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Breastfeeding Education Support Tool for Baby (BEST4Baby)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03533725
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : July 1, 2020
Sponsor:
Collaborator:
Jawaharlal Nehru Medical College
Information provided by (Responsible Party):
Thomas Jefferson University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breastfeeding Other: Breastfeeding counseling and education services Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention group having peer counseling and education and a comparative (control) group having standard of care
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Breastfeeding Education Support Tool for Baby
Actual Study Start Date : March 11, 2019
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : June 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
Breastfeeding counseling and education services using mHealth tools
 Other: Breastfeeding counseling and education services
Breastfeeding counseling and education by educated and trained peer counselors using mHealth tools
No Intervention: Comparative control group
No intervention, only standard of care


Outcome Measures
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Primary Outcome Measures :
  1. Breastfeeding initiation soon after birth [ Time Frame: Ideally within an hour following a normal delivery ]
    Maternal subjects' compliance with the recommendation to initiate breastfeeding soon after delivery

  2. Exclusivity of breastfeeding during the first 6 months following an infant's birth [ Time Frame: First 6 months following an infant's birth ]
    Maternal subjects' compliance with the recommendation to provide only breast milk

  3. Breastfeeding continuation (along with supplemental feeding) after an infant reaches 6 months of age [ Time Frame: As the study is time-limited, assessment will occur 6-9 months following an infant's birth ]
    Maternal subjects' compliance with the recommendation for continued breastfeeding along with supplemental feeding after an infant reaches 6 months of age


Secondary Outcome Measures :
  1. Usability rating of the mHealth tools by peer counselors post-training [ Time Frame: At the end of counseling education/training (project months 8-9) ]

    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.


  2. Usability rating of the mHealth tools by peer counselors based on use with mothers [ Time Frame: Once peer counselors complete delivery of services to assigned maternal subjects (by months 22-23 of the project) ]

    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).


  3. Acceptability rating of BEST4Baby program features by mothers [ Time Frame: 3 months post-delivery ]

    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.


  4. Satisfaction rating of mothers with BEST4Baby counseling and education services as delivered [ Time Frame: 6-9 months post-delivery ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females as study involves an activity only females can perform and only females could be considered peers of mothers
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533725


Locations
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India
Jawaharlal Nehru Medical College
Belgaum, Karnataka, India, 590010
Sponsors and Collaborators
Thomas Jefferson University
Jawaharlal Nehru Medical College
Investigators
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Principal Investigator: Richard J. Derman, MD, Thomas Jefferson University
Study Director: Shivaprasad S. Goudar, MD, MHPE Jawaharlal Nehru Medical College, KLE Academy of Higher Education
More Information
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03533725    
Other Study ID Numbers: 17F.517
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant data for the primary and secondary outcomes are expected to be shared in publications resulting from this pilot study.
Supporting Materials: Study Protocol
Time Frame: Estimated availability : within 18 months of study closure.
Access Criteria: Global health researchers upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Jefferson University:
Initiation, Exclusivity, Duration