligible for the following reasons: the children of 6 parents aged out of the home visiting program; the children of 3 parents were younger than 6 months of age at time of recruitment and therefore not enrolled.

Participant milestones

Participant milestones
Measure	Intervention Water Up!@Home Participants received a BPA-free infusion water bottle, a child-size pitcher to be used for serving water, and a National Sanitation Foundation-certified 11-cup low-cost water filter pitcher and one additional filter cartridge. A 12-session curriculum delivered weekly by home visitors at home of participants included hands-on activities that emphasized observational learning, parent-child modeling of behaviors in beverage choice, and modeling behaviors to offer filtered tap water instead of juice or sugary drinks, and weekly goal setting to replace or dilute selected sugary drinks for themselves and their child.	Comparison During the same 12 weeks, comparison participants received the standard weekly educational curriculum from the home visiting program and the same low-cost water filter pitcher was provided as a token of appreciation).
Overall Study STARTED	45	47
Overall Study COMPLETED	41	42
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Water Up!@Home Participants received a BPA-free infusion water bottle, a child-size pitcher to be used for serving water, and a National Sanitation Foundation-certified 11-cup low-cost water filter pitcher and one additional filter cartridge. A 12-session curriculum delivered weekly by home visitors at home of participants included hands-on activities that emphasized observational learning, parent-child modeling of behaviors in beverage choice, and modeling behaviors to offer filtered tap water instead of juice or sugary drinks, and weekly goal setting to replace or dilute selected sugary drinks for themselves and their child.	Comparison During the same 12 weeks, comparison participants received the standard weekly educational curriculum from the home visiting program and the same low-cost water filter pitcher was provided as a token of appreciation).
Overall Study Lost to Follow-up	4	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Water UP!@Home n=45 Participants 12 week intervention and low-cost water filter pitcher	Comparison n=47 Participants Standard educational curriculum from the home visiting program and also a water filter pitcher as a token of appreciation.	Total n=92 Participants Total of all reporting groups
Age, Continuous	31.7 years STANDARD_DEVIATION 6.8 • n=45 Participants	32.3 years STANDARD_DEVIATION 7 • n=47 Participants	32.03 years STANDARD_DEVIATION 7.33 • n=92 Participants
Sex: Female, Male Female	42 Participants n=45 Participants	45 Participants n=47 Participants	87 Participants n=92 Participants
Sex: Female, Male Male	3 Participants n=45 Participants	2 Participants n=47 Participants	5 Participants n=92 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	45 Participants n=45 Participants	47 Participants n=47 Participants	92 Participants n=92 Participants
Language of preference: Spanish	37 Participants n=45 Participants	40 Participants n=47 Participants	77 Participants n=92 Participants
Parent-reported sex of their child: female	26 Participants n=45 Participants	23 Participants n=47 Participants	49 Participants n=92 Participants
Country of birth United States	14 Participants n=45 Participants	6 Participants n=47 Participants	20 Participants n=92 Participants
Country of birth Guatemala	14 Participants n=45 Participants	18 Participants n=47 Participants	32 Participants n=92 Participants
Country of birth El Salvador	4 Participants n=45 Participants	8 Participants n=47 Participants	12 Participants n=92 Participants
Country of birth Mexico	1 Participants n=45 Participants	3 Participants n=47 Participants	4 Participants n=92 Participants
Country of birth Ethiopia	8 Participants n=45 Participants	4 Participants n=47 Participants	12 Participants n=92 Participants
Country of birth Other	3 Participants n=45 Participants	6 Participants n=47 Participants	9 Participants n=92 Participants
Country of birth Nicaragua	1 Participants n=45 Participants	2 Participants n=47 Participants	3 Participants n=92 Participants

PRIMARY outcome

Timeframe: Baseline, post-treatment starting 12 weeks after start of intervention, and at most 16 weeks after start of intervention

Population: Parents (adults\> 18 yrs of age) who completed the intervention.

Amount of sugary drinks consumed (ounces) per day. Sugar-sweetened beverages was a composite variable created from the sum of sweetened fruit drink, soda, flavored milk, sweetened coffee/tea, and sports or energy drinks.

