Men's Club: Impact of Male Partner Involvement on Initiation and Sustainment of Exclusive Breastfeeding Among Postpartum Women

Sponsor
University of Nevada, Las Vegas (Other)
Overall Status
Unknown status
CT.gov ID
NCT03072758
Collaborator
University Of Nigeria Teaching Hospital (Other), Catholic Caritas Foundation, Nigeria (Other)
200
1
2
12
16.6

Study Details

Study Description

Brief Summary

Breastfeeding remains the optimal mode of feeding for infants younger than six months. Exclusive Breast Feeding (EBF) among HIV-infected mothers has been shown to be associated with a sustained and significant reduction in HIV transmission and has the potential to reduce infant and under-five mortality.

Given the considerable authority among men as decision makers in sub-Saharan African, we may be witnessing a missed opportunity to engage men in the education, awareness, and decision-making for EBF. Understanding the role and impact of male partners on this decision-making process require further examination to inform the development of effective and sustainable evidence-based interventions to support the initiation and sustainment of EBF.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Men's Club
N/A

Detailed Description

Summary of the Parent Grant (R01HD087994): The parent grant is a cluster randomized comparative effectiveness trial designed to test the effectiveness of an integrated intervention for sustained testing and retention (iSTAR) on linkage, engagement, and retention among women with HIV infection. The iSTAR intervention provides: confidential, onsite integrated laboratory testing during baby showers; a network of church-based health advisors; clinic based teams trained in motivational interviewing; quality improvement skills to engage and support HIV-infected women; and integrated case management to reduce loss to follow-up. Primary outcomes are the difference in linkage and engagement rates between iSTAR and the clinic-based control group (CG). The secondary outcomes are the difference in retention and viral suppression rate.

Building upon the parent grant, this administrative supplement grant will assess the comparative effectiveness of Men's Club (MC) as intervention group (MC-IG) compared to the control group (MC-CG) on the initiation and sustainment of exclusive breastfeeding. Men's Club is an integrated intervention where male participants receive a five-hour interactive/educational session during their partner's pregnancy, and weekly phone reminders during the first six-week postnatal period to increase EBF knowledge and support strategies, and to improve sustainment of EBF respectively. Male partners in MC-CG will not receive the proposed intervention. Additionally, we will explore barriers and facilitators to support and sustainment of exclusive breastfeeding among participants from both MC-IG and MC-CG in the study. The Primary Outcome is the difference in the rate of initiation and sustainment of EBF between the two groups. The Secondary Outcome is the difference in knowledge of feeding options among male partners and rate of sustained EBF among the female partners in the two groups at 6 months post-delivery.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Men's Club: Impact of Male Partner Involvement on Initiation and Sustainment of Exclusive Breastfeeding Among Postpartum Women
Actual Study Start Date :
Mar 30, 2017
Anticipated Primary Completion Date :
Mar 15, 2018
Anticipated Study Completion Date :
Mar 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Men's Club Intervention Group

Participants randomized to this group will receive interventions from the study team.

Behavioral: Men's Club
Interactive session: This will be a one-day five-hour session that will take place at the church, and will be facilitated by trained lactation nurses. This will involve a maximum of 10 male participants and will occur during the female partner's 3rd trimester. Male partners will (a) complete a structured questionnaire to determine baseline knowledge, attitudes and beliefs about breastfeeding practices, and (b) actively engage in educational information on the benefit of exclusive breastfeeding. At the end of the session, the participants will receive educational pamphlets on breastfeeding to reinforce all the information that had been provided. Phone call reminders: Participants will receive weekly robocalls during the first six weeks following the birth of the infant to reinforce the benefits of exclusive breastfeeding. This will be an automated service that will deliver the calls at a specific time of the day the participants have indicated on their questionnaire.

No Intervention: Men's Club Control Group

Male participants in the control group will receive only education pamphlets related to breastfeeding during the 3rd trimester of their female partner's pregnancy

Outcome Measures

Primary Outcome Measures

  1. Initiation of breastfeeding [6 weeks]

    Provision of mother's breast milk to infants within one hour of birth; participant self-report during face-to-face interview at 6 weeks post-partum

  2. Sustainment of exclusive breastfeeding [3 months]

    Any/exclusive breastfeeding at 3 months is measured using a structured questionnaire at 3 months postnatal

  3. Difference in rates of sustainment of exclusive breastfeeding [6 months]

    Any/exclusive breastfeeding at 6 months is measured using a structured questionnaire at 6 months postnatal

Secondary Outcome Measures

  1. Difference in breastfeeding knowledge [Baseline and 6 weeks]

    Breastfeeding Knowledge Questionnaire (survey) at prenatal timepoint and 6 weeks postpartum

  2. Attitudes towards breastfeeding [6 weeks]

    Iowa Infant Feeding Attitudes Scale (survey) at 6-weeks post delivery

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Cohabiting couples/partners; residing in Benue state, Nigeria identified during iSTAR recruitment (baby showers)
Exclusion Criteria:
  • HIV-infected females who have not disclosed their status to their male partners; male partners who do not own a phone; multiple pregnancy; and any health-related condition that prevents the female partner from breastfeeding.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Catholic Caritas Foundation Makurdi Benue Nigeria

Sponsors and Collaborators

  • University of Nevada, Las Vegas
  • University Of Nigeria Teaching Hospital
  • Catholic Caritas Foundation, Nigeria

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Echezona Ezeanolue, Professor of Public Health and Pediatrics, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier:
NCT03072758
Other Study ID Numbers:
  • 959559-3
First Posted:
Mar 7, 2017
Last Update Posted:
Oct 26, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Echezona Ezeanolue, Professor of Public Health and Pediatrics, University of Nevada, Las Vegas
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2017