NCT05796934

Brief Summary

This cluster-randomized trial aims to evaluate the impact of the Moments That Matter® (MTM) Program on early child development and caregiving outcomes in two selected counties in western Kenya.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
595

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

2.3 years

First QC Date

March 7, 2023

Last Update Submit

April 10, 2024

Conditions

Child Development

Keywords

early child developmentparentingKenya

Outcome Measures

Primary Outcomes (1)

  • Early child development

    Child development measured using the Caregiver Report of Early Development Index (CREDI) long form version. Scores will be analyzed separately by developmental domain: motor, language, cognitive, and socioemotional development.

    18 months

Secondary Outcomes (4)

  • Caregiver stimulation practices

    18 months

  • Home learning materials

    18 months

  • Caregiver disciplinary practices

    18 months

  • Parenting stress

    18 months

Other Outcomes (7)

  • Infant and young child feeding (IYCF) practices

    18 months

  • Care-seeking for child illness

    18 months

  • Male caregiver involvement

    18 months

  • +4 more other outcomes

Study Arms (2)

Moments that Matter

EXPERIMENTAL

The intervention group will receive the Moments that Matter (MTM) program, which will involve monthly peer group sessions and monthly home visits that are delivered by ECD promoters over an 18-month program duration, training of faith leaders, and the formation of ECD committees at the community-level.

Behavioral: Moments that Matter (MTM) Program

Waitlist-Control

NO INTERVENTION

The control group will not immediately receive the MTM program but instead the standard of care services (e.g., those provided by community health volunteers which are primarily focused on maternal and child health and nutrition). After follow-up assessments are completed for the trial, then villages in the control group will receive the MTM program.

Interventions

Moments that Matter (MTM) ProgramBEHAVIORAL

MTM aims to empower caregivers, enhance nurturing care practices, and ultimately improve early child development (ECD). MTM will be targeted to primary caregivers of children aged 0-3 years and implemented over an 18 month period. The primary program delivery agent will be local volunteers ("ECD promoters") who will facilitate monthly peer group sessions and conduct monthly home visits to participants residing in their village. The MTM curriculum covers topics relating to responsive caregiving, early learning, and child security \& safety, and gender equality. Faith leaders will also be trained to promote nurturing care and ECD within their sermons and Bible study groups. ECD committees will be also formed among leaders across various sectors (e.g., health, education, faith institutions) to promote nurturing care and ECD at the community level and coordinate MTM activities with program staff, delivery agents, and other existing service providers (e.g., community health volunteers).

Moments that Matter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary caregiver (parent or legal guardian) to a child aged 0-18 months
  • Resides in a village selected into the research study
  • Caregiver provides informed consent on behalf of both themself and the child to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anglican Church of Kenya Development Services - Nyanza

Kisumu, Kenya

Location

Related Publications (1)

  • Kalam MA, McCann JK, Shakil Z, Gambari A, Ochieng M, Jeong J. Maternal Mental Health and Child Dietary Diversity in Rural Kenya: Findings From a Pooled Analysis of 2 Baseline Studies. Curr Dev Nutr. 2025 Jun 24;9(7):107497. doi: 10.1016/j.cdnut.2025.107497. eCollection 2025 Jul.

    PMID: 40718429DERIVED

MeSH Terms

Interventions

myotubularin

Study Officials

  • Joshua Jeong, ScD

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

March 7, 2023

First Posted

April 4, 2023

Study Start

February 27, 2023

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)