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Completed

NCT Number: NCT05159622

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Washington University

Washington D.C., District of Columbia, 20052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Water Up! at Home

Behavioral

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).

Primary outcomes

  1. Change in Sugary Drink Consumption for Parents

    Time frame: 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.

  2. Change in Water Consumption for Parents

    Time frame: 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 outcomes

  1. Parent-reported Water Consumption of Their Infant/Toddler

    Time frame: Up to 16 weeks from baseline

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

  2. Parent-reported Sugary Drink Consumption of Their Infant/Toddler

    Time frame: Baseline and up to 16 weeks after baseline

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

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

    Time frame: Baseline and up to 16 weeks after baseline

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

  4. Parent 100% Fruit Juice Consumption

    Time frame: From baseline up to 16 weeks

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

Other outcomes

  1. Body Mass Index for Parents

    Time frame: Baseline

    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.

  2. Waist Circumference for Parents

    Time frame: Baseline

    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).

  3. Hip Circumference for Parents

    Time frame: Baseline

    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).

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2021
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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