Outcome measures

Outcome measures
Measure	Intervention Water Up!@Home n=45 Participants The intervention was informed by formative research, and combined elements of the Social Cognitive Theory and the Health Belief Model to address both physical (perceptions of tap water quality and safety) and sociocultural barriers to replacing sugary drinks and excess juice consumption with water, primarily from tap. Participants received a BPA-free infusion water bottle, a child-size pitcher to be used for serving water, and a National Sanitation Foundation-certified 11-cup low-cost water filter pitcher and one additional filter cartridge. A 12-session curriculum delivered weekly by home visitors at home of participants included hands-on activities that emphasized observational learning, parent-child modeling of behaviors in beverage choice, and modeling behaviors to offer filtered tap water instead of juice or sugary drinks, and weekly goal setting to replace or dilute selected sugary drinks for themselves and their child. Home visits conducted in 10-35 min of the 90 min Early Head Start standard home visit.	Comparison n=47 Participants During the same 12 weeks, comparison participants received the standard weekly educational curriculum from the home visiting program and the same low-cost water filter pitcher was provided as a token of appreciation).
Change in Sugary Drink Consumption for Parents Baseline oz/day median	12 oz/day Interval 0.0 to 96.0	14.29 oz/day Interval 0.0 to 88.0
Change in Sugary Drink Consumption for Parents Endline oz/day median	4.57 oz/day Interval 0.0 to 53.5	8.57 oz/day Interval 0.0 to 48.28

PRIMARY outcome

Timeframe: baseline, post-treatment starting 12 weeks after start of intervention and at most 16 weeks after start of intervention

Population: Parent (adults \> 18 yrs old) who completed baseline data collection, endline data collection.

Change in the amount of water consumed in oz/day from baseline

Outcome measures

Outcome measures
Measure	Intervention Water Up!@Home n=45 Participants The intervention was informed by formative research, and combined elements of the Social Cognitive Theory and the Health Belief Model to address both physical (perceptions of tap water quality and safety) and sociocultural barriers to replacing sugary drinks and excess juice consumption with water, primarily from tap. Participants received a BPA-free infusion water bottle, a child-size pitcher to be used for serving water, and a National Sanitation Foundation-certified 11-cup low-cost water filter pitcher and one additional filter cartridge. A 12-session curriculum delivered weekly by home visitors at home of participants included hands-on activities that emphasized observational learning, parent-child modeling of behaviors in beverage choice, and modeling behaviors to offer filtered tap water instead of juice or sugary drinks, and weekly goal setting to replace or dilute selected sugary drinks for themselves and their child. Home visits conducted in 10-35 min of the 90 min Early Head Start standard home visit.	Comparison n=47 Participants During the same 12 weeks, comparison participants received the standard weekly educational curriculum from the home visiting program and the same low-cost water filter pitcher was provided as a token of appreciation).
Change in Water Consumption for Parents Median fluid oz/day at baseline	27 oz/day Interval 6.0 to 87.0	48 oz/day Interval 0.86 to 60.0
Change in Water Consumption for Parents Median fluid oz/day at endline	38.14 oz/day Interval 14.9 to 85.7	36.43 oz/day Interval 18.0 to 108.0

SECONDARY outcome

Timeframe: Up to 16 weeks from baseline

Population: Parents, who report on their infants/toddlers' beverage consumption

Parents were asked to report on the water consumption of their infant/toddler at baseline and endline.

Outcome measures

Outcome measures
Measure	Intervention Water Up!@Home n=45 Participants The intervention was informed by formative research, and combined elements of the Social Cognitive Theory and the Health Belief Model to address both physical (perceptions of tap water quality and safety) and sociocultural barriers to replacing sugary drinks and excess juice consumption with water, primarily from tap. Participants received a BPA-free infusion water bottle, a child-size pitcher to be used for serving water, and a National Sanitation Foundation-certified 11-cup low-cost water filter pitcher and one additional filter cartridge. A 12-session curriculum delivered weekly by home visitors at home of participants included hands-on activities that emphasized observational learning, parent-child modeling of behaviors in beverage choice, and modeling behaviors to offer filtered tap water instead of juice or sugary drinks, and weekly goal setting to replace or dilute selected sugary drinks for themselves and their child. Home visits conducted in 10-35 min of the 90 min Early Head Start standard home visit.	Comparison n=47 Participants During the same 12 weeks, comparison participants received the standard weekly educational curriculum from the home visiting program and the same low-cost water filter pitcher was provided as a token of appreciation).
Parent-reported Water Consumption of Their Infant/Toddler Median water intake at baseline (oz/day) infants/toddlers (parent reported)	6 oz/day Interval 0.0 to 36.0	6 oz/day Interval 0.0 to 19.0
Parent-reported Water Consumption of Their Infant/Toddler Median water intake at endline (oz/day) infants/toddlers (parent reported)	8 oz/day Interval 1.43 to 37.5	7.36 oz/day Interval 1.43 to 30.0

SECONDARY outcome

Timeframe: Baseline and up to 16 weeks after baseline

Population: Parents' report of their infant/toddler beverage consumption

Parents were asked to report on their infant/toddlers' beverage consumption at baseline and endline.

