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Water Up@ At Home: An Intervention to Replace Sugary Drinks With Water

Increasing Tap Water Drinking Behaviors Among Young Latino Children-(CentroNia)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05159622
Enrollment
92
Registered
2021-12-16
Start date
2019-05-07
Completion date
2021-08-31
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

nutrition, sugar-sweetened beverages, water security, diet, infants, toddlers

Brief summary

This study will test the preliminary effects of an intervention to reduce sugary drinks among low-income parents (n=38)(primary caregivers) and their young children (6 months-3 year olds) compared to a control group (n=38). The main outcome is behavioral: sugary drink consumption (self-reported servings/day) among parents and among their children (parent-reported servings/day). These outcomes are measured at baseline and immediately after the 12-week intervention. An exploratory aim will test if the intervention has a sustained behavioral effect and an effect on body mass index and waist circumference of the parents 12 months after baseline. Our mixed methods multi-phase approach includes a quantitative component (randomized controlled trial - Aim 1) and a qualitative component (in-depth interviews and focus groups- Aim 2) to test the effects of a behavioral intervention to replace sugary drinks with water at home.

Detailed description

Consumption of sugar-sweetened beverages (SSB) is a risk factor for obesity, diabetes, and other chronic diseases. Consumption of SSB begins at an early age and may have cumulative detrimental consequences to health later in life. There is an urgent need to facilitate reduction of SSB consumption among young children before this behavior becomes part of an unhealthy lifestyle. The public health recommendation to drink water instead of SSB does not consider the multiple barriers that underserved communities face when choosing a beverage in an environment with limited access to clean, palatable drinking water, and saturated with SSB promotion. Using a community participatory approach, the investigators developed an intervention, Water Up! at Home, which draws on theory and community experience to position parents as social models for their young children. The objective of the current proposal is to test the preliminary effects of this intervention to replace SSB with filtered tap water among low-income parents and their children (6 months-3 year olds). The working hypothesis is that by addressing sociocultural (via curriculum) and physical (via water filter) barriers, parents can reduce their own and their children's SSB consumption. The investigators will use a multiphase sequential mixed-methods design to integrate qualitative and quantitative findings. Aim 1) Partnering with an existing home visiting program of Early Head Start (EHS), the EHS staff will deliver the intervention to replace SSB with filtered tap water at home and test its effects using a randomized control trial. H1) Parents randomly assigned to the Water Up! at Home program (n=38) will see a net reduction of 0.5 servings/day of SSB compared with the control group at the end of the intervention (12 weeks). H2) Findings will show a similar reduction in SSB consumption among young children. Exploratory aim: 12 months after baseline, the investigators will explore changes on body mass index and waist circumference of parents. To assess the quality of program implementation, the investigators will use a summative process evaluation. Aim 2) To assess the psychosocial mediators of intervention effects and to understand why the program was or was not successful, the investigators will conduct 30 in-depth interviews with parents, segmented by whether they responded positively/negatively to the intervention. The investigators will also conduct two focus groups with Early Head Start staff (n=10) to describe the aspects of the intervention design, context, implementation and delivery that may affect program impact, its sustainability and practicability. The study addresses a novel paradigm that posits water security at home as a determinant of SSB consumption among low-income parents and their children.

Interventions

BEHAVIORALWater Up! at Home

1: Addressing physical barriers to replace SSB with water at home: Participants will receive a personal, reusable bottle of water, a National Sanitation Foundation-certified water filter pitcher and one additional filter cartridge 2: Addressing sociocultural barriers to change individual perceptions: The curriculum has 6 topics delivered in 12 sessions: a) water for your health (diabetes/obesity among Latinos); b) health benefits of water vs. SSB, c) sugar content of SSB, d) safety & affordability of filtered tap water vs. bottled beverages, e) access and promotion of SSB vs. water in your community, f) tips for improving water taste, perceived susceptibility, severity, costs and benefits. 3: Addressing sociocultural barriers to increase skills: During each session, participants will be asked to perform hands-on learning activities (e.g., measure sugar content in SSB, take pictures of themselves explaining to their family members the key messages of various lessons).

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
George Washington University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Data collector will not know if the participant received the intervention or control curriculum.

