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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water Up! at Home
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring nutrition, sugar-sweetened beverages, water security, diet, infants, toddlers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • George Washington University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
Change in Water Consumption for Parents
Change in the amount of water consumed in oz/day from baseline

Secondary Outcome Measures

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.
Parent-reported Sugary Drink Consumption of Their Infant/Toddler
Parents were asked to report on their infant/toddlers' beverage consumption at baseline and endline.
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
Parent 100% Fruit Juice Consumption
Amount of 100% fruit juice consumed (ounces) per day.

Full Information

First Posted
July 17, 2019
Last Updated
January 26, 2023
Sponsor
George Washington University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05159622
Brief Title
Water Up@ At Home: An Intervention to Replace Sugary Drinks With Water
Official Title
Increasing Tap Water Drinking Behaviors Among Young Latino Children-(CentroNia)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
July 12, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
nutrition, sugar-sweetened beverages, water security, diet, infants, toddlers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Data collector will not know if the participant received the intervention or control curriculum.
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive the standard educational curriculum from the home visiting program (and also a water filter as a token of appreciation).
Intervention Type
Behavioral
Intervention Name(s)
Water Up! at Home
Intervention Description
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 Outcome Measure Information:
Title
Change in Sugary Drink Consumption for Parents
Description
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
Title
Change in Water Consumption for Parents
Description
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
Secondary Outcome Measure Information:
Title
Parent-reported Water Consumption of Their Infant/Toddler
Description
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
Title
Parent-reported Sugary Drink Consumption of Their Infant/Toddler
Description
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
Title
Parent-reported 100% Fruit Juice Consumption for Their Infant/Toddler
Description
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
Title
Parent 100% Fruit Juice Consumption
Description
Amount of 100% fruit juice consumed (ounces) per day.
Time Frame
From baseline up to 16 weeks
Other Pre-specified Outcome Measures:
Title
Body Mass Index for Parents
Description
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
Title
Waist Circumference for Parents
Description
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
Title
Hip Circumference for Parents
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35983682
Citation
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.
Results Reference
derived

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

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