NCT07388433

Brief Summary

The goal of this mixed method study is to learn how three different behavioral interventions can help pregnant women in Cambodia take a daily multiple micronutrient supplement (MMS) as recommended during pregnancy and to understand how acceptable and useful these interventions are for them. The main questions it aims to answer are:

  • How do family support sessions, a tracking calendar, and short educational videos help pregnant women remember to take MMS every day and follow healthy pregnancy practices?
  • Which of these three interventions do pregnant women find most helpful and acceptable for supporting daily MMS use? Researchers will compare the three interventions (family support, tracking calendar, and educational videos) to see which approach best supports high MMS adherence and is most preferred by pregnant women. Participants will:
  • Take MMS tablets every day during pregnancy, starting from early pregnancy.
  • Invite two family members to attend a one-hour group session at the health center about MMS and healthy pregnancy, including how families can support daily supplement use.
  • Use a culturally tailored tracking calendar at home for three weeks to mark each day they take MMS and see reminders about clinic visits and healthy pregnancy behaviors.
  • Receive one short motivational video per week for three weeks via Telegram, featuring midwives who explain MMS, answer common concerns, and encourage daily supplement use.
  • Join focus group discussions after each intervention to share their experiences, preferences, and suggestions, and have remaining tablets counted to measure how many doses they took.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 9, 2026

Last Update Submit

January 30, 2026

Conditions

Keywords

multiple micronutrient supplementspregnancyadherenceimplementation scienceCambodiabehavior changeCOM-B model

Outcome Measures

Primary Outcomes (2)

  • COM-B-based qualitative themes on determinants of MMS adherence

    Thematic analysis (content analysis) of FGD transcripts mapped onto COM B domains (capability, opportunity, motivation) to identify perceived barriers and facilitators related to each intervention and MMS adherence.

    3-4 weeks after starting each new intervention

  • Participant ranking of three behavioral interventions for supporting MMS adherence

    Participants rank family support, tracking calendar, and educational videos from 1 (most effective) to 3 (least effective) in supporting daily MMS adherence and healthy pregnancy practices; rankings summarized descriptively overall and by province.

    At endline or approximately 90 days after enrollment, following completion of all three interventions.

Other Outcomes (2)

  • MMS adherence (%) over the intervention period

    3-4 weeks from start of each intervention

  • Acceptability of MMS and behavioral interventions

    At endline or approximately 90 days after enrollment, following completion of all three interventions.

Study Arms (1)

Family Support Session; Tracking Calendar, and MMS eduational video package

EXPERIMENTAL

Single cohort of pregnant women receiving multiple micronutrient supplements throughout pregnancy plus sequential exposure to three behavioral interventions (family support session, tracking calendar, and educational SMS-style videos) to support daily MMS adherence and healthy pregnancy practices.

Behavioral: Family support sessionBehavioral: Tracking CalendarBehavioral: MMS educational video package

Interventions

One 1 hour group session at the health center in Khmer for each participant and two self selected family members, facilitated by trained midwives and research staff, covering antenatal care, importance of daily MMS, and specific actions family members can take (reminders, workload support, healthy behaviors); includes interactive discussion and a summary handout for each family member.

Family Support Session; Tracking Calendar, and MMS eduational video package

Culturally tailored wall calendar designed by a social marketing group, pretested with pregnant women, with daily visual tick boxes to mark MMS intake, reminders for ANC visits, and illustrated messages on recommended and discouraged pregnancy behaviors; provided with in person orientation on use and kept at home for at least 3 weeks.

Family Support Session; Tracking Calendar, and MMS eduational video package

Three short Khmer language videos (one per week over 3 weeks) sent via Telegram, featuring midwives providing counseling on daily MMS, managing side effects, healthy pregnancy practices, and the role of family support; scripts developed by the research team and maternal health experts and pretested with pregnant women.

Family Support Session; Tracking Calendar, and MMS eduational video package

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identified women who are currently pregnant and meet all other eligibility criteria are eligible to participate.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • weeks' gestation at first ANC visit (low risk, singleton pregnancy)
  • Attending first ANC visit at one of the participating health centers in Kampong Chhnang, Ratanakiri, Takeo, or Kampot
  • Residing in one of the four study provinces with no plans to relocate in the next 4 months
  • Willing to take MMS as prenatal supplement for the study period
  • Willing to participate in three focus group discussions (plus final ranking discussion)

You may not qualify if:

  • Pregnancy classified as high risk by the healthcare provider (any medical condition that makes pregnancy high risk)
  • Plan to relocate outside the four study provinces within 4 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prey Khmer Health Center in Kampong Chhnang; Prambei Mom Health Center in Takeo Province; Chakrey Ting Health Center in Kampot Province; Kon Mon Health Center in Ratanakiri Province

Phnom Penh, Cambodia

Location

Study Officials

  • Mai-Anh Hoang, Master of Public Health

    Helen Keller Intl

    PRINCIPAL INVESTIGATOR
  • Kim Rattana, Medical Doctor

    Minstry of Health of Cambodia, National Maternal and Child Health Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2026

First Posted

February 5, 2026

Study Start

November 1, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

February 5, 2026

Record last verified: 2026-01

Locations