Diabetes Mellitus, Type 2
Conditions
Keywords
nutrition, sugar-sweetened beverages, water security, diet, infants, toddlers
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.
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).
Sponsors
Study design
Masking description
Data collector will not know if the participant received the intervention or control curriculum.
Intervention 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.
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sugary Drink Consumption for Parents | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent-reported Sugary Drink Consumption of Their Infant/Toddler | Baseline and up to 16 weeks after baseline | Parents were asked to report on their infant/toddlers' beverage consumption at baseline and endline. |
| Parent-reported Water Consumption of Their Infant/Toddler | Up to 16 weeks from baseline | Parents were asked to report on the water consumption of their infant/toddler at baseline and endline. |
| Parent-reported 100% Fruit Juice Consumption for Their Infant/Toddler | Baseline and up to 16 weeks after baseline | Parent-reported 100% fruit juice consumption for their infant/toddler at baseline and at endline |
| Parent 100% Fruit Juice Consumption | From baseline up to 16 weeks | Amount of 100% fruit juice consumed (ounces) per day. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference for Parents | Baseline | 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). |
| Body Mass Index for Parents | Baseline | 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. |
| Hip Circumference for Parents | Baseline | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Water UP!@Home 12 week intervention and low-cost water filter pitcher | 45 |
| Comparison Standard educational curriculum from the home visiting program and also a water filter pitcher as a token of appreciation. | 47 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 5 |
Baseline characteristics
| Characteristic | Intervention Water UP!@Home | Comparison | Total |
|---|---|---|---|
| Age, Continuous | 31.7 years STANDARD_DEVIATION 6.8 | 32.3 years STANDARD_DEVIATION 7 | 32.03 years STANDARD_DEVIATION 7.33 |
| Country of birth El Salvador | 4 Participants | 8 Participants | 12 Participants |
| Country of birth Ethiopia | 8 Participants | 4 Participants | 12 Participants |
| Country of birth Guatemala | 14 Participants | 18 Participants | 32 Participants |
| Country of birth Mexico | 1 Participants | 3 Participants | 4 Participants |
| Country of birth Nicaragua | 1 Participants | 2 Participants | 3 Participants |
| Country of birth Other | 3 Participants | 6 Participants | 9 Participants |
| Country of birth United States | 14 Participants | 6 Participants | 20 Participants |
| Language of preference: Spanish | 37 Participants | 40 Participants | 77 Participants |
| Parent-reported sex of their child: female | 26 Participants | 23 Participants | 49 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 45 Participants | 47 Participants | 92 Participants |
| Sex: Female, Male Female | 42 Participants | 45 Participants | 87 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Baseline, post-treatment starting 12 weeks after start of intervention, and at most 16 weeks after start of intervention
Population: Parents (adults\> 18 yrs of age) who completed the intervention.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Water Up!@Home | Change in Sugary Drink Consumption for Parents | Baseline oz/day median | 12 oz/day |
| Intervention Water Up!@Home | Change in Sugary Drink Consumption for Parents | Endline oz/day median | 4.57 oz/day |
| Comparison | Change in Sugary Drink Consumption for Parents | Baseline oz/day median | 14.29 oz/day |
| Comparison | Change in Sugary Drink Consumption for Parents | Endline oz/day median | 8.57 oz/day |
Change in Water Consumption for Parents
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
Population: Parent (adults \> 18 yrs old) who completed baseline data collection, endline data collection.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Water Up!@Home | Change in Water Consumption for Parents | Median fluid oz/day at baseline | 27 oz/day |
| Intervention Water Up!@Home | Change in Water Consumption for Parents | Median fluid oz/day at endline | 38.14 oz/day |
| Comparison | Change in Water Consumption for Parents | Median fluid oz/day at baseline | 48 oz/day |
| Comparison | Change in Water Consumption for Parents | Median fluid oz/day at endline | 36.43 oz/day |
Parent 100% Fruit Juice Consumption
Amount of 100% fruit juice consumed (ounces) per day.
