About this trial
The goal of this study is to assess the effectiveness of a culturally-tailored mobile interactive education and support group intervention to supplement standard postpartum care activities in comparison to standard care alone on health-related behaviors and health outcomes in a randomized controlled trial among 2100 postpartum Indian women living in 3 geographically diverse Indian states to estimate the impact on maternal and neonatal health-related knowledge, health-related behaviors, and health outcomes. The investigators also seek to characterize mechanisms of impact including knowledge, social support, self-efficacy, and behavior change, and determine the cost-effectiveness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant (28-32 weeks gestational age)
Speak local language
Personal mobile phone or willing to accept study phone
Able to provide informed consent
Disqualifiers
Do not speak local language
No personal phone or unwilling to accept study phone
Unable to provide informed consent
Trial design
Parallel
Treatments tested in this trial
MESSSSAGE intervention
Behavioralgroup mHealth education and social support intervention
Treatment groups
Trial outcomes
Primary outcomes
Exclusive breastfeeding
Proportion of participants reporting exclusive breastfeeding at 3 and 6 months
Postpartum depression
Proportion of participants reporting postpartum depression symptoms at 3 and 6 months
Postpartum family planning adoption
Proportion of participants not wanting to become pregnant immediately having started a modern contraceptive method within 6 months postpartum
Secondary outcomes
Maternal and neonatal danger sign knowledge
Proportion of participants correctly identifying all maternal and neonatal danger signs by 6 months
Maternal and neonatal health care use
Proportion of participants seeking healthcare for maternal and neonatal concerns within 6 months
Neonatal preventive health care use
Proportion of participants having achieved target neonatal preventive care visits within 6 months
Infant vaccination
Proportion of participants having achieved recommended childhood vaccination schedule by 6 months
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Collaborator
Indraprastha Institute of Information Technology Delhi
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Sangath
Collaborator