This study will include 12 rural Head Start programs, randomly assigned to one of two groups: weSIPsmarter vs. control. The main goal is to find out if weSIPsmarter helps reduce sugary drink consumption in preschool-aged children and their parents.
Sugary drinks are the largest single source of calories in the US diet and contribute approximately 8% and 7% of total energy intake for US youth and adults, respectively. Unfortunately, the prevalence of daily sugary drink intake is significantly higher in nonmetropolitan US counties, relative to metropolitan counties (adjusted prevalence ratio = 1.32). Also, an estimated 47% of children age 2-5 consume sugary drinks daily. High sugary drink intake contributes to the development of numerous chronic conditions, including cancer. Despite convincing data on risky sugary drink behaviors in rural counties and among preschool-aged children, there are substantial gaps in the intervention literature. For example, few sugary drink interventions have targeted the needs of US rural regions, few have effectively used scalable technology to reduce child's sugary drinks, and most fail to report on external validity factors. This research addresses these needs and builds on the research team's extensive digital Health expertise and successful sugary drink research within rural communities. Head Starts across defined rural areas (i.e., RUCC 4-9) in Appalachia and the southern Black Belt will be included. The intervention targets parents as the agent of change and aims to improve parent-child dyad outcomes. Phase 1 is guided by the Adaptome framework. In partnership with rural Head Start staff and parents, a user-centered design process will be applied to adapt an existing evidence-based sugary drink interventions to a digital intervention. This new program, called weSIPsmarter, will be a highly interactive, structured program consisting of multiple evidence-based behavioral change components, including use of ecological momentary assessment (EMA) to encourage self-monitoring of beverage behaviors and parenting feeding practices, action planning, a resource help line, and drinking water vouchers for families with concerns related to in-home tap water quality. Phase 2 is guided by RE-AIM and includes a 2 group cluster RCT design \[weSIPsmarter vs. control\] with 3 assessment (pre, 9-week post, and 12-month follow-up) periods. Twelve Head Start center clusters with an average of 31 parent-child dyads per cluster (total of 372 parent-child dyads) will be randomized. It is hypothesized that weSIPsmarter will be more efficacious at reducing sugary drink consumption than control. Changes in secondary outcomes will also be evaluated, including parent-child dyad outcomes (e.g., diet quality, water, BMI, QOL, behavioral theory constructs) and maintenance at 12-months post intervention. Additional secondary aims will examine reach, describe parent engagement, and apply a mixed-methods process evaluation to evaluate adoption and implementation among Head Starts. Mediators and moderators (e.g., social determinant of health indicators) to engagement and efficacy outcomes will be explored, along with organizational-level maintenance. The long-term goal of this primary prevention research is to develop an efficacious sugary drink reduction intervention that has high reach among rural, low socioeconomic, children ages 2-5 and their parents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
744
weSIPsmarter is grounded by the Theory of Planned Behavior as well as Satter's Feeding Dynamic Model. weSIPsmarter will also integrate relevant behavior change techniques and target concepts from health literacy, health numerary, media literacy, and eHealth literacy.
weLearn2Read participants will have access to a website with resources to improve reading readiness, including 6 structured parent lessons, setting reading goals, and 6 children's books (one mailed home each week), and options to receive weekly reminders (e.g., email or text) to encourage reading readiness.
University of Virginia
Christiansburg, Virginia, United States
RECRUITINGChild sugar-sweetened beverage (SSB) ounces
The Beverage Intake Questionnaire for Preschool-aged Children (BEVQ-PS) assesses the intake of sugar-sweetened beverages (SSBs) by measuring the frequency and amount (in ounces) across beverage categories. The ounces are then then aggregated to calculate the total SSB intake in ounces.
Time frame: Baseline and 9 weeks
Child sugar sweetened beverage (SSB) ounces
The Beverage Intake Questionnaire for Preschool-aged Children (BEVQ-PS) assesses the intake of sugar-sweetened beverages (SSBs) by measuring the frequency and amount (in ounces) across beverage categories. The ounces are then then aggregated to calculate the total SSB intake in ounces.
Time frame: 12 month
Parent sugar-sweetened beverage (SSB) ounces
The Beverage Intake Questionnaire (BEVQ-15) assesses the intake of sugar-sweetened beverages (SSBs) by measuring the frequency and amount (in ounces) across beverage categories. The ounces are then then aggregated to calculate the total SSB intake in ounces.
