Diabetes Mellitus, Type 2NCT05159622
Water Up@ At Home: An Intervention to Replace Sugary Drinks With Water
A study testing Water Up! at Home in people with Diabetes Mellitus, Type 2, run by George Washington University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Water Up! at Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: Increasing Tap Water Drinking Behaviors Among Young Latino Children-(CentroNia)
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.
Read the 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
- Being tested
- Water Up! at Home
- Keywords
- nutrition, sugar-sweetened beverages, water security, diet, infants, toddlers
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water Up! at HomeBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Parents were asked to report on the water consumption of their infant/toddler at baseline and endline.
Measured: Up to 16 weeks from baseline
Parent-reported Sugary Drink Consumption of Their Infant/Toddler
Parents were asked to report on their infant/toddlers' beverage consumption at baseline and endline.
Measured: Baseline and up to 16 weeks after baseline
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
Measured: Baseline and up to 16 weeks after baseline
Parent 100% Fruit Juice Consumption
Amount of 100% fruit juice consumed (ounces) per day.
Measured: From baseline up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start7 May 2019
- Primary completion12 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uriyoan Colon-Ramos, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159622
- Sponsor's protocol ID
- 051719
- Other IDs
- 5R21DK119749
- Status last verified
- Jan 2023
- First submitted
- 17 Jul 2019
- Last updated
- 13 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35983682Reese 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.
PubMed 35714910
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Tap Water Drinking Behaviors Among Young Latino Children-(CentroNia)
- ClinicalTrials.gov ID
- NCT05159622
- Acronym / sponsor ID
- 051719
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- nutrition, sugar-sweetened beverages, water security, diet, infants, toddlers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 May 2019 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Posted 13 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Water Up! at HomeDescription 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water Up! at Home1: 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). | Behavioural | Intervention |
Primary outcome
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.
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
4 secondary outcomes
Parent-reported Water Consumption of Their Infant/Toddler
Time frame: Up to 16 weeks from baseline
Parent-reported Sugary Drink Consumption of Their Infant/Toddler
Time frame: Baseline and up to 16 weeks after baseline
Parent-reported 100% Fruit Juice Consumption for Their Infant/Toddler
Time frame: Baseline and up to 16 weeks after baseline
Parent 100% Fruit Juice Consumption
Time frame: From baseline up to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35983682Santillan-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.
- Derived from this study: PubMed 35714910Reese 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Up! at Home in people with Diabetes Mellitus, Type 2, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05159622, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.