Breastfeeding Education Support Tool for Baby

Study Overview
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Brief Summary
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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
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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.

Official Title
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Breastfeeding Education Support Tool for Baby

Conditions
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Breastfeeding

Intervention / Treatment
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* Other: Breastfeeding counseling and education services


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group having peer counseling and education and a comparative (control) group having standard of care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Breastfeeding counseling and education services using mHealth tools | Other: Breastfeeding counseling and education services<br>* Breastfeeding counseling and education by educated and trained peer counselors using mHealth tools<br>|
| No Intervention: Comparative control group<br>No intervention, only standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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). | 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 | 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. | 3 months post-delivery | 
| 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. | 6-9 months post-delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Initiation, Exclusivity, Duration