Expanding Health System Intervention Through The Women, Infants and Children (WIC) Program Partnership

Study Overview
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Brief Summary
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Pilot test the health system-based intervention to improve family beverage choices and promote water consumption, engaging WIC nutritionists to augment the intervention with follow-up and counseling of families at regularly-scheduled WIC appointments in a small randomized trial among 30 WIC-enrolled families.

Detailed Description
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This is a pilot 2-arm randomized trial among 30 WIC enrolled families of children 6 months through 4 years old who currently over-consume sugary drinks. The study team will randomize families to either an intervention group, that will receive a behavioral intervention consisting of two educational videos, a water promotion toolkit, mobile phone app, series of educational phone calls and extra counseling from WIC nutritionists, or to a control group that will not receive this intervention. The study team will compare 6-month change in child and parental beverage consumption between groups. Exploratory analyses will examine child weight (kg) and Body Mass Index (BMI) z-score (BMIz) outcomes, and compare intervention effects across race/ethnic groups.

Official Title
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Expanding Reach of a Health System Intervention for Family Beverage Choice by Partnering With a Local WIC Program

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Behavioral: Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child 6 months - 4 years old who receives health care attention at Wake Forest pediatric or family medicine practices Child enrolled in WIC Child consumes 2 or more SSB and/or fruit juice total per day Child with no chronic health condition Child has not seen nutritionist or visited our family-based weight management clinic in the past year Parent/caregiver who has not watch educational video Get in the Zero Zone Parent/caregiver has a smartphone and reliable internet Parent/caregiver able to communicate well in English Exclusion Criteria: Child doesn't meet age criteria Child consumes less than 2 SSB and/or fruit juice total per day Child with a chronic health condition Child has seen nutritionist or visited our family-based weight management clinic in the past year Parent/caregiver has watched educational video Get in the Zero Zone Parent/caregiver has completed interview or usability test Parent/caregiver doesn't have a smartphone or reliable internet Parent/caregiver not able to communicate well in English

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control group participants in this study will not receive any intervention as is the current standard of clinical care for excess sugary drink consumption. They will receive monthly check-in reminders from research staff to promote engagement and retention and will participate in data collection visits at baseline, 3 and 6 months. | |
| Experimental: Intervention<br>Intervention participants will receive a 6-month behavioral intervention with the following components: A water promotion toolkit that includes water bottles, water flavor infusers, stickers to decorate bottles, children's book about water consumption, and instructions for other intervention components (how to view videos, download app, and prepare for calls) Two brief educational videos: a 5-minute video about healthy drink choices for the family and a 3-min video educating residents about local water. Ready, Set Gulp! app for families that will help all family members track their beverage intake, find out how much water and sugar they are consuming, set goals, compete for points, answer quiz questions and create new recipes for flavor infused water. A series of 14 interactive voice response phone calls to parents over 6 months that educate parents on topics relevant to improving family drink choices. Two counseling sessions by a WIC nutritionist at months 2 and 4 | Behavioral: Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC<br>* A 6-month intervention based on the use of 5 components: 2 educational videos, provision of a water-promotion toolkit, a mobile phone application (app), a series of 14 computerized interactive voice response (IVR) phone calls to parents and 2 counseling sessions by a WIC nutritionist to compare families' SSB's consumption behaviors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child sugary drink serving consumption | change in a child's combined consumption of Sugar-Sweetened Beverages (SSB)+Fruit Juice (FJ), measured as total servings per day, at 3 and 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument | from baseline to month 3 | 
| Change in child sugary drink serving consumption | change in a child's combined consumption of Sugar-Sweetened Beverages (SSB)+Fruit Juice (FJ), measured as total servings per day, at 3 and 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument | from baseline to month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BevQ 15 - Children Change in Servings of Water Consumption | changes in total servings of water consumed by children | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 - Children Change in Servings of SSBs Consumption | changes in total servings of SSBs consumed by children | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 - Children Change in Servings of 100% Fruit Juice Consumption | changes in total servings of 100% fruit juice consumed by children | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 - Children Change in total Volume of Water Consumption | changes in total volume of water consumed by children | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 - Children Change in total Volume of SSBs Consumption | changes in total volume of SSBs consumed by children | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 - Children Change in total Volume of 100% Fruit Juice Consumption | changes in total volume of 100% fruit juice consumed by children | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 - Children Change in total calories of beverages consumption | Changes in calories of beverages consumed by children | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 -Parental Change in Servings of Water Consumption | Changes in total servings of water consumed by parents | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 -Parental Change in Servings of SSBs Consumption | Changes in total servings of SSBs consumed by parents | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 -Parental Change in Servings of 100% Fruit Juice Consumption | Changes in total servings of 100% fruit juice consumed by parents | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 -Parental Change in Volume of Water Consumption | changes in total volume of water consumed by parents | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 -Parental Change in Volume of SSBs Consumption | changes in total volume of SSBs consumed by parents | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 -Parental Change in Volume of 100% fruit juice Consumption | changes in total volume of 100% fruit juice consumed by parents | from baseline to month 3, from baseline to month 6 | 
| BevQ 15-Parental Change in Calories of Beverage Consumption | changes in total beverage calories for parents | from baseline to month 3, from baseline to month 6 | 
| Changes in parent knowledge | Survey knowledge items will be scored in terms of correct or not with a range of 0-17 possible points, with higher score demonstrating more knowledge about SSB and FJ. | from baseline, month 6 | 
| Changes in Parent Attitudes | Attitude and belief items will be reported individually, as these are not objectively correct or incorrect and represent a subjective state of the parent's point of view. These will be reported out as frequencies / descriptive statistics, with change in proportion responding a certain way examined over follow-up. Statistician will use Statistical Analysis Software (SAS) for quantifying qualitative data. | from baseline, month 6 | 
| Changes in Parent Beliefs | Belief items will be reported individually, as these are not objectively correct or incorrect and represent a subjective state of the parent's point of view. These will be reported out as frequencies / descriptive statistics, with change in proportion responding a certain way examined over follow-up. Statistician will use Statistical Analysis Software (SAS) for quantifying qualitative data. | from baseline, month 6 | 
| Child Weight Change | change in child weight (kg) using Electronic Health Record (EHR) data | from baseline to month 3, from baseline to month 6 | 
| Child Body Mass Index Z-Score (BMIz) Change | change in child BMIz also using EHR data | from baseline to month 3, from baseline to month 6 |