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BreastfeedingBEST4BabyNCT03533725

Breastfeeding Education Support Tool for Baby

A study testing Breastfeeding counseling and education services in people with Breastfeeding, run by Thomas Jefferson University at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breastfeeding
What is being tested?
Breastfeeding counseling and education services
Could I receive a placebo?
No, everyone receives an active treatment
How many people
247 participants
Where
1 siteIndia
Study dates
11 Mar 2019to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site

  • Jawaharlal Nehru Medical College

    Belagavi, Karnataka, 590010

Other trials in India

About this study

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.

Read the 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
Being tested
Breastfeeding counseling and education services
Keywords
Initiation, Exclusivity, Duration
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breastfeeding counseling and education servicesOther

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

Study groups in NCT03533725
Study groupRoleWhat they receive
Intervention groupExperimentalBreastfeeding counseling and education services using mHealth tools
Receives: Other: Breastfeeding counseling and education services
Comparative control groupNo interventionNo intervention, only standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breastfeeding initiation soon after birth

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

    Measured: Ideally within an hour following a normal delivery

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

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

    Measured: First 6 months following an infant's birth

  3. 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

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

Secondary outcomes (4)

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

    Peer counselors will complete a scale, mHealth Tools Usability Scale for Peer Counselors

    Information relevant to this scale:

    Likert scale with 10 statements associated with usability: 5 positive and 5 negative

    Range of responses 1. Strongly Disagree, 2. Disagree, 3. Neutral/No Opinion, 4. Agree, 5. Strongly Agree

    Scoring: For positive items, the score contribution is the scale position number minus 1; and for negative items the contribution is 5 minus the scale position number. All scores are totaled and multiplied by 2.5, resulting in a total score per subject of 0-100. With this scoring method the higher the score, the greater is usability of the mHealth tools as perceived by the peer counselors after training but before actual use with mothers.

    Scale is based upon one initially developed and tested by Digital Equipment Corporation; items have been slightly modified to achieve a better match with the BEST4Baby pilot.

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

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

    Peer counselors will complete a scale, mHealth Tools Usability Scale for Peer Counselors Based Upon Use with Mothers

    Information relevant to the scale:

    Likert Scale with 10 statements associated with usability: 5 positive and 5 negative

    Range of responses 1. Strongly Disagree, 2. Disagree, 3. Neutral/No Opinion, 4. Agree, 5. Strongly Agree

    Scoring: For positive items, the score contribution is the scale position number minus 1; and for negative items the contribution is 5 minus the scale position number. All scores are totaled and multiplied by 2.5, resulting in a total score per subject of 0-100. With this scoring method the higher the score, the greater is usability of the mHealth tools.as perceived by peer counselors based upon use with the mothers.

    The scale is similar to the one for Secondary Outcome Measure 4 (and is similar to the referenced Digital Equipment Corporation scale).

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

  3. Acceptability rating of BEST4Baby program features by mothers

    Maternal subjects will utilize a scale, Mothers Acceptability Rating Scale for BEST4Baby Program Features

    Information relevant to this scale:

    Likert Scale with 10 statements associated with features of the BEST4Baby program: 5 positive and 5 negative (related to peer counselor, home visits, educational modality, etc.)

    Range of responses 1. Very unacceptable, 2. Unacceptable, 3. Neutral/No Opinion, 4. Acceptable, 5. Very Acceptable

    Scoring: For positive items, the score contribution is the scale position number minus 1; and for negative items the contribution is 5 minus the scale position number. All scores are totaled and multiplied by 2.5, resulting in a total score per subject of 0-100. With this scoring method the higher the score, the more acceptable were program features to the maternal subject.

    Measured: 3 months post-delivery

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

    Maternal subjects will complete a scale, Mothers Level of Satisfaction with BEST4Baby Services as Delivered

    Information relevant to this scale:

    Likert Scale with 10 statements associated with level of satisfaction with BEST4Baby counseling and education services as delivered: 5 positive and 5 negative

    Range of responses 1. Very unsatisfied, 2. Unsatisfied, 3. Neutral/No Opinion, 4. Satisfied, 5. Very Satisfied

    Scoring: For positive items, the score contribution is the scale position number minus 1; and for negative items the contribution is 5 minus the scale position number. All scores are totaled and multiplied by 2.5, resulting in a total score per subject of 0-100. With this scoring method the higher the score, the more satisfied the subject was with the counseling and education services as delivered.

    Measured: 6-9 months post-delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2018
  2. Study start11 Mar 2019
  3. Primary completion31 May 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Intervention group having peer counseling and education and a comparative (control) group having standard of care
Masking
None (open label)
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03533725
Sponsor's protocol ID
17F.517
Acronym
BEST4Baby
Status last verified
May 2022
First submitted
10 May 2018
Last updated
31 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified participant data for the primary and secondary outcomes are expected to be shared in publications resulting from this pilot study.

Publications

  • 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.

    PubMed 32365108

  • 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.

    PubMed 33454986

  • 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.

    PubMed 36074546

Questions about this trial

What is this clinical trial studying?

A study testing Breastfeeding counseling and education services in people with Breastfeeding, run by Thomas Jefferson University at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breastfeeding initiation soon after birth (time frame: Ideally within an hour following a normal delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03533725, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.

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