Breastfeeding Clinical Trial
— ECEMTZOfficial title:
Essential Coaching for Every Mother: Developing and Evaluating a Text Message Postnatal Education Intervention for Mothers of Newborns in Tanzania
NCT number | NCT05362305 |
Other study ID # | ECEMTZ |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | January 2025 |
The purpose of this study is to evaluate a text message intervention called Essential Coaching for Every Mother in Tanzania to improve mothers' access to essential newborn care information during the immediate six-week postnatal period.
Status | Not yet recruiting |
Enrollment | 180 |
Est. completion date | January 2025 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - have recently given birth within the hospital - have daily access to a mobile phone with text message capabilities - are over 18 years of age - speak and read English or Swahili. Exclusion Criteria: - newborns die or are expected to die prior to leaving the hospital - they have no access to mobile phone, either personal or shared - unwilling to receive text messages - decline to participate - are experiencing major postnatal complications expected to impact learning or ability to consent while in the hospital (e.g., postpartum hemorrhage, seizures) - participated in Phase I of this project. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
IWK Health Centre |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment Effectiveness | Number of participants enrolled versus approached. Number of participants per hospital site. | Enrolment | |
Primary | Implementation Dose | Dose delivered - number of text messages sent. Output data available through the Africa's Talking and TextIt platforms will be collected per participant. | Enrolment and study completion (6 weeks) | |
Primary | Implementation Engagement | Un-subscription rates/drop out after enrolment. Output data available through the Africa's Talking and TextIt platforms will be collected per participant. | Enrolment and study completion (6 weeks) | |
Primary | Implementation Quality | Mothers in the intervention group will be asked about the number of messages they recall receiving, user experience, perspectives on the frequency and timing of messages, and what did they like and not like about Essential Coaching for Every Mother. | Six-weeks postpartum | |
Secondary | Newborn Care Knowledge | Knowledge will be assessed using a modified questionnaire developed by McConnell and colleagues. Questions will determine whether mothers can identify danger signs, hand washing practices, cord care, newborn thermal care, and breastfeeding. A summative score will be created with a maximum of five points and a minimum of zero, where each point represents knowledge on the above postnatal health topics. | Baseline (enrolment), and six-weeks postpartum (follow-up) | |
Secondary | Maternal Self-Efficacy | Parenting self-efficacy will be measured using the Karitane Parenting Confidence Scale (KPCS) tool. This 15-item tool was developed to assess perceived self-efficacy of mothers of newborns birth to twelve months of age. A cut off score of 39 or less (out of a possible 45) was determine to be a clinically low perceived parenting self-efficacy (PPSE). | Baseline (enrolment), and six-weeks postpartum (follow-up) | |
Secondary | Breastfeeding Self-Efficacy | Breastfeeding self-efficacy will be measured using the Breastfeeding Self-Efficacy Scale - Short Form. Higher scores indicate higher breastfeeding self-efficacy. | Baseline (enrolment), and six-weeks postpartum (follow-up) | |
Secondary | Postpartum Depression | Depression will be measured using the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a self-report screening scale with 10 items that can indicate if a respondent has symptoms related to perinatal depression with a score >12 considered high symptoms of depression. | Baseline (enrolment), and six-weeks postpartum (follow-up) | |
Secondary | Postpartum Anxiety | Anxiety will be measured using the Generalized Anxiety Disorder (GAD)-7, which is a 7-item scale used to assess generalized anxiety disorder. The scale ranges between 0 and 21, with scores of 10 or greater indicative of generalized anxiety at a moderate/severe level. | Baseline (enrolment), and six-weeks postpartum (follow-up) | |
Secondary | Newborn morbidity | Data will be collected on number of morbidities (e.g., diarrhea, jaundice, infection) identified per infant enrolled in the study within the 6-weeks. | Six-weeks postpartum (follow-up) | |
Secondary | Newborn mortality | Data will be collected on newborn mortality (e.g., number of infant deaths during study). | Six-weeks postpartum (follow-up) | |
Secondary | Need for readmission | Data will be collected on number of readmission to hospital for the infant and mothers during the six weeks and related reason. | Six-weeks postpartum (follow-up) | |
Secondary | Postnatal Clinic Attendance | Data will be collected on the number and date of postnatal contact. | Six-weeks postpartum (follow-up) |
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