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临床试验/NCT05356338
NCT05356338已完成不适用

Expanding Reach of a Health System Intervention for Family Beverage Choice by Partnering With a Local WIC Program

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
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 test the health system-based intervention to improve family beverage choices and promote water consumption, engaging WIC nutritionists to augment the intervention with follow-up and counseling of families at regularly-scheduled WIC appointments in a small randomized trial among 30 WIC-enrolled families.

详细描述

This is a pilot 2-arm randomized trial among 30 WIC enrolled families of children 6 months through 4 years old 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 two educational videos, a water promotion toolkit, mobile phone app, series of educational phone calls and extra counseling from WIC nutritionists, 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
6 Months 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child 6 months - 4 years old who receives health care attention at Wake Forest pediatric or family medicine practices
  • Child enrolled in WIC
  • 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 3 and 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument

次要结局

  • BevQ 15 - Children Change in Servings of Water Consumption(from baseline to month 3, from baseline to month 6)
  • BevQ 15 - Children Change in Servings of 100% Fruit Juice Consumption(from baseline to month 3, from baseline to month 6)
  • BevQ 15 - Children Change in total Volume of Water Consumption(from baseline to month 3, from baseline to month 6)
  • BevQ 15 -Parental Change in Servings of SSBs Consumption(from baseline to month 3, from baseline to month 6)
  • BevQ 15 -Parental Change in Volume of SSBs Consumption(from baseline to month 3, from baseline to month 6)
  • BevQ 15 -Parental Change in Volume of 100% fruit juice Consumption(from baseline to month 3, from baseline to month 6)
  • BevQ 15-Parental Change in Calories of Beverage Consumption(from baseline to month 3, from baseline to month 6)
  • BevQ 15 - Children Change in Servings of SSBs Consumption(from baseline to month 3, from baseline to month 6)
  • BevQ 15 - Children Change in total Volume of SSBs Consumption(from baseline to month 3, from baseline to month 6)
  • BevQ 15 - Children Change in total Volume of 100% Fruit Juice Consumption(from baseline to month 3, from baseline to month 6)
  • BevQ 15 -Parental Change in Servings of 100% Fruit Juice Consumption(from baseline to month 3, from baseline to month 6)
  • BevQ 15 -Parental Change in Volume of Water Consumption(from baseline to month 3, from baseline to month 6)
  • Changes in parent knowledge(from baseline, 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 Servings of Water Consumption(from baseline to month 3, from baseline to month 6)
  • Changes in Parent Attitudes(from baseline, month 6)
  • Changes in Parent Beliefs(from baseline, month 6)
  • Child Weight Change(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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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