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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21DK119749 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 16 weeks from baseline |
| Parent-reported Sugary Drink Consumption of Their Infant/Toddler |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index for Parents | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | 20052 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35983682 | Derived | 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. | |
| 35714910 | Derived |
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There were no significant events after participant enrollment. In terms of recruitment, 101 parents were originally recruited and completed a baseline survey but prior to assignment to groups, nine of those parents were deemed ineligible for the following reasons: the children of 6 parents aged out of the home visiting program; the children of 3 parents were younger than 6 months of age at time of recruitment and therefore not enrolled.
Adult parents (>18 yrs of age) of children aged 6 months to 3 yrs old who were enrolled in the home-visiting program of three Early Head Start centers in the Washington District of Columbia (DC) metropolitan area were eligible to participate in the study. After screening for eligibility criteria with the assistance of Early Head Start home visitors, a bilingual (Spanish/English) and trained data collector called eligible families to invite them to participate in the study and consent them.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Water Up!@Home | Participants received a BPA-free infusion water bottle, a child-size pitcher to be used for serving water, and a National Sanitation Foundation-certified 11-cup low-cost water filter pitcher and one additional filter cartridge. A 12-session curriculum delivered weekly by home visitors at home of participants included hands-on activities that emphasized observational learning, parent-child modeling of behaviors in beverage choice, and modeling behaviors to offer filtered tap water instead of juice or sugary drinks, and weekly goal setting to replace or dilute selected sugary drinks for themselves and their child. |
| FG001 | Comparison | During the same 12 weeks, comparison participants received the standard weekly educational curriculum from the home visiting program and the same low-cost water filter pitcher was provided as a token of appreciation). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Water UP!@Home | 12 week intervention and low-cost water filter pitcher |
| BG001 | Comparison | Standard educational curriculum from the home visiting program and also a water filter pitcher as a token of appreciation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Parents (adults> 18 yrs of age) who completed the intervention. | Posted | Median | Full Range | oz/day | Baseline, post-treatment starting 12 weeks after start of intervention, and at most 16 weeks after start of intervention |
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Serious and other adverse event data and all-cause mortality were not collected/monitored systematically. The research team met weekly or daily during data collection to review data quality, discuss and resolve any issues with data collection or reporting problems, and discuss any sensitivity or participant reactions to data collected and data collection procedures. Participants were all parents (adults > 18 yrs of age). Adverse events were also not monitored for children.
Serious and other [non-serious] adverse events were not collected or assessed as part of the study. The definition for adverse event/serious adverse event did not differ from clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Water Up!@Home | Serious and other [non-serious] adverse events were not collected or assessed as part of the study). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Uriyoan Colon-Ramos | George Washington University | 202994 1899 | uriyoan@gwu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2022 | Aug 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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Data collector will not know if the participant received the intervention or control curriculum.
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Parents were asked to report on their infant/toddlers' beverage consumption at baseline and endline. |
| 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 | Baseline and up to 16 weeks after baseline |
| Parent 100% Fruit Juice Consumption | Amount of 100% fruit juice consumed (ounces) per day. | From baseline up to 16 weeks |
| Baseline |
| Waist Circumference for Parents | 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). | Baseline |
| Hip Circumference for Parents | 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). | Baseline |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Language of preference: Spanish | Count of Participants | Participants |
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| Parent-reported sex of their child: female | Count of Participants | Participants |
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| Country of birth | Count of Participants | Participants |
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| OG001 | Comparison | During the same 12 weeks, comparison participants received the standard weekly educational curriculum from the home visiting program and the same low-cost water filter pitcher was provided as a token of appreciation). |
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| Primary | Change in Water Consumption for Parents | Change in the amount of water consumed in oz/day from baseline | Parent (adults > 18 yrs old) who completed baseline data collection, endline data collection. | Posted | Median | Full Range | oz/day | baseline, post-treatment starting 12 weeks after start of intervention and at most 16 weeks after start of intervention |
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| Secondary | 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. | Parents, who report on their infants/toddlers' beverage consumption | Posted | Median | Full Range | oz/day | Up to 16 weeks from baseline |
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| Secondary | Parent-reported Sugary Drink Consumption of Their Infant/Toddler | Parents were asked to report on their infant/toddlers' beverage consumption at baseline and endline. | Parents' report of their infant/toddler beverage consumption | Posted | Median | Full Range | oz/day | Baseline and up to 16 weeks after baseline |
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| Secondary | 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 | Parents who reported on their infant and toddler consumption of beverages | Posted | Median | Full Range | oz/day | Baseline and up to 16 weeks after baseline |
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| Secondary | Parent 100% Fruit Juice Consumption | Amount of 100% fruit juice consumed (ounces) per day. | Parents who completed the baseline and endline surveys. | Posted | Median | Full Range | oz/day | From baseline up to 16 weeks |
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| Other Pre-specified | Body Mass Index for Parents | 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. | Participants were adults (>18 yrs old) from cohort 1 (pre-pandemic) randomized to either intervention or comparison group. | Posted | Mean | Standard Deviation | kg/m(2) | Baseline |
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| Other Pre-specified | Waist Circumference for Parents | 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). | Adults (>18 yrs old) who completed baseline data collection. | Posted | Mean | Standard Deviation | cm | Baseline |
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| Other Pre-specified | Hip Circumference for Parents | 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). | Adult parents (>18 yrs old) who completed baseline data collection | Posted | Mean | Standard Deviation | cm | Baseline |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Comparison | Serious and other [non-serious] adverse events were not collected or assessed as part of the study). | 0 | 0 | 0 | 0 | 0 | 0 |
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| D004700 | Endocrine System Diseases |
| El Salvador |
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| Mexico |
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| Ethiopia |
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| Other |
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| Nicaragua |
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| Median fluid oz/day at endline |
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| Median water intake at endline (oz/day) infants/toddlers (parent reported) |
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| Endline- oz/day parent-report on sugary drink consumption of their infants/toddlers |
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| Endline |
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| Endline |
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