NCT05774314

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,650

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 11, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

March 6, 2023

Last Update Submit

February 3, 2025

Conditions

Keywords

Community Health Workers

Outcome Measures

Primary Outcomes (1)

  • Child Malnutrition

    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.

    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.

Study Arms (2)

Community Health Worker Intervention

EXPERIMENTAL
Behavioral: Community Health Worker Intervention

No Community Health Worker Intervention

NO INTERVENTION

Interventions

Communities that are randomized into the Treatment arm will receive the Flourish program. Communities with a Flourish program will select and train a Community Health Worker from the Transform program participants. At the end of the Transform program, a Savings Group will be formed from the Transform program participants. The Savings Group will nominate households to participate in the Flourish program and research study. The Community Health Worker will approach the nominees and attempt to enroll them into the Flourish program and research study. If the nominees agree to be enrolled in the Flourish program, the Community Health worker will provide screening, referral, counseling, and treatment services to the household for the duration of the study.

Also known as: Flourish Program
Community Health Worker Intervention

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

ICM

Bohol, Philippines

RECRUITING

ICM

Dipolog City, Philippines

RECRUITING

ICM

Dumaguete, Philippines

RECRUITING

ICM

Koronadal, Philippines

RECRUITING

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Lincoln L Lau, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lincoln L Lau, PhD

CONTACT

Helena Manguerra, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 17, 2023

Study Start

July 11, 2023

Primary Completion

March 1, 2025

Study Completion

May 1, 2025

Last Updated

February 5, 2025

Record last verified: 2025-02

Locations