Outcome measures

Outcome measures
Measure	Intervention Water Up!@Home n=45 Participants The intervention was informed by formative research, and combined elements of the Social Cognitive Theory and the Health Belief Model to address both physical (perceptions of tap water quality and safety) and sociocultural barriers to replacing sugary drinks and excess juice consumption with water, primarily from tap. Participants received a BPA-free infusion water bottle, a child-size pitcher to be used for serving water, and a National Sanitation Foundation-certified 11-cup low-cost water filter pitcher and one additional filter cartridge. A 12-session curriculum delivered weekly by home visitors at home of participants included hands-on activities that emphasized observational learning, parent-child modeling of behaviors in beverage choice, and modeling behaviors to offer filtered tap water instead of juice or sugary drinks, and weekly goal setting to replace or dilute selected sugary drinks for themselves and their child. Home visits conducted in 10-35 min of the 90 min Early Head Start standard home visit.	Comparison n=47 Participants During the same 12 weeks, comparison participants received the standard weekly educational curriculum from the home visiting program and the same low-cost water filter pitcher was provided as a token of appreciation).
Parent-reported Sugary Drink Consumption of Their Infant/Toddler Baseline (oz/day) Parent-reported sugary drink consumption for infants/toddlers	0 oz/day Interval 0.0 to 28.5	0.29 oz/day Interval 0.0 to 25.72
Parent-reported Sugary Drink Consumption of Their Infant/Toddler Endline- oz/day parent-report on sugary drink consumption of their infants/toddlers	0 oz/day Interval 0.0 to 22.5	0.14 oz/day Interval 0.0 to 20.0

SECONDARY outcome

Timeframe: Baseline and up to 16 weeks after baseline

Population: Parents who reported on their infant and toddler consumption of beverages

Parent-reported 100% fruit juice consumption for their infant/toddler at baseline and at endline

Outcome measures

Outcome measures
Measure	Intervention Water Up!@Home n=45 Participants The intervention was informed by formative research, and combined elements of the Social Cognitive Theory and the Health Belief Model to address both physical (perceptions of tap water quality and safety) and sociocultural barriers to replacing sugary drinks and excess juice consumption with water, primarily from tap. Participants received a BPA-free infusion water bottle, a child-size pitcher to be used for serving water, and a National Sanitation Foundation-certified 11-cup low-cost water filter pitcher and one additional filter cartridge. A 12-session curriculum delivered weekly by home visitors at home of participants included hands-on activities that emphasized observational learning, parent-child modeling of behaviors in beverage choice, and modeling behaviors to offer filtered tap water instead of juice or sugary drinks, and weekly goal setting to replace or dilute selected sugary drinks for themselves and their child. Home visits conducted in 10-35 min of the 90 min Early Head Start standard home visit.	Comparison n=47 Participants During the same 12 weeks, comparison participants received the standard weekly educational curriculum from the home visiting program and the same low-cost water filter pitcher was provided as a token of appreciation).
Parent-reported 100% Fruit Juice Consumption for Their Infant/Toddler Baseline	0.71 oz/day Interval 0.0 to 15.0	1.79 oz/day Interval 0.0 to 15.0
Parent-reported 100% Fruit Juice Consumption for Their Infant/Toddler Endline	0.71 oz/day Interval 0.0 to 7.5	1.79 oz/day Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: From baseline up to 16 weeks

Population: Parents who completed the baseline and endline surveys.

Amount of 100% fruit juice consumed (ounces) per day.

Outcome measures

Outcome measures
Measure	Intervention Water Up!@Home n=45 Participants The intervention was informed by formative research, and combined elements of the Social Cognitive Theory and the Health Belief Model to address both physical (perceptions of tap water quality and safety) and sociocultural barriers to replacing sugary drinks and excess juice consumption with water, primarily from tap. Participants received a BPA-free infusion water bottle, a child-size pitcher to be used for serving water, and a National Sanitation Foundation-certified 11-cup low-cost water filter pitcher and one additional filter cartridge. A 12-session curriculum delivered weekly by home visitors at home of participants included hands-on activities that emphasized observational learning, parent-child modeling of behaviors in beverage choice, and modeling behaviors to offer filtered tap water instead of juice or sugary drinks, and weekly goal setting to replace or dilute selected sugary drinks for themselves and their child. Home visits conducted in 10-35 min of the 90 min Early Head Start standard home visit.	Comparison n=47 Participants During the same 12 weeks, comparison participants received the standard weekly educational curriculum from the home visiting program and the same low-cost water filter pitcher was provided as a token of appreciation).
Parent 100% Fruit Juice Consumption Baseline	2.86 oz/day Interval 0.0 to 24.0	2.86 oz/day Interval 0.0 to 36.0
Parent 100% Fruit Juice Consumption Endline	0 oz/day Interval 0.0 to 12.0	2.86 oz/day Interval 0.0 to 16.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Participants were adults (\>18 yrs old) from cohort 1 (pre-pandemic) randomized to either intervention or comparison group.

