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

NCT ID: NCT05159622

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-07
• Study Completion Date: 2021-08-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Water Up! at Home

Intervention Type: 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).

Control

Participants will receive the standard educational curriculum from the home visiting program (and also a water filter as a token of appreciation).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Water 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Uriyoan Colon-Ramos

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

George Washington University

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

Countries

United States

References

Santillan-Vazquez C, Hernandez L, Reese AC, Burgos-Gil R, Cleary SD, Rivera IM, Gittelsohn J, Edberg MC, Monge-Rojas R, Colon-Ramos U. How providing a low-cost water filter pitcher led Latino parents to reduce sugar-sweetened beverages and increase their water intake: explanatory qualitative results from the Water Up!@Home intervention trial. Public Health Nutr. 2022 Nov;25(11):3195-3203. doi: 10.1017/S1368980022001744. Epub 2022 Aug 19.

Reference Type: DERIVED

PMID: 35983682 (View on PubMed)

Reese AC, Burgos-Gil R, Cleary SD, Lora K, Rivera I, Gittelsohn J, Seper S, Monge-Rojas R, Colon-Ramos U. Use of a Water Filter at Home Reduces Sugary Drink Consumption among Parents and Infants/Toddlers in a Predominantly Hispanic Community: Results from the Water Up!@ Home Intervention Trial. J Acad Nutr Diet. 2023 Jan;123(1):41-51. doi: 10.1016/j.jand.2022.06.006. Epub 2022 Jun 15.

Reference Type: DERIVED

PMID: 35714910 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5R21DK119749

Identifier Type: NIH

Identifier Source: secondary_id

View Link

051719

Identifier Type: -

Identifier Source: org_study_id