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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR021403 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| University of Michigan | OTHER |
| Kamuzu University of Health Sciences | OTHER |
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The proposed study will evaluate the effectiveness of an integrated group postpartum and well-child care model, compared to individual (usual) postnatal and well-child care, on maternal and child health outcomes. Results will provide clinical evidence for improved maternal and infant health care in the first year postpartum. The study will inform and provide lessons learned to advance maternal and infant health service delivery models in low resource settings.
A cluster randomized controlled trial design with mixed methods will be used to determine the impact and comparative effectiveness of group versus usual individual care with postpartum women and the women's infants in 16 clinics across Zomba District, Malawi. Data is collected at baseline, 6- and 12-months. Women are nested within the postpartum/well-child care group for the intervention. In the control arm, dyads will be grouped based on order of entry within each site. The first 10 dyads will form "group" 1, the second 10 dyads "group" 2, etc. The investigators will also explore the health and health-related social needs that arise in the 12 months after birth for both women and the women's infants through in-depth interviews as well as implementation barriers and facilitators for group postpartum and well-child care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Care | Experimental |
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| Usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Care | Behavioral | Group care in the postpartum period brings the same group of 8-10 women and their infants, born within one month of one another, together for one year of integrated healthcare for the dyad. Sessions are co-facilitated by a midwife and HSA. Each session is 120 minutes: first 30-45 minutes consist of self-assessments (measuring infant's weight/length, taking own vital signs) and standard health assessments by a clinician; health concerns are identified/managed and referrals made if needed. Followed by 75-90 minutes of interactive health promotion, skills-building, and support activities. 6-visit model aligned with Malawian vaccine schedule: 6 weeks, 10 weeks, 14 weeks, 6 months, 9 months, and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Postpartum depression score as measured by the Edinburgh Postnatal Depression Scale (EPDS) | The EPDS is a 10-item self-report scale with scores ranging from 0-30; higher scores indicate more depressive symptoms. | baseline, 6 months, and 12 months postpartum |
| Infant immunization completion rate per national immunization schedule | 6 months, and 12 months after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants using a family planning method | baseline, 6 months and 12 months postpartum | |
| Number of Participants who recall postnatal care content as measured by structured survey | 6 and 12 months postpartum |
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Inclusion Criteria:
Aims 1&2:
Aim 3:
Exclusion Criteria:
Aim 1&2
Aim 3
-Serious physical or mental illness or marked cognitive impairment preventing informed consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Gresh | Contact | 603-831-3942 | ashley.gresh@jhu.edu | |
| Ellen Chirwa | Contact | +265888940513 | embweza@kuhes.ac.mw |
| Name | Affiliation | Role |
|---|---|---|
| Ashley Gresh | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bimbi HC | Not yet recruiting | Zomba | Malawi |
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| Self-reported peer connectedness as measured by study survey | Peer connectedness assessed via a 14-item survey. Total score range: 0-56. Higher scores indicate greater peer connectedness. | 6 and 12 months postpartum |
| Breastfeeding self-efficacy as measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) | The BSES-SF is a 14-item self-report scale with a total score range of 14-70. Higher scores indicate greater breastfeeding self-efficacy. | baseline, 6 months and 12 months postpartum |
| Number of Participants Exclusively breastfeeding at 6 months after birth | 6 months postpartum |
| Partner communication as measured by relationship quality survey | 2-item survey with total score range 0-2. Higher scores indicate higher relationship quality. | baseline, 6 months, and 12 months postpartum |
| Maternal nutrition as measured by dietary diversity survey | Dietary diversity assessed via 6-item 24-hour recall with a total score range of 0-6. Higher scores indicate greater dietary diversity. | baseline, 6 months, and 12 months postpartum |
| Maternal anemia - hemoglobin level measured by point-of-care bloodspot test | baseline and 12 months postpartum |
| Hypertension as measured by blood pressure assessment | Hypertension assessed by systolic and diastolic blood pressure measurement in mmHg. Hypertension defined as systolic ≥140 mmHg and/or diastolic ≥90 mmHg per WHO guidelines. | baseline, 6 months, and 12 months postpartum |
| Postpartum anxiety as measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7) | Anxiety symptoms assessed using the GAD-7, a 7-item self-report scale with a total score range of 0-21. Higher scores indicate greater anxiety. | baseline, 6 months, and 12 months postpartum |
| Maternal mortality as measured by clinic reporting | 6 months and 12 months postpartum |
| Infant growth as measured by weight-for-age per growth standards | baseline, 6 months, and 12 months after birth |
| Infant growth as measured by length-for-age per growth standards | baseline, 6 months, 12 months after birth |
| Infant nutritional status as measured by mid-upper arm circumference (MUAC) | 6 months and 12 months after birth |
| Infant anemia as measured by point-of-care hemoglobin bloodspot test | 12 months after birth |
| Child development as measured by the Malawi Developmental Assessment Tool (MDAT) | Child development assessed using the MDAT, a tool measuring four domains: gross motor, fine motor, language, and social development. Each domain is scored 0-34 based on passed items. Total score range: 0-136. Higher scores indicate more advanced development. | 6 months and 12 months after birth |
| Infant mortality as measured by clinic reporting and parent's self-report | 6 months and 12 months after birth |
| Chamba HC | Recruiting | Zomba | Malawi |
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| Chingale HC | Not yet recruiting | Zomba | Malawi |
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| Domasi HC | Not yet recruiting | Zomba | Malawi |
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| Lambulira HC | Recruiting | Zomba | Malawi |
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| Likangala HC | Recruiting | Zomba | Malawi |
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| M'mambo HC | Not yet recruiting | Zomba | Malawi |
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| Machinjiri HC | Recruiting | Zomba | Malawi |
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| Maera HC | Not yet recruiting | Zomba | Malawi |
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| Makwapala | Recruiting | Zomba | Malawi |
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| Matawale HC | Recruiting | Zomba | Malawi |
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| Mwandama HC | Not yet recruiting | Zomba | Malawi |
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| Naisi HC | Recruiting | Zomba | Malawi |
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| Namasalima HC | Recruiting | Zomba | Malawi |
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| Nasawa | Not yet recruiting | Zomba | Malawi |
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| Ngwelero HC | Not yet recruiting | Zomba | Malawi |
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