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Completed

NCT Number: NCT03533725

Breastfeeding Education Support Tool for Baby

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jawaharlal Nehru Medical College

Belagavi, Karnataka, 590010, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breastfeeding counseling and education services

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Jawaharlal Nehru Medical College

Registry information

Acronym: BEST4Baby

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 23, 2018
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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