Breastfeeding Education Support Tool for Baby

NCT ID: NCT03533725

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2020-06-30

Brief Summary

This study will compare data associated with breastfeeding experiences and outcomes--specifically, breastfeeding continuation after initiation, exclusivity for 6 months of an infant's life, and breastfeeding duration--among 120 subjects recruited late in pregnancy and provided peer counseling and education services incorporating mobile health (mHealth) tools during a period of at least 6 months post-delivery with the data collected from a control group of approximately 120 mothers that did not receive the study intervention.

Detailed Description

Approximately 24 women that are experienced in breastfeeding will be recruited to serve in the role of breastfeeding peer counselors. These women will assess usability and acceptability of mobile health (mHealth) education tools designed following a series of focus groups for the project, Breastfeeding Education Support Tool for Baby. The mHealth tools will be used during the training and education of the peer counselor subjects. Following appropriate modification, some of the mHealth tools will be used with a total of approximately 120 women recruited late in pregnancy for initial breastfeeding counseling before delivery and the subsequent provision, for at least 6 months post-delivery, of home visits for peer counseling and education that integrates use of mHealth tools. Peer counselors and research staff will gather data from mothers receiving the intervention about breastfeeding experiences and outcomes, including breastfeeding continuation after initiation, exclusivity for 6 months of an infant's life, and breastfeeding duration. This data will be compared to data obtained through surveys administered to a control group of approximately 120 maternal subjects that received standard pre- and post-delivery care but not the study intervention of peer counseling and education using mHealth tools.

Conditions

Breastfeeding

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention group

Breastfeeding counseling and education services using mHealth tools

Group Type: EXPERIMENTAL

Breastfeeding counseling and education services

Intervention Type: OTHER

Breastfeeding counseling and education by educated and trained peer counselors using mHealth tools

Comparative control group

No intervention, only standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Breastfeeding counseling and education services

Breastfeeding counseling and education by educated and trained peer counselors using mHealth tools

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Personal experience with breastfeeding - Residence in an intervention cluster

• Willingness to consent to assignment to a breastfeeding peer counselor and to participate in counseling and education visits
• Residence in an intervention cluster and intent to remain in the intervention area for a minimum of 6 months post-delivery

• Mothers delivering during the study period that live in a non-intervention area that has been designated for recruitment of control subjects
• Willingness to participate in a survey enabling collection of data for comparative purposes

Exclusion Criteria

• Failing to participate in peer counselor education/training provided for the study

B. Intervention Pregnant women-mothers

• Pregnant women-mothers that indicate before delivery that they will not initiate breastfeeding

C. Control Subjects

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jawaharlal Nehru Medical College

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard J. Derman, MD,

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Shivaprasad S. Goudar, MD, MHPE

Role: STUDY_DIRECTOR

Jawaharlal Nehru Medical College, KLE Academy of Higher Education

Locations

Jawaharlal Nehru Medical College

Belagavi, Karnataka, India

Countries

India

References

Charantimath U, Bellad R, Majantashetti N, Washio Y, Derman R, Kelly PJ, Short V, Chung E, Goudar S. Facilitators and challenges to exclusive breastfeeding in Belagavi District, Karnataka, India. PLoS One. 2020 May 4;15(5):e0231755. doi: 10.1371/journal.pone.0231755. eCollection 2020.

Reference Type: RESULT

PMID: 32365108 (View on PubMed)

Short VL, Bellad RM, Kelly PJ, Washio Y, Ma T, Chang K, Majantashetti NS, Charantimath US, Jaeger FJ, Lalakia P, Goudar SS, Derman R. Feasibility, acceptability, and preliminary impact of an mHealth supported breastfeeding peer counselor intervention in rural India. Int J Gynaecol Obstet. 2022 Jan;156(1):48-54. doi: 10.1002/ijgo.13599. Epub 2021 Feb 20.

Reference Type: RESULT

PMID: 33454986 (View on PubMed)

Ma T, Chang K, Alyusuf A, Bajracharya E, Washio Y, Kelly PJ, Bellad RM, Mahantashetti NS, Charantimath U, Short VL, Lalakia P, Jaeger F, Goudar S, Derman R. Design, Development, and Testing of BEST4Baby, an mHealth Technology to Support Exclusive Breastfeeding in India: Pilot Study. JMIR Form Res. 2022 Sep 8;6(9):e32795. doi: 10.2196/32795.

Reference Type: DERIVED

PMID: 36074546 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: BEST4 Baby Consent--Peer Counselors

View Document

Document Type: Informed Consent Form: BEST4Baby Consent--Participants

View Document

Other Identifiers

17F.517

Identifier Type: -

Identifier Source: org_study_id