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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 Sciences1 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
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
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 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
是

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

研究组 & 干预措施

Control

No Intervention

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

Experimental

Intervention 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, children's book about water consumption, and instructions for other intervention components (how to view videos, download app, and prepare for calls) Two brief educational videos: a 5-minute video about healthy drink choices for the family and a 3-min video educating residents about local water. Ready, Set Gulp! app 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.

Two counseling sessions by a WIC nutritionist at months 2 and 4

干预措施: Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC (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 3 and 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 and 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument

次要结局

  • 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)
  • BevQ 15 - Children Change in Servings of Water Consumption(from baseline to month 3, from baseline to 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)
  • BevQ 15 - Children Change in Servings of 100% Fruit Juice Consumption(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 (1)

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