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
- 2
- 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
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
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)