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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Water Up! at Home

• Registration Number: NCT05159622
• Lead Sponsor: George Washington University

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.

Study Timeline

• Study Start: 2019-05-07
• Study First Submitted: 2019-07-17
• Primary Completion: 2021-07-12
• Study Completion: 2021-08-31
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-16
• Results First Submitted: 2022-08-09
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-26
• Last Update Submitted: 2023-01-26
• Results First Posted: 2023-02-13
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Water Up! at Home	Description of behavioral intervention Water Up! at Home: The intervention is theory-based and was designed to be sensitive to the context, perceptions and needs of this high risk population. It was collaboratively developed with key stakeholders in the predominantly Latino immigrant community. The curriculum consists of 12 infographics and lessons (bilingual Spanish/English) designed to increase knowledge of drinking water health benefits, safety/cleanliness, cost/convenience, prior experience. The 12-week intervention will be delivered in participants' home by the home visitor. Participants will receive a water filter for use in their home in addition to educational information about water and sugary beverages. Throughout the lessons, they will be asked to complete various activities such as taking pictures and engaging in discussions about their water drinking habits.

Primary Outcome Measures

Name	Time	Method
Change in Sugary Drink Consumption for Parents	Baseline, post-treatment starting 12 weeks after start of intervention, and at most 16 weeks after start of 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.
Change in Water Consumption for Parents	baseline, post-treatment starting 12 weeks after start of intervention and at most 16 weeks after start of intervention	Change in the amount of water consumed in oz/day from baseline

Secondary Outcome Measures

Name	Time	Method
Parent-reported Water Consumption of Their Infant/Toddler	Up to 16 weeks from baseline	Parents 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/Toddler	Baseline and up to 16 weeks after baseline	Parent-reported 100% fruit juice consumption for their infant/toddler at baseline and at endline
Parent 100% Fruit Juice Consumption	From baseline up to 16 weeks	Amount of 100% fruit juice consumed (ounces) per day.
Parent-reported Sugary Drink Consumption of Their Infant/Toddler	Baseline and up to 16 weeks after baseline	Parents were asked to report on their infant/toddlers' beverage consumption at baseline and endline.

Trial Locations

Locations (1)

George Washington University; 🇺🇸 Washington, District of Columbia, United States