A Health Systems Intervention to Reduce Sugar-Sweetened Beverage Consumption in Young Children and Families
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in child sugary drink serving consumption
研究概览
简要总结
Pilot randomized trial of a technology-based intervention to reduce sugary drink consumption and promote water intake in families with young children.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study staff collecting data on the primary outcome of beverage consumption at 3 and 6 month follow-up will be blinded to group allocation of participants.
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
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.
Intervention
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.
干预措施: Pilot Intervention to reduce SSB consumption in children and families (Behavioral)
结局指标
主要结局
Change in child sugary drink serving consumption
时间窗: 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
Change in child sugary drink serving consumption
时间窗: from baseline to month 3
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
次要结局
- BevQ 15-Parental Change in Calories of Beverage Consumption(from baseline to month 3, from baseline to month 6)
- Changes in parent knowledge(from baseline to month 3, from baseline to month 6)
- BevQ 15 - Children Change in Servings of Beverages(from baseline to month 3, from baseline to month 6)
- BevQ 15 - Children Change in total Volume of Beverages(from baseline to month 3, from baseline to month 6)
- BevQ 15 - Children Change in total calories of beverages consumption(from baseline to month 3, from baseline to month 6)
- BevQ 15 -Parental Change in Beverage Consumption(from baseline to month 3, from baseline to month 6)
- Changes in Parent Attitudes(from baseline to month 3, from baseline to month 6)
- Child Body Mass Index Z-Score (BMIz) Change(from baseline to month 3, from baseline to month 6)
- BevQ 15 -Parental Change in Volume of Beverage Consumption(from baseline to month 3, from baseline to month 6)
- Changes in Parent Beliefs(from baseline to month 3, from baseline to month 6)
- Child Weight Change(from baseline to month 3, from baseline to month 6)
- BevQ 15 -Parental Change in Sugary beverage consumption(from baseline to month 3, from baseline to month 6)