Time frame: From baseline up to 16 weeks
Population: Parents who completed the baseline and endline surveys.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Water Up!@Home | Parent 100% Fruit Juice Consumption | Baseline | 2.86 oz/day |
| Intervention Water Up!@Home | Parent 100% Fruit Juice Consumption | Endline | 0 oz/day |
| Comparison | Parent 100% Fruit Juice Consumption | Baseline | 2.86 oz/day |
| Comparison | Parent 100% Fruit Juice Consumption | Endline | 2.86 oz/day |
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
Time frame: Baseline and up to 16 weeks after baseline
Population: Parents who reported on their infant and toddler consumption of beverages
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Water Up!@Home | Parent-reported 100% Fruit Juice Consumption for Their Infant/Toddler | Baseline | 0.71 oz/day |
| Intervention Water Up!@Home | Parent-reported 100% Fruit Juice Consumption for Their Infant/Toddler | Endline | 0.71 oz/day |
| Comparison | Parent-reported 100% Fruit Juice Consumption for Their Infant/Toddler | Baseline | 1.79 oz/day |
| Comparison | Parent-reported 100% Fruit Juice Consumption for Their Infant/Toddler | Endline | 1.79 oz/day |
Parent-reported Sugary Drink Consumption of Their Infant/Toddler
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
Population: Parents' report of their infant/toddler beverage consumption
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Water Up!@Home | Parent-reported Sugary Drink Consumption of Their Infant/Toddler | Baseline (oz/day) Parent-reported sugary drink consumption for infants/toddlers | 0 oz/day |
| Intervention Water Up!@Home | Parent-reported Sugary Drink Consumption of Their Infant/Toddler | Endline- oz/day parent-report on sugary drink consumption of their infants/toddlers | 0 oz/day |
| Comparison | Parent-reported Sugary Drink Consumption of Their Infant/Toddler | Baseline (oz/day) Parent-reported sugary drink consumption for infants/toddlers | 0.29 oz/day |
| Comparison | Parent-reported Sugary Drink Consumption of Their Infant/Toddler | Endline- oz/day parent-report on sugary drink consumption of their infants/toddlers | 0.14 oz/day |
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.
Time frame: Up to 16 weeks from baseline
Population: Parents, who report on their infants/toddlers' beverage consumption
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Water Up!@Home | Parent-reported Water Consumption of Their Infant/Toddler | Median water intake at baseline (oz/day) infants/toddlers (parent reported) | 6 oz/day |
| Intervention Water Up!@Home | Parent-reported Water Consumption of Their Infant/Toddler | Median water intake at endline (oz/day) infants/toddlers (parent reported) | 8 oz/day |
| Comparison | Parent-reported Water Consumption of Their Infant/Toddler | Median water intake at baseline (oz/day) infants/toddlers (parent reported) | 6 oz/day |
| Comparison | Parent-reported Water Consumption of Their Infant/Toddler | Median water intake at endline (oz/day) infants/toddlers (parent reported) | 7.36 oz/day |
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.
Time frame: Baseline
Population: Participants were adults (\>18 yrs old) from cohort 1 (pre-pandemic) randomized to either intervention or comparison group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Water Up!@Home | Body Mass Index for Parents | 29.4 kg/m(2) | Standard Deviation 6.1 |
| Comparison | Body Mass Index for Parents | 29.6 kg/m(2) | Standard Deviation 6.5 |
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).
Time frame: Baseline
Population: Adult parents (\>18 yrs old) who completed baseline data collection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Water Up!@Home | Hip Circumference for Parents | 108.2 cm | Standard Deviation 11.4 |
| Comparison | Hip Circumference for Parents | 106.2 cm | Standard Deviation 13.7 |
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).
Time frame: Baseline
Population: Adults (\>18 yrs old) who completed baseline data collection.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Water Up!@Home | Waist Circumference for Parents | 88.1 cm | Standard Deviation 12.3 |
| Comparison | Waist Circumference for Parents | 89.8 cm | Standard Deviation 12.5 |