Intervention model description

Effect Evaluation: Using a pre- and post-evaluation design, the investigators will evaluate the effects of randomized controlled trial by comparing self-reported SSB intake (servings/day) among participants in the intervention vs. control groups. Data collection points are: baseline, follow-up (12-weeks after the start of the intervention), and a second follow-up (12 months after the start of the intervention) to explore the sustainability of behaviors and potential effect on anthropometric measures. The entire survey (lasting about 40 minutes) will be administered at home. Primary Outcome (SSB intake) During the three data collection periods, the investigators will use the Beverage Intake Questionnaire a quantitative food frequency questionnaire that assesses habitual beverage consumption of 15 beverage categories in the past month.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adult (\>18 year old) primary caregivers (biological parents, legal guardians) with at least 1 child enrolled in the CentroNia home-visiting program. * No intention of moving from the neighborhood or moving out of the program for the next year

Exclusion criteria

* Caregivers with children younger than 6 months old at time of recruitment. * Caregivers who have access or be using a water filtration system including pitchers with filters or an installed filtering device.

Design outcomes

Primary

MeasureTime frameDescription
Change in Sugary Drink Consumption for ParentsBaseline, post-treatment starting 12 weeks after start of intervention, and at most 16 weeks after start of interventionAmount 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.
Change in Water Consumption for Parentsbaseline, post-treatment starting 12 weeks after start of intervention and at most 16 weeks after start of interventionChange in the amount of water consumed in oz/day from baseline

Secondary

MeasureTime frameDescription
Parent-reported Sugary Drink Consumption of Their Infant/ToddlerBaseline and up to 16 weeks after baselineParents were asked to report on their infant/toddlers' beverage consumption at baseline and endline.
Parent-reported Water Consumption of Their Infant/ToddlerUp to 16 weeks from baselineParents were asked to report on the water consumption of their infant/toddler at baseline and endline.
Parent-reported 100% Fruit Juice Consumption for Their Infant/ToddlerBaseline and up to 16 weeks after baselineParent-reported 100% fruit juice consumption for their infant/toddler at baseline and at endline
Parent 100% Fruit Juice ConsumptionFrom baseline up to 16 weeksAmount of 100% fruit juice consumed (ounces) per day.

Other

MeasureTime frameDescription
Waist Circumference for ParentsBaselineThis 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).
Body Mass Index for ParentsBaselineThese 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.
Hip Circumference for ParentsBaselineMeasured 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).

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
Intervention Water UP!@Home
12 week intervention and low-cost water filter pitcher
45
Comparison
Standard educational curriculum from the home visiting program and also a water filter pitcher as a token of appreciation.
47
Total92

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up45

Baseline characteristics

CharacteristicIntervention Water UP!@HomeComparisonTotal
Age, Continuous31.7 years
STANDARD_DEVIATION 6.8
32.3 years
STANDARD_DEVIATION 7
32.03 years
STANDARD_DEVIATION 7.33
Country of birth
El Salvador
4 Participants8 Participants12 Participants
Country of birth
Ethiopia
8 Participants4 Participants12 Participants
Country of birth
Guatemala
14 Participants18 Participants32 Participants
Country of birth
Mexico
1 Participants3 Participants4 Participants
Country of birth
Nicaragua
1 Participants2 Participants3 Participants
Country of birth
Other
3 Participants6 Participants9 Participants
Country of birth
United States
14 Participants6 Participants20 Participants
Language of preference: Spanish37 Participants40 Participants77 Participants
Parent-reported sex of their child: female26 Participants23 Participants49 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
45 Participants47 Participants92 Participants
Sex: Female, Male
Female
42 Participants45 Participants87 Participants
Sex: Female, Male
Male
3 Participants2 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Change in Sugary Drink Consumption for Parents

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.

Time frame: 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.

ArmMeasureGroupValue (MEDIAN)
Intervention Water Up!@HomeChange in Sugary Drink Consumption for ParentsBaseline oz/day median12 oz/day
Intervention Water Up!@HomeChange in Sugary Drink Consumption for ParentsEndline oz/day median4.57 oz/day
ComparisonChange in Sugary Drink Consumption for ParentsBaseline oz/day median14.29 oz/day
ComparisonChange in Sugary Drink Consumption for ParentsEndline oz/day median8.57 oz/day
p-value: 0.15t-test, 2 sided
Primary

Change in Water Consumption for Parents

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

Time frame: 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.

ArmMeasureGroupValue (MEDIAN)
Intervention Water Up!@HomeChange in Water Consumption for ParentsMedian fluid oz/day at baseline27 oz/day
Intervention Water Up!@HomeChange in Water Consumption for ParentsMedian fluid oz/day at endline38.14 oz/day
ComparisonChange in Water Consumption for ParentsMedian fluid oz/day at baseline48 oz/day
ComparisonChange in Water Consumption for ParentsMedian fluid oz/day at endline36.43 oz/day
p-value: 0.98t-test, 2 sided
Secondary

Parent 100% Fruit Juice Consumption

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

Time frame: From baseline up to 16 weeks

Population: Parents who completed the baseline and endline surveys.

