Clinical trial NCT03533725: Breastfeeding Education Support Tool for Baby
Official title: Breastfeeding Education Support Tool for Baby
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Initiation, Exclusivity, Duration
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Jawaharlal Nehru Medical College
First posted: 2018-05-23
Enrollment: 247
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group having peer counseling and education and a comparative (control) group having standard of care
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: A. Peer counselors

Inclusion Criteria:

Personal experience with breastfeeding - Residence in an intervention cluster

Exclusion Criteria:

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

B. Intervention Pregnant women-mothers

Inclusion Criteria:

* 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

Exclusion Criteria:

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

C. Control Subjects

Inclusion Criteria:

* 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:

- None

Primary outcomes:
measure: Breastfeeding initiation soon after birth
timeFrame: Ideally within an hour following a normal delivery
measure: Exclusivity of breastfeeding during the first 6 months following an infant's birth
timeFrame: First 6 months following an infant's birth
measure: Breastfeeding continuation (along with supplemental feeding) after an infant reaches 6 months of age
timeFrame: As the study is time-limited, assessment will occur 6-9 months following an infant's birth
Secondary outcomes:
measure: Usability rating of the mHealth tools by peer counselors post-training
timeFrame: At the end of counseling education/training (project months 8-9)
measure: Usability rating of the mHealth tools by peer counselors based on use with mothers
timeFrame: Once peer counselors complete delivery of services to assigned maternal subjects (by months 22-23 of the project)
measure: Acceptability rating of BEST4Baby program features by mothers
timeFrame: 3 months post-delivery
measure: Satisfaction rating of mothers with BEST4Baby counseling and education services as delivered
timeFrame: 6-9 months post-delivery
Other outcomes:
Locations:
city: Belgaum
country: India
facility: Jawaharlal Nehru Medical College
state: Karnataka
Study officials:
affiliation: Thomas Jefferson University
name: Richard J. Derman, MD,
role: PRINCIPAL_INVESTIGATOR
affiliation: Jawaharlal Nehru Medical College, KLE Academy of Higher Education
name: Shivaprasad S. Goudar, MD, MHPE
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.