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 February-March 2025. 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 2025.
All households enrolled in the study will also receive a short baseline survey in July
2023 and endline survey in February-March 2025. 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 February 2025, 18-months 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.