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临床试验/NCT05011292
NCT05011292已完成不适用

Strengthening and Supporting the Diabetes Early Prevention Efforts of Pediatric Primary Healthcare Providers

Emory University2 个研究点 分布在 1 个国家目标入组 388 人开始时间: 2021年8月10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
388
试验地点
2
主要终点
Percentage of Parents Who Report That They do Not Give Their Young Children Fruit Juice

研究概览

简要总结

The purpose of this study is to determine if incorporating videos on the importance of minimizing infant sugar-containing beverage (SCB) consumption into well-child visit protocols increases parents' SCB-related knowledge and their compliance with related early feeding recommendations. The study also aims to determine whether these videos increase the frequency and quality of the SCB-related reduction education and counseling provided to parents during well-child visits.

详细描述

The purpose of this study is to determine if incorporating videos on the importance of minimizing infant sugar-containing beverage (SCB) consumption into well-child visit protocols increases parents' SCB-related knowledge and their compliance with related early feeding recommendations. The study also aims to determine whether these videos increase the frequency and quality of the SCB-related reduction education and counseling provided to parents during well-child visits.

The populations to be studied include:

  1. Parents of children attending a 4, 6, 9, 12 or 15-month well-child visit (Main study)
  2. A subsample of parents from above that agree to complete a baseline and follow-up knowledge and practice survey 5 to 6 months after enrollment. (Long-Term follow-up study)
  3. Members of the clinic team who participate in the project (Key informant interviews)

Participants in the main study will include parents attending a 4-month, 6-month, 9-month, 12-month or 15-month well-child visit at Hughes Spalding clinic, Atlanta GA. During their 4-month or 12-month clinic visit, parents will be offered to view a video (3 minutes) and complete a short survey about it afterwards (2 minutes). Parents attending their child's 6, 9 or 15-month well-child visit will be asked to complete a short survey about infant feeding practices (3-4 minutes). No identifying information will be collected. A waiver of consent is being requested for this component of the study.

A subsample of the parents referenced above will be invited by co-investigators on the clinic team to participate in a long-term follow-up survey to assess the extent to which viewing the well-child visit videos has an impact of knowledge and/or behavior that is sustained. Those who consent will be asked to provide their first name and email address in order to enable the follow up survey to be completed on-line. No other PHI will be collected. A study ID will be assigned and only the PI and the statistician will have access to the code that links identifiers to subjects. Sub sample participants will be asked to view a video at the child's 4-month or 12-month well-child visit, to complete a survey assessing their response to the video as well as their infant feeding practices. This survey will be repeated during their 6-month or 15-month well-child visit and again, by email, 2 to 3 months later. Total participation time is expected to be <20 minutes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being over 18 years of age, AND
  • Being a parent/caregiver of a child age 4-15 months, AND
  • Attending a well-child visit at the collaborating pediatric primary care clinic and planning to continue during the pilot implementation.

排除标准

  • Parents/caregivers with cognitive or behavioral limitations that preclude completion of the survey
  • Parents/caregivers of children with conditions that require special feeding protocols, e.g. tube feedings, high calorie supplements
  • Parent/caregivers who are not able to communicate in English

结局指标

主要结局

Percentage of Parents Who Report That They do Not Give Their Young Children Fruit Juice

时间窗: 2-3 months post-intervention

Parents will be asked if they give their young child fruit juice. Response options will be "yes" or "no". Participants responding "no" are reported.

Percentage of Parents Who Report That They do Not Give Their Young Children Sugar-sweetened Beverages.

时间窗: 2-3 months post-intervention

Parents will be asked if they give their young child sugar-sweetened beverages. Response options will be "yes" or "no". Percentage of parents who report"no" will be reported.

Percentage of Parents Who Are Aware of Infant Fruit Juice Consumption Recommendations

时间窗: 0-3 months post-intervention

This will be assessed by asking parents if they are "aware of any expert recommendations related to the age or amount of fruit juice given to infants and/or young children?". Those responding "yes" will be asked to specify the recommendation. If their response is correct, they will be recorded as knowledgeable.

次要结局

  • Percentage of Clinic Staff Who Report That the SCB Consumption Related Videos Were Easy to Incorporate Into the Flow of Clinic Operations(Up to 9 months post-intervention)
  • Percentage of Parents Who Viewed an Intervention Video Report That They Enjoyed it(immediately post-intervention, within 30 minutes)
  • Percentage of Parents Who Viewed an Intervention Video Report That They Learned Something From it(immediately post-intervention, within 30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean Welsh

Associate Professor

Emory University

研究点 (2)

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