mHealth India Postnatal Health Intervention Effectiveness

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorUniversity of California, San Francisco

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • MESSSSAGE intervention

    Behavioral

    group mHealth education and social support intervention

Treatment groups

2,100 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Exclusive breastfeeding

Proportion of participants reporting exclusive breastfeeding at 3 and 6 months

Time frame
6 months
2

Postpartum depression

Proportion of participants reporting postpartum depression symptoms at 3 and 6 months

Time frame
6 months
3

Postpartum family planning adoption

Proportion of participants not wanting to become pregnant immediately having started a modern contraceptive method within 6 months postpartum

Time frame
6 months

Secondary outcomes

1

Maternal and neonatal danger sign knowledge

Proportion of participants correctly identifying all maternal and neonatal danger signs by 6 months

Time frame
6 months
2

Maternal and neonatal health care use

Proportion of participants seeking healthcare for maternal and neonatal concerns within 6 months

Time frame
6 months
3

Neonatal preventive health care use

Proportion of participants having achieved target neonatal preventive care visits within 6 months

Time frame
6 months
4

Infant vaccination

Proportion of participants having achieved recommended childhood vaccination schedule by 6 months

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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