Intervention to Reduce Sugar-Sweetened Beverage (SSB) Consumption in Children and Families
- Conditions
- Obesity, Childhood
- Interventions
- Behavioral: Pilot Intervention to reduce SSB consumption in children and families
- Registration Number
- NCT04886817
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
Pilot randomized trial of a technology-based intervention to reduce sugary drink consumption and promote water intake in families with young children.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Pilot Intervention to reduce SSB consumption in children and families Intervention group participants will receive a 6-month behavioral intervention with the following components: 1. 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) 2. A 5-minute educational video that introduces parents to healthy drink choices for the family. 3. 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. 4. 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.
- Primary Outcome Measures
Name Time Method Change in child sugary drink serving consumption from baseline to month 6 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
- Secondary Outcome Measures
Name Time Method BevQ 15-Parental Change in Calories of Beverage Consumption from baseline to month 3, from baseline to month 6 changes in total beverage calories for parents including water and unsweetened milk
Changes in parent knowledge from baseline to month 3, from baseline to month 6 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.
BevQ 15 - Children Change in Servings of Beverages from baseline to month 3, from baseline to month 6 changes in total servings children including water and unsweetened milk
BevQ 15 - Children Change in total Volume of Beverages from baseline to month 3, from baseline to month 6 changes in total volume of beverages consumed by children including water and unsweetened milk
BevQ 15 - Children Change in total calories of beverages consumption from baseline to month 3, from baseline to month 6 Changes in calories of beverages consumed by children including water and unsweetened milk
BevQ 15 -Parental Change in Beverage Consumption from baseline to month 3, from baseline to month 6 changes in total servings for parents including water and unsweetened milk
Changes in Parent Attitudes from baseline to month 3, from baseline to month 6 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.
Child Body Mass Index Z-Score (BMIz) Change from baseline to month 3, from baseline to month 6 change in child BMIz also using EHR data
BevQ 15 -Parental Change in Volume of Beverage Consumption from baseline to month 3, from baseline to month 6 changes in total volume for parents including water and unsweetened milk
Changes in Parent Beliefs from baseline to month 3, from baseline to month 6 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.
Child Weight Change from baseline to month 3, from baseline to month 6 change in child weight (kg) using Electronic Health Record (EHR) data
BevQ 15 -Parental Change in Sugary beverage consumption from baseline to month 3, from baseline to month 6 changes in parental beverage consumption sugary drink serving
Trial Locations
- Locations (1)
Wake Forest School of Medicine
🇺🇸Winston-Salem, North Carolina, United States