Effect of Community Engagement Using M-Mama Champions

NCT06325319 | Not Yet Recruiting

• 1 other identifier: Ref. No. MA.84/261/02/1/115
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the effectiveness of community engagement using M-MAMA Champions on awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women in Bahi, Dodoma. This is a community-based, cluster randomized controlled trial (cRCT) study, whereby 120 first and second-trimester pregnant women will be randomized at a ratio of 1:1 to the intervention and control groups. The intervention of sensitizing pregnant women on Obstetric danger signs, birth preparedness, and complication readiness by the empowered M-MAMA Champions to the intervention arm clusters will be done for one month, a two-hour session will be delivered every two weeks, using participatory learning and action model for women groups to test the effectiveness of M-MAMA Champions in improving literacy level of obstetric danger signs, birth preparedness and complication readiness and its practice among pregnant women. The following is the hypothesis being tested Null Hypothesis; There is no difference in improvement of awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women when community engagement is done using M-MAMA Champions compared to routine approaches. Alternative hypothesis; Community engagement using M-MAMA Champions to improve awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women is more effective than routine approaches. During each 2-hour session, five (5) women will gather up and discuss the obstetric danger signs, birth preparedness, and complication readiness with the assistance of the M-MAMA Champion as a facilitator. An approved brochure on the concerned subject will be used for sensitization. Baseline data will be collected before and after the intervention. The control arm won't receive any intervention.

Conditions

Obstetric Complication; Woman's Role

Outcome Measures

Primary Outcomes (2)

• Improvement in scores from a semi-structured interviewer-administered questionnaire on awareness of obstetric danger signs among pregnant women.

  Change of pregnant women's scores from a semi-structured interviewer-administered questionnaire on the awareness of the obstetric danger signs. It's anticipated that there will be a positive change in scores after the intervention.

  One month (4weeks)

• Improvement in scores from a semi-structured interviewer-administered questionnaire of awareness of birth preparedness and complication readiness among pregnant women

  Change of pregnant women's scores from a semi-structured interviewer-administered questionnaire on awareness of birth preparedness and complication readiness after the intervention. It's anticipated that the majority will be able to name at least three (3) of five (5) key elements of birth preparedness and complication readiness after the intervention.

  One month (4weeks)

Secondary Outcomes (1)

• Improvement in scores from a semi-structured interviewer-administered questionnaire on reported practice of birth preparedness and complication readiness

  One month (4weeks)

Study Arms (2)

M-MAMA Champions group

EXPERIMENTAL

Those study participants randomized to the intervention arm will receive the intervention being tested in this study. The intervention will be community engagement through the M-MAMA Champions on obstetric danger signs, birth preparedness, and complication readiness, whereby sensitization to pregnant women will be done. The sensitization package will be delivered by M-MAMA Champions and will encompass obstetric danger signs, birth preparedness, and complication readiness that will be adapted from the Ministry of Health, Tanzania. The package is being used to empower Community Health Workers (CHWs). The intervention is expected to be delivered in two (2) wards (4 Clusters) to be selected in Bahi Council, Dodoma for a period of one month from March to April 2024 and raise awareness by at least 20% in the intervention arm within a study period.

Other: Community engagement using M-MAMA Champions to improve awareness on obstetric danger signs, bith preparedness and complication readiness among pregnant women

Routine service group

NO INTERVENTION

The study participants who will be randomized to the control arm won't receive the intervention, instead, they will continue receiving the routine services. The routine services for pregnant women specifically on knowledge-related empowerment include the package delivered by the healthcare workers at the reproductive and child health clinics. The package is delivered during every Ante Natal Care (ANC) visit to the pregnant woman. The package contains basic information that is also tailored to the specific needs of pregnant women and is delivered with much emphasis to those who are prone to experience pregnancy-related complications for instance, those with Bad Obstetric History (BOH), cardiovascular diseases, or diabetics. The control groups are expected to be derived from two (2) wards (4 Clusters) to be selected in Bahi Council, Dodoma

Interventions

Community engagement using M-MAMA Champions to improve awareness on obstetric danger signs, bith preparedness and complication readiness among pregnant women OTHER

Community engagement using M-MAMA Champions to improve awareness of obstetric danger signs, birth preparedness, and complication readiness among pregnant women. The empowered M-MAMA Champions will deliver the intervention to pregnant women in their communities. A total of three (3) sessions will be held, whereby each will take two (2) hours. The sensitization will take place at one of the study participant's residential area, where women will gather up and be sensitized on the subject by the M-MAMA Champion as a facilitator using a well-prepared brochure (package).

Also known as: Educational intervention

M-MAMA Champions group

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women in the first and second trimester (up to 28 weeks of GA).

You may not qualify if:

• Pregnant women who will be sick and admitted,
• Mentally incompetent, and
• Those who won't consent to participate in the study.

Sponsors & Collaborators

• University of Dodoma: lead
• Stephen Kibusi: collaborator
• James Tumaini Kengia: collaborator

Study Sites (1)

University of Dodoma

Dodoma, 259, Tanzania

Location

Related Publications (1)

• Sanga A, Kibusi S, Kengia JT. The effectiveness of community engagement using M-Mama champions in improving awareness of obstetric danger signs, birth preparedness and complication readiness among pregnant women in Bahi, Dodoma: A cluster randomized pragmatic implementation trial. PLOS Glob Public Health. 2025 Apr 8;5(4):e0004315. doi: 10.1371/journal.pgph.0004315. eCollection 2025.

  PMID: 40198615 DERIVED

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• James T Kengia, PhD

  University of Dodoma

  STUDY DIRECTOR

Central Study Contacts

Alex P Sanga, Msc. PH

CONTACT

+255762144082; sanga.alex@gmail.com

Stephen Kibusi, PhD

CONTACT

+255712600966; skibusi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 22, 2024
• Study Start: March 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2moths

Locations

TA (1)