Pilot randomized trial of a technology-based intervention to reduce sugary drink consumption and promote water intake in families with young children.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
120
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
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
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
Time frame: 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
Time frame: from baseline to month 6
BevQ 15 - Children Change in Servings of Beverages
changes in total servings children including water and unsweetened milk
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from baseline to month 3, from baseline to month 6
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BevQ 15 -Parental Change in Beverage Consumption
changes in total servings for parents including water and unsweetened milk
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: from baseline to month 3, from baseline to month 6
Child Weight Change
change in child weight (kg) using Electronic Health Record (EHR) data
Time frame: 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
Time frame: from baseline to month 3, from baseline to month 6