Breastfeeding Education Support Tool for Baby

NCT03533725 | Completed DMC

• 1 other identifier: 17F.517
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding

Keywords

Initiation, Exclusivity, Duration

Outcome Measures

Primary Outcomes (3)

• Breastfeeding initiation soon after birth

  Maternal subjects' compliance with the recommendation to initiate breastfeeding soon after delivery

  Ideally within an hour following a normal delivery

• Exclusivity of breastfeeding during the first 6 months following an infant's birth

  Maternal subjects' compliance with the recommendation to provide only breast milk

  First 6 months following an infant's birth

• Breastfeeding continuation (along with supplemental feeding) after an infant reaches 6 months of age

  Maternal subjects' compliance with the recommendation for continued breastfeeding along with supplemental feeding after an infant reaches 6 months of age

  As the study is time-limited, assessment will occur 6-9 months following an infant's birth

Secondary Outcomes (4)

• Usability rating of the mHealth tools by peer counselors post-training

  At the end of counseling education/training (project months 8-9)

• Usability rating of the mHealth tools by peer counselors based on use with mothers

  Once peer counselors complete delivery of services to assigned maternal subjects (by months 22-23 of the project)

• Acceptability rating of BEST4Baby program features by mothers

  3 months post-delivery

• Satisfaction rating of mothers with BEST4Baby counseling and education services as delivered

  6-9 months post-delivery

Study Arms (2)

Intervention group

EXPERIMENTAL

Breastfeeding counseling and education services using mHealth tools

Other: Breastfeeding counseling and education services

Comparative control group

NO INTERVENTION

No intervention, only standard of care

Interventions

Breastfeeding counseling and education services OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Females as study involves an activity only females can perform and only females could be considered peers of mothers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Personal experience with breastfeeding - Residence in an intervention cluster

You may not qualify if:

• \- Failing to participate in peer counselor education/training provided for the study
• B. Intervention Pregnant women-mothers
• 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
• \- Pregnant women-mothers that indicate before delivery that they will not initiate breastfeeding
• C. Control Subjects
• 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
• \- None

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Jawaharlal Nehru Medical College: collaborator

Study Sites (1)

Jawaharlal Nehru Medical College

Belagavi, Karnataka, 590010, India

Location

Related Publications (3)

• 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.

  PMID: 32365108 RESULT

• 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.

  PMID: 33454986 RESULT

• 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.

  PMID: 36074546 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Richard J. Derman, MD,

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Shivaprasad S. Goudar, MD, MHPE

  Jawaharlal Nehru Medical College, KLE Academy of Higher Education

  STUDY DIRECTOR

Study Design

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

Model Details: Intervention group having peer counseling and education and a comparative (control) group having standard of care

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: May 23, 2018
• Study Start: March 11, 2019
• Primary Completion: May 31, 2020
• Study Completion: June 30, 2020
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Estimated availability : within 18 months of study closure.
• Access Criteria: Global health researchers upon request

Locations

IN (1)