These measures were only collected at baseline, due to challenges from the onset of the COVID-19 pandemic. At baseline, body weight and body height were measured twice from parents who were barefoot and wearing light clothing, standing on the center of the scale and in a vertical position, using a scale with precision of 100g, and a stadiometer (for weight). Body mass index was calculated from kg/m\^2.

Outcome measures

Outcome measures
Measure	Intervention Water Up!@Home n=31 Participants The intervention was informed by formative research, and combined elements of the Social Cognitive Theory and the Health Belief Model to address both physical (perceptions of tap water quality and safety) and sociocultural barriers to replacing sugary drinks and excess juice consumption with water, primarily from tap. Participants received a BPA-free infusion water bottle, a child-size pitcher to be used for serving water, and a National Sanitation Foundation-certified 11-cup low-cost water filter pitcher and one additional filter cartridge. A 12-session curriculum delivered weekly by home visitors at home of participants included hands-on activities that emphasized observational learning, parent-child modeling of behaviors in beverage choice, and modeling behaviors to offer filtered tap water instead of juice or sugary drinks, and weekly goal setting to replace or dilute selected sugary drinks for themselves and their child. Home visits conducted in 10-35 min of the 90 min Early Head Start standard home visit.	Comparison n=33 Participants During the same 12 weeks, comparison participants received the standard weekly educational curriculum from the home visiting program and the same low-cost water filter pitcher was provided as a token of appreciation).
Body Mass Index for Parents	29.4 kg/m(2) Standard Deviation 6.1	29.6 kg/m(2) Standard Deviation 6.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Adults (\>18 yrs old) who completed baseline data collection.

This was only collected at baseline from some participants due to the onset of COVID-19. At baseline Measured from parents in a standing position, at midpoint between the lower border of the last rib and the upper border of the iliac crest on the horizontal place, using an inextensible Gulick measuring tape graduated in cm. Data collectors took 3 waist circumference measurements (the average was used for analyses).

Outcome measures

Outcome measures
Measure	Intervention Water Up!@Home n=31 Participants The intervention was informed by formative research, and combined elements of the Social Cognitive Theory and the Health Belief Model to address both physical (perceptions of tap water quality and safety) and sociocultural barriers to replacing sugary drinks and excess juice consumption with water, primarily from tap. Participants received a BPA-free infusion water bottle, a child-size pitcher to be used for serving water, and a National Sanitation Foundation-certified 11-cup low-cost water filter pitcher and one additional filter cartridge. A 12-session curriculum delivered weekly by home visitors at home of participants included hands-on activities that emphasized observational learning, parent-child modeling of behaviors in beverage choice, and modeling behaviors to offer filtered tap water instead of juice or sugary drinks, and weekly goal setting to replace or dilute selected sugary drinks for themselves and their child. Home visits conducted in 10-35 min of the 90 min Early Head Start standard home visit.	Comparison n=33 Participants During the same 12 weeks, comparison participants received the standard weekly educational curriculum from the home visiting program and the same low-cost water filter pitcher was provided as a token of appreciation).
Waist Circumference for Parents	88.1 cm Standard Deviation 12.3	89.8 cm Standard Deviation 12.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Adult parents (\>18 yrs old) who completed baseline data collection

Measured from parents in a standing position, at midpoint on the widest part of the hips, horizontal place, using an inextensible Gulick measuring tape graduated in cm. Data collectors took 3 hip circumference measurements (the average was used for analyses).

Outcome measures

Outcome measures
Measure	Intervention Water Up!@Home n=31 Participants The intervention was informed by formative research, and combined elements of the Social Cognitive Theory and the Health Belief Model to address both physical (perceptions of tap water quality and safety) and sociocultural barriers to replacing sugary drinks and excess juice consumption with water, primarily from tap. Participants received a BPA-free infusion water bottle, a child-size pitcher to be used for serving water, and a National Sanitation Foundation-certified 11-cup low-cost water filter pitcher and one additional filter cartridge. A 12-session curriculum delivered weekly by home visitors at home of participants included hands-on activities that emphasized observational learning, parent-child modeling of behaviors in beverage choice, and modeling behaviors to offer filtered tap water instead of juice or sugary drinks, and weekly goal setting to replace or dilute selected sugary drinks for themselves and their child. Home visits conducted in 10-35 min of the 90 min Early Head Start standard home visit.	Comparison n=33 Participants During the same 12 weeks, comparison participants received the standard weekly educational curriculum from the home visiting program and the same low-cost water filter pitcher was provided as a token of appreciation).
Hip Circumference for Parents	108.2 cm Standard Deviation 11.4	106.2 cm Standard Deviation 13.7

Adverse Events

Intervention Water Up!@Home

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparison

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

Uriyoan Colon-Ramos

George Washington University

Phone: 202994 1899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place