Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05774314 |
Other study ID # |
icmflourishrct |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 11, 2023 |
Est. completion date |
July 2024 |
Study information
Verified date |
February 2024 |
Source |
International Care Ministries, Philippines |
Contact |
Lincoln L Lau, PhD |
Phone |
6478520288 |
Email |
lincoln.lau[@]utoronto.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
The list of savings group households and their nominated households will be collected by an
ICM staff member. Each household will receive an explanation that by enrolling in this study,
they may be approached by a future ICM community health worker program. Only people enrolled
in the Treatment arm of this study will be approached to participate in the community health
worker program; however, all study participants will receive a free child malnutrition
screening in July 2024. At that screening, any child between 6m-12 years who is identified as
malnourished will be linked to care and provided treatment for malnutrition. Only consenting
households will be enrolled into the study. In both arms, participation is completely
voluntary, and participants are allowed to withdraw at any time and still receive the
screening in 2024.
All households enrolled in the study will also receive a short baseline survey in July 2023
and endline survey in July 2024. Surveys will be conducted by trained enumerators. The
baseline survey will primarily collect household identification and demographic information.
The baseline data will also be analyzed to determine the balance between Treatment and
Control participants on key characteristics.
In the Treatment arm, the community health worker will attempt to register all consenting
savings group households into the Flourish program. They will also attempt to register the 50
additional households from the nominee list into the Flourish program. The CHW must obtain
consent from the heads of households of their participation in the community health worker
program before registering the household.
Over time, the community health worker may continue to enroll additional households in the
Flourish program, including households who were nominated by the Savings Group but not
originally registered in the Flourish program. Households who did not consent to the study
may also be registered into the Flourish program, as long as they provide consent for
registration. However, households who were not on the original list of nominees will not be
included as study participants.
In July 2024, one year after household enrollment, enumerators will return to every household
in both the Treatment and Control arms. The enumerators will conduct an endline survey and
collect the age, weight, height, and mid-upper arm circumference of each child. In the
Treatment arm, children identified as wasted who are not already on malnutrition follow-up
will be flagged for the community health worker to register into the Flourish program (if not
already) and receive malnutrition follow-up and treatment from the CHW. In the Control arm,
children identified as wasted will be referred to the closest primary health service provider
(Barangay Health Station or Rural Health Unit), and if provisions are not adequate ICM will
follow up with these children and their households.
The following analyses will be conducted for the primary research objective to assess the
impact of the Flourish program on malnutrition in children aged 6 months to 12 years old at
time of enrollment:
- A logistic regression model with clustered standard errors will be used to analyze the
difference in prevalence of malnutrition (WHZ <-2) between Control and Treatment.
- A linear regression model with clustered standard errors will be used to analyze the
difference in mean weight-for-height Z-score between Control and Treatment.