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临床试验/NCT05774314
NCT05774314招募中不适用

The Impact of Community Health Workers on Child Malnutrition in the Philippines - A Cluster Randomized Controlled Trial

International Care Ministries, Philippines4 个研究点 分布在 1 个国家目标入组 7,650 人开始时间: 2023年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
7,650
试验地点
4
主要终点
Child Malnutrition

研究概览

简要总结

This study will focus on a new community health worker (CHW) program called 'Flourish', which is implemented by Philippine non-governmental organization (NGO) International Care Ministries (ICM). ICM's core program is 'Transform', which is a poverty alleviation program that focuses on households living in ultra-poverty (less than 0.50 United States dollars (USD) per person per day). Transform leverages local community networks to identify 30 participants from the most marginalized households in the community. ICM then provides these participants with 15 weeks of health and livelihood education, as well as with health interventions, including childhood malnutrition treatment.

In ICM's Flourish program, one of the 30 participants in each Transform program is nominated by their peers to become an ICM-supported CHW. The CHWs will not only provide health services after the conclusion of the Transform program for their fellow Transform participants' households, but they will also serve an additional 50+ households in their communities. These additional 'non-Transform' households will be identified by asking the Transform participants to nominate peers in their social networks that share similar socioeconomic backgrounds and whose households are perceived to also benefit from CHW services.

The primary aim of this research is to assess the impact of CHWs on the prevalence of acute childhood malnutrition in hard-to-reach households within low-income communities.

The investigators hypothesize that this study will show that CHWs are able to reduce the prevalence of acute childhood malnutrition in hard-to-reach households within low-income communities.

详细描述

This study will focus on a new community health worker (CHW) program called 'Flourish', which is implemented by Philippine NGO International Care Ministries (ICM). ICM's core program is 'Transform', which is a 15-week poverty alleviation program that focuses on households living in ultra-poverty (less than 0.50 United States dollars (USD) per person per day). ICM runs 'Transform' in approximately 1,000 communities every year. Transform leverages local community networks to identify 30 participants from the most marginalized households in the community. ICM then provides these participants with 15 weeks of health and livelihood education, as well as with health interventions, including childhood malnutrition treatment. During the program, participants are given the opportunity to form a community savings group with the support of ICM. On average, twenty participants per community join these savings groups.

Participants receive a continuation of services from ICM after the Transform program ends. ICM promotes continued economic benefits by supporting the newly formed savings group. ICM also promotes continued health benefits through the 'Flourish' program. In the Flourish program, the savings group elects one person from their membership to serve as a community health worker. This community health worker is trained to screen for illness, provide health counseling, link to primary care, and deliver health commodities to: 1) the savings group's households and 2) the wider community. ICM equips each community health worker with a mobile phone and health commodities. The mobile phone assists the community health worker with screening and follow-up procedures and is also used to collect data on the household members.

A cluster randomized controlled trial will be run to assess the impact of the Flourish program on reducing malnutrition in children between 6 months and 12 years of age. A total of 170 communities will be randomized into two even groups: one arm will receive both the Transform and Flourish programs (Treatment) and one arm will receive the Transform program only (Control).

The maximum number of clusters that ICM can support during the study period is 170, therefore sample size calculations were focused on detectable effect size based on the number of children enrolled per cluster. With significance at 5% and power at 80%, given a background malnutrition rate of 8.5% (based on rates observed in similar settings by ICM) the investigators estimate the ability to detect a reduction of 3% points (35% decrease in malnutrition/ achieving 65% cure rate) if 40 children are enrolled per cluster. To account for potential attrition of ~10%, the study will target 45 children per cluster, which will be a cumulative target of 7,650 (45 x 170) for the whole study. The R package "clusterPower" was used for calculations.

In both arms, each member of the savings group will be asked to nominate up to three households to potentially be approached by ICM community health workers. The nominators will be asked to identify households that are of similar economic status and will be given criteria to help their assessment. Additionally, the households should have at least one child between the ages of 6 months and 12 years who has not previously received an ICM intervention. An ICM staff member will also approach the closest local primary health unit (Barangay Health Station or Rural Health Unit) and request nominations of any households with currently malnourished children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants in the study must meet at least one of the criteria:
  • Transform program participant and member of the savings group formed at the end of Transform
  • Nominated by a savings group member to participate in the study
  • Nominated by the local public health unit (based on confirmed malnutrition status) to participate in the study

排除标准

  • Except for members of the savings group, households cannot participate in the study if they have previously received ICM programs.

结局指标

主要结局

Child Malnutrition

时间窗: Child malnutrition will be assessed only during the endline survey (February-March 2025, 18-months after enrollment into the study). Malnutrition status will be assessed as a single, point-of-time outcome at time of endline survey.

For children under 5 years old, child malnutrition is defined as weight-for-height Z-score less than -2 without edema. For children over 5 years old, child malnutrition is defined as BMI-for-age Z-score less than -2 without edema.

次要结局

未报告次要终点

研究者

发起方
International Care Ministries, Philippines
申办方类型
Other
责任方
Sponsor

研究点 (4)

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