Breastfeeding Education Support Tool for Baby
- Conditions
- Breastfeeding
- Interventions
- Other: Breastfeeding counseling and education services
- Registration Number
- NCT03533725
- Lead Sponsor
- Thomas Jefferson University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 247
Personal experience with breastfeeding - Residence in an intervention cluster
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Breastfeeding counseling and education services Breastfeeding counseling and education services using mHealth tools
- Primary Outcome Measures
Name Time Method Breastfeeding initiation soon after birth Ideally within an hour following a normal delivery Maternal subjects' compliance with the recommendation to initiate breastfeeding soon after delivery
Exclusivity of breastfeeding during the first 6 months following an infant's birth First 6 months following an infant's birth Maternal subjects' compliance with the recommendation to provide only breast milk
Breastfeeding continuation (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 Maternal subjects' compliance with the recommendation for continued breastfeeding along with supplemental feeding after an infant reaches 6 months of age
- Secondary Outcome Measures
Name Time Method Usability rating of the mHealth tools by peer counselors post-training 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.Usability rating of the mHealth tools by peer counselors based on use with mothers 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).Acceptability rating of BEST4Baby program features by mothers 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.Satisfaction rating of mothers with BEST4Baby counseling and education services as delivered 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.
Trial Locations
- Locations (1)
Jawaharlal Nehru Medical College
🇮🇳Belgaum, Karnataka, India