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Effectiveness of a Pre-adolescent Inter-generational Intervention to Address HIV and Obesity

2020年3月11日 更新者：Keshni Arthur、University of Witwatersrand, South Africa

Addressing the Double Burden of Diseases Through a Pre-adolescent Transdisciplinary Intervention for Inter-generational Outcomes

The study evaluates an intervention, The CIrCLE of Life Initiative, which was developed to address HIV and obesity prevention. We evaluated whether the combined HIV and obesity intervention increased knowledge, enhanced skills, and/or promoted healthy behaviour among pre-adolescent students (9-12 years old) and their parents.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The CIrCLE of Life Initiative had both a school and home component, each comprising a learning curriculum, environmental support, and activity-based constituents that aimed to increase student knowledge and skills, and to engage parents. Trained educators delivered lessons about HIV and obesity to all Grade 6 students at 5 government-run schools. The classroom curriculum for students required delivery of a five-hour face-to-face intervention delivered weekly through 10 30-minute lessons. Students were asked to communicate their learnings to their parents at home. Parents were requested to read through the lesson in a workbook and to sign acknowledgement that they had read the content. The workbook contained shared student-parent homework activities that took approximately 30 minutes per week.

研究类型

观察性的

注册 (实际的)

852

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 南非
    • Gauteng
      • Westonaria、Gauteng、南非、1779
        • Kamogelo Primary school
      • Westonaria、Gauteng、南非、1779
        • Westonaria primary school
      • Westonaria、Gauteng、南非、1780
        • Westonaria primary mine school
      • Westonaria、Gauteng、南非、1787
        • Zuurbekom Primary School
      • Westonaria、Gauteng、南非、5670
        • Izanokhanyo Primary school

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

9年 至 14年 (孩子)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All Grade 6 learners and their parents from 5 government-run primary schools

描述

Inclusion Criteria:

-

Exclusion Criteria:

-

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Intervention
537 pre-adolescent grade 6 learners and their parent (n=537) were invited to participate. Trained educators delivered lessons about HIV and obesity to all Grade 6 students at 5 government-run schools. The classroom curriculum for students required delivery of a five-hour face-to-face intervention delivered weekly through 10 30-minute lessons. Students were asked to communicate their learnings to their parents at home. Parents were requested to read through the lesson in a workbook and to sign acknowledgement that they had read the content. The workbook contained shared student-parent homework activities that took approximately 30 minutes per week. Data was only collected from Learners (n=425) and parents (n= 427)who had consented to the study. A pretest was conducted. The intervention was then implemented. A posttest was conducted afterwards. Both parents and learners answered self-reported questionnaires.
行为的：The CIrCLE of Life Initiative
HIV and obesity prevention programme delivered directly to Grade 6 preadolescents and indirectly to their parents.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
HIV/AIDS-related knowledge, attitude, behaviour, practices and skills
大体时间：3 months
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
3 months
obesity-related awareness, attitude and skills
大体时间：3 months
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
3 months
nutrition-related awareness, attitude, behaviour and skills
大体时间：3 months
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
3 months
physical activity-related awareness, attitude, behaviour and skills
大体时间：3 months
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
3 months
child-parent communication
大体时间：3 months
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
3 months

次要结果测量

结果测量
措施说明
大体时间
pre-adolescent parent inter-generational knowledge transfer
大体时间：3 months
The second outcome determined whether the intervention, delivered to students, could influence knowledge transfer and translation in parents.
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Witwatersrand, South Africa

合作者

National Institute of Allergy and Infectious Diseases (NIAID)
University of North Carolina, Chapel Hill
Fogarty Clinical Research Inc.

调查人员

  • 研究主任：Gill Nelson, PHD、University of the Witwatersrand, South Africa
  • 研究主任：Nicola Christofides, PHD、University of the Witwatersrand, South Africa

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年5月1日

初级完成 (实际的)

2018年6月30日

研究完成 (实际的)

2018年6月30日

研究注册日期

首次提交

2020年3月11日

首先提交符合 QC 标准的

2020年3月11日

首次发布 (实际的)

2020年3月13日

研究记录更新

最后更新发布 (实际的)

2020年3月13日

上次提交的符合 QC 标准的更新

2020年3月11日

最后验证

2020年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • UWitwatersrand

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD 共享时间框架

Data has already been made available.

IPD 共享支持信息类型

  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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