ArmMeasureGroupValue (MEDIAN)
Intervention Water Up!@HomeParent 100% Fruit Juice ConsumptionBaseline2.86 oz/day
Intervention Water Up!@HomeParent 100% Fruit Juice ConsumptionEndline0 oz/day
ComparisonParent 100% Fruit Juice ConsumptionBaseline2.86 oz/day
ComparisonParent 100% Fruit Juice ConsumptionEndline2.86 oz/day
Secondary

Parent-reported 100% Fruit Juice Consumption for Their Infant/Toddler

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

Time frame: Baseline and up to 16 weeks after baseline

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

ArmMeasureGroupValue (MEDIAN)
Intervention Water Up!@HomeParent-reported 100% Fruit Juice Consumption for Their Infant/ToddlerBaseline0.71 oz/day
Intervention Water Up!@HomeParent-reported 100% Fruit Juice Consumption for Their Infant/ToddlerEndline0.71 oz/day
ComparisonParent-reported 100% Fruit Juice Consumption for Their Infant/ToddlerBaseline1.79 oz/day
ComparisonParent-reported 100% Fruit Juice Consumption for Their Infant/ToddlerEndline1.79 oz/day
p-value: 0.03t-test, 2 sided
Secondary

Parent-reported Sugary Drink Consumption of Their Infant/Toddler

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

Time frame: Baseline and up to 16 weeks after baseline

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

ArmMeasureGroupValue (MEDIAN)
Intervention Water Up!@HomeParent-reported Sugary Drink Consumption of Their Infant/ToddlerBaseline (oz/day) Parent-reported sugary drink consumption for infants/toddlers0 oz/day
Intervention Water Up!@HomeParent-reported Sugary Drink Consumption of Their Infant/ToddlerEndline- oz/day parent-report on sugary drink consumption of their infants/toddlers0 oz/day
ComparisonParent-reported Sugary Drink Consumption of Their Infant/ToddlerBaseline (oz/day) Parent-reported sugary drink consumption for infants/toddlers0.29 oz/day
ComparisonParent-reported Sugary Drink Consumption of Their Infant/ToddlerEndline- oz/day parent-report on sugary drink consumption of their infants/toddlers0.14 oz/day
p-value: 0.92t-test, 2 sided
Secondary

Parent-reported Water Consumption of Their Infant/Toddler

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

Time frame: Up to 16 weeks from baseline

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

ArmMeasureGroupValue (MEDIAN)
Intervention Water Up!@HomeParent-reported Water Consumption of Their Infant/ToddlerMedian water intake at baseline (oz/day) infants/toddlers (parent reported)6 oz/day
Intervention Water Up!@HomeParent-reported Water Consumption of Their Infant/ToddlerMedian water intake at endline (oz/day) infants/toddlers (parent reported)8 oz/day
ComparisonParent-reported Water Consumption of Their Infant/ToddlerMedian water intake at baseline (oz/day) infants/toddlers (parent reported)6 oz/day
ComparisonParent-reported Water Consumption of Their Infant/ToddlerMedian water intake at endline (oz/day) infants/toddlers (parent reported)7.36 oz/day
p-value: 0.36t-test, 2 sided
Other Pre-specified

Body Mass Index for Parents

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.

Time frame: Baseline

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

ArmMeasureValue (MEAN)Dispersion
Intervention Water Up!@HomeBody Mass Index for Parents29.4 kg/m(2)Standard Deviation 6.1
ComparisonBody Mass Index for Parents29.6 kg/m(2)Standard Deviation 6.5
Other Pre-specified

Hip Circumference for Parents

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).

Time frame: Baseline

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

ArmMeasureValue (MEAN)Dispersion
Intervention Water Up!@HomeHip Circumference for Parents108.2 cmStandard Deviation 11.4
ComparisonHip Circumference for Parents106.2 cmStandard Deviation 13.7
Other Pre-specified

Waist Circumference for Parents

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).

Time frame: Baseline

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

ArmMeasureValue (MEAN)Dispersion
Intervention Water Up!@HomeWaist Circumference for Parents88.1 cmStandard Deviation 12.3
ComparisonWaist Circumference for Parents89.8 cmStandard Deviation 12.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026