Time frame: Baseline, 9 weeks, 12 months
Child Weight in pounds
Measured using a cellular enabled in-home BodyTrace digital scale
Time frame: Baseline, 9 weeks, 12 months
Child Height in feet and inches
Measured via stadiometer
Time frame: Baseline, 9 weeks, 12 months
Child Body Mass Index (BMI) Percentile
Child's Body Mass Index (BMI) will be calculated using the standard formula: weight(kg)/height(m)2. BMI z-score will be calculated using CDC growth charts and converted to BMI-for-age percentile based on CDC growth charts for children and teens ages 2 through 19.
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Time frame: Baseline, 9 weeks, 12 months
Parent Weight in pounds
Measured using a cellular enabled in-home BodyTrace digital scale.
Time frame: Baseline, 9 weeks, 12 months
Parent Height in feet and inches
Self-reported
Time frame: Baseline
Parent Body Mass Index (BMI)
Parent's Body Mass Index (BMI) will be calculated using the standard formula: weight(kg)/height(m)2.
Time frame: Baseline, 9 weeks, 12 months
Parent number of unhealthy days
The number of unhealth days, a measure of Quality of Life (QOL), will be assessed using Center's for Disease Control Healthy Day module. Higher number of days means worse outcome.
Time frame: Baseline, 9 weeks, 12 months
Proportion of parents with limited health literacy
Assessed using the Newest Vital Sign. Scores range from 0-6 with 0-4 considered limited health literacy and 5-6 considered to be adequate health literacy.
Time frame: Baseline, 9 weeks, 12 months
Parent sugary-sweetened beverage (SSB) media literacy score
Measured with sugary-sweetened beverage (SSB) media literacy instrument which includes 6 items measured on a 7-point Likert scale (1, strongly disagree; 7, strongly agree). Scores range from 7-42; Higher scores equate to higher SSB media literacy.
Time frame: Baseline, 9 weeks, 12 months
eHealth digital literacy score
The eHEALS digital literacy test is an 8-item measure of eHealth literacy developed to measure the participants combined knowledge, comfort and perceived skills at finding, evaluating and applying electronic health information to health problems. The test is measured with a 5-point Likert scale with response options ranging from "strongly disagree" to "strongly agree." Total scores of the eHEALS are summed to range from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.
Time frame: Baseline, 9 weeks, 12 months
Division of Responsibility (DOR) feeding approach score
Assessed using Satter Parent-Child Feeding Measure (sDOR.2-6y™). Includes 12 times, with scores ranging from 0-32. Higher scores indicate greater adherence to the Division of Responsibility (DOR) feeding approach.
Time frame: Baseline, 9 weeks, 12 months
Frequency of sugar-sweetened beverages (SSB) in the home
Home availability of 7 categories of sugar sweetened beverages (SSB) in the home. Responses are on a 5-point Likert scale (1, never; 5, always). Scores range from 7-35, with higher scores meaning higher home availability of SSB.
Time frame: Baseline, 9 weeks, 12 months
Child fruits and vegetables (cup equivalents per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into fruits and vegetables cup equivalents per day.
Time frame: Baseline, 9 weeks, 12 months
Child added sugars (teaspoon equivalents per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into added sugars teaspoon equivalents per day.
Time frame: Baseline, 9 weeks, 12 months
Child added sugars from sugar-sweetened beverages (teaspoon equivalents per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into added sugars from sugar-sweetened beverages teaspoon equivalents per day.
Time frame: Baseline, 9 weeks, 12 months
Child dairy (cup equivalents per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into dairy cup equivalents per day.
Time frame: Baseline, 9 weeks, 12 months
Child whole grains (ounce equivalents per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into whole grains ounce equivalents per day.
Time frame: Baseline, 9 weeks, 12 months
Child calcium (milligrams per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into calcium milligrams per day.
Time frame: Baseline, 9 weeks, 12 months
Child fiber (grams per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into fiber grams per day.
Time frame: Baseline, 9 weeks, 12 months
Child red meat (times per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into red meat times per day.
Time frame: Baseline, 9 weeks, 12 months
Child processed meat (times per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into processed meat times per day.
Time frame: Baseline, 9 weeks, 12 months