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Clinical Trials/NCT07388433
NCT07388433CompletedNot Applicable

Exploring Behavioral Interventions to Improve Adherence to Multiple Micronutrient Supplements Among Pregnant Women in Cambodia

Helen Keller International1 site in 1 country36 target enrollmentStarted: November 1, 2024Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
COM-B-based qualitative themes on determinants of MMS adherence

Study Overview

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.

Detailed Description

This mixed-methods study will explore how three behavioral interventions can support pregnant women in Cambodia to take a daily multiple micronutrient supplement (MMS) as recommended throughout pregnancy and how acceptable and useful these interventions are in their daily lives. The study is being conducted in four provinces in Cambodia (Kampong Chhnang, Ratanakiri, Takeo, and Kampot) and enrolls healthy pregnant women in early pregnancy who attend antenatal care (ANC) at selected health centers. Its findings will help inform Cambodia's planned transition from iron-folic acid to MMS by identifying feasible, family- and community-appropriate strategies to promote high adherence.

The study focuses on three behavioral interventions: (1) a family support session, (2) a tracking calendar, and (3) short educational videos delivered via mobile phone. All enrolled participants are asked to take MMS daily and are sequentially exposed to each of the three interventions, with time between them to try out and reflect on each one. After using each intervention for approximately three weeks, participants join a focus group discussion to describe their experiences, including what helped or hindered their daily MMS intake and what they liked or disliked about the intervention. At each discussion, study staff also count remaining MMS tablets to calculate adherence over that period.

The family support intervention is designed to strengthen the role of close relatives-especially husbands and other key family members-in supporting women's daily MMS intake and broader healthy pregnancy practices. Each pregnant woman is invited to bring two family members of her choice to a one-hour, group-based session at the health center, led by trained midwives and research staff. The session covers essential ANC topics, the benefits and importance of daily MMS, and specific, practical ways family members can help, such as giving reminders, reducing the woman's household workload, or helping her keep MMS in a visible place. Family members can ask questions, discuss challenges, and receive a take-home handout summarizing key messages and suggested supportive actions. Women then return home and experience family support in their everyday context for about three weeks before attending a focus group discussion to describe what kind of support they actually received and how it affected their MMS-taking routine.

The tracking calendar intervention provides a visual tool that women can use at home to monitor and encourage their daily MMS intake and healthy pregnancy behaviors. After completing the family support phase, each participant receives a culturally tailored calendar designed with simple Khmer text and clear illustrations that are suitable for users with varying literacy levels. The calendar includes a daily space to mark when MMS has been taken, reminders for scheduled ANC visits, and icons that promote positive pregnancy practices such as eating a balanced diet and resting, as well as icons indicating behaviors to avoid, such as alcohol use and heavy lifting. Research staff give a short orientation on how to use the calendar, showing women how to mark each day and interpret the symbols. Women then use the calendar at home for about three weeks. A follow-up focus group discussion is conducted to learn how they used the calendar, whether it helped them remember to take MMS, what they found easy or difficult, and what improvements they suggest.

The video intervention uses digital communication to reach women in their homes and reinforce key MMS and pregnancy messages. Over a three-week period, participants receive one short motivational video per week via Telegram, a commonly used messaging application in Cambodia. The videos are in Khmer and feature midwives providing counseling and encouragement on daily MMS adherence, addressing common reasons for missed doses (such as forgetfulness or side effects), and emphasizing the importance of family support. The scripts are developed by the research team with input from maternal health experts, and the videos are pretested with pregnant women not enrolled in the main study to ensure that the messages are clear, relevant, and engaging. At the end of the three-week video period, participants take part in another focus group discussion to share how they watched and understood the videos, what they found most useful or challenging, and whether the videos influenced their MMS-taking habits.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 14 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)

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: Family support session (Behavioral)

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.

Intervention: Tracking Calendar (Behavioral)

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.

Intervention: MMS educational video package (Behavioral)

Outcomes

Primary Outcomes

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

Time Frame: 3-4 weeks after starting each new intervention

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.

Participant ranking of three behavioral interventions for supporting MMS adherence

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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