NCT05159622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2019

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 13, 2023

Completed
Last Updated

February 13, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

July 17, 2019

Results QC Date

August 9, 2022

Last Update Submit

January 26, 2023

Conditions

Keywords

nutritionsugar-sweetened beverageswater securitydietinfantstoddlers

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, post-treatment starting 12 weeks after start of intervention, and at most 16 weeks after start of intervention

  • Change in Water Consumption for Parents

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

    baseline, post-treatment starting 12 weeks after start of intervention and at most 16 weeks after start of intervention

Secondary Outcomes (4)

  • Parent-reported Water Consumption of Their Infant/Toddler

    Up to 16 weeks from baseline

  • Parent-reported Sugary Drink Consumption of Their Infant/Toddler

    Baseline and up to 16 weeks after baseline

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

    Baseline and up to 16 weeks after baseline

  • Parent 100% Fruit Juice Consumption

    From baseline up to 16 weeks

Other Outcomes (3)

  • Body Mass Index for Parents

    Baseline

  • Waist Circumference for Parents

    Baseline

  • Hip Circumference for Parents

    Baseline

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Water Up! at Home

Control

NO INTERVENTION

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

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University

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

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Uriyoan Colon-Ramos
Organization
George Washington University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data collector will not know if the participant received the intervention or control curriculum.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 17, 2019

First Posted

December 16, 2021

Study Start

May 7, 2019

Primary Completion

July 12, 2021

Study Completion

August 31, 2021

Last Updated

February 13, 2023

Results First Posted

February 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations