Intervention to Reduce Sugar-Sweetened Beverage (SSB) Consumption in Children and Families

Study Overview
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Brief Summary
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Pilot randomized trial of a technology-based intervention to reduce sugary drink consumption and promote water intake in families with young children.

Detailed Description
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This is a pilot 2-arm randomized trial among 60 families of 1-8 year old children 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 an educational video, water promotion toolkit, mobile phone app, and series of educational phone calls, 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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A Health Systems Intervention to Reduce Sugar-Sweetened Beverage Consumption in Young Children and Families

Conditions
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Obesity, Childhood

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child 1-8 years old who receives health care attention at Wake Forest pediatric or family medicine practices 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: 1 Year

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 group 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, and a children's book about water consumption, as well as instructions for other intervention components (how to view video, download app, and prepare for calls) A 5-minute educational video that introduces parents to healthy drink choices for the family. Ready, Set Gulp! A smartphone application 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. | Behavioral: Pilot Intervention to reduce SSB consumption in children and families<br>* A 6-month intervention based on the use of 4 components: an educational video, provision of a water-promotion toolkit, a mobile phone application (app), and a series of 14 computerized interactive voice response (IVR) phone calls to parents 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 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 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 Beverages | changes in total servings children including water and unsweetened milk | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 - Children Change in total Volume of Beverages | changes in total volume of beverages consumed by children including water and unsweetened milk | 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 including water and unsweetened milk | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 -Parental Change in Sugary beverage consumption | changes in parental beverage consumption sugary drink serving | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 -Parental Change in Beverage Consumption | changes in total servings for parents including water and unsweetened milk | from baseline to month 3, from baseline to month 6 | 
| BevQ 15 -Parental Change in Volume of Beverage Consumption | changes in total volume for parents including water and unsweetened milk | 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 including water and unsweetened milk | 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, including how SSB are related to possible health consequences and perceived healthfulness of different beverages. | from baseline to month 3, from baseline to 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 to month 3, from baseline to 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 to month 3, from baseline to 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 |