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Development and Pilot Test of a Postnatal mHealth Intervention - Phase 2

Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 2

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04693585
Acronym
MESSAGE
Enrollment
201
Registered
2021-01-05
Start date
2021-07-30
Completion date
2022-11-15
Last updated
2024-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acceptability of Health Care, Health Attitude, Knowledge, Attitudes, Practice, Post Partum Depression

Brief summary

The goal of the study is to assess the feasibility and acceptability of the optimized MeSSSSage intervention which was developed and revised based on the results of our initial pilot testing. The investigators will conduct a controlled 4-arm factorial design randomized study to test the feasibility, acceptability and preliminary effectiveness of several intervention modalities over a 6-month period.

Detailed description

Most mHealth interventions for maternal and child health (MCH) in low and middle-income countries, including India, have focused on unidirectional and non-interactive approaches, primarily text messaging. However, ample evidence suggests that provider-led, interactive educational programming and social support are key for improving health behaviors and outcomes. Thus innovative mHealth approaches that promote interactive education and facilitate social support have great potential to improve MCH outcomes. The two-phase development of MeSSSSage include sPhase 1: exploratory development on functions and platforms and Phase 2: a mixed-methods randomized pilot study using a factorial design of specific intervention functions and platforms confirmed in Phase 1. Study activities described herein are associated with Phase 1. The study's specific aim is: To test the optimized intervention to understand the feasibility, acceptability and preliminary effectiveness of several intervention modalities among postnatal women in rural India. In Phase 2, the investigators conduct a randomized factorial design to understand the contribution to various intervention modalities on feasibility, accessibility and preliminary effectiveness. Data are collected via quantitative participant survey (baseline and endline) including sociodemographic characteristics and knowledge about maternal and infant health, self-efficacy, and perceived social norms regarding MCH-related health promoting behaviors (baseline) acceptability questions such as women's satisfaction with and perceptions of MeSSSSage, maternal and infant knowledge-, behavior-, and health-related questions including about breastfeeding, complementary food introduction, immunization, family planning uptake, maternal physical and mental health, etc. The investigators will validate self-report with health records. The investigators will conduct in-depth interviews among a purposive sample of 30 women to understand: mobile technology familiarity prior to intervention, perspectives on intervention and challenges, structure of intervention (group, individual), content, perspectives on the text-based component, relationship with other participants, perspective on the moderator, postnatal period health related concerns, sources of support (social and informational), recommendations. Other assessment will include technological data from, and group moderator surveys and interviews.

Interventions

BEHAVIORALMESSSSAGE - live

mHealth education and social support intervention, synchronous via call

BEHAVIORALMESSSSAGE - asynchronous

mHealth education and social support intervention, asynchronous via text

Sponsors

University of California, Los Angeles
CollaboratorOTHER
Post Graduate Institute of Medical Education and Research, Chandigarh
CollaboratorOTHER
Indraprastha Institute of Information Technology Delhi
CollaboratorOTHER
Survival for Women and Children Foundation
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

The three intervention modalities to be tested include: real-time live voice calls versus audio/video recording; text-based, asynchronous, on-demand social support; and standard of postnatal care (3 visits in first 7 days).

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Postnatal (within 2 weeks) * 18+ years old

Exclusion criteria

* Women below 18 years of age * Women with high risk pregnancies * Women who delivered preterm, suffer severe maternal complications or they or their baby are otherwise sick in the first week

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience6 monthsNumber of participants reporting being satisfied or very satisfied with their overall intervention experience, assessed through a five-point Likert scale at six months.
Number of Participants Engaging in Group Call Intervention6 monthsNumber of participants who engaged in weekly group call intervention activities by 6 months

Secondary

MeasureTime frameDescription
Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.6 monthsNumber of participants correctly identifying at least 80% of knowledge on maternal and neonatal danger signs, best practices for infant care, and family planning at 6 months.
Number of Participants Exclusively Breastfeeding6 monthsNumber of participants who exclusively breastfed their infants through 6 months of age
Number of Participants Reporting Postpartum Depression6 monthsNumber of participants reporting postpartum depression symptoms at six months
Number of Participants Who Adopted Postpartum Family Planning6 monthsNumber of participants who started a modern contraceptive methods within 6 months postpartum

Countries

India

Participant flow

Participants by arm

ArmCount
Arm 1: Synchronous and Asynchronous Support
Synchronous: Real-time live voice or video call Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
120
Arm 2: Asynchronous Support
Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
40
Arm 3: Control
Other: Standard of postnatal care.
41
Total201

Baseline characteristics

CharacteristicArm 1: Synchronous and Asynchronous SupportArm 2: Asynchronous SupportArm 3: ControlTotal
Age, Continuous26.7 years
STANDARD_DEVIATION 3.7
26.1 years
STANDARD_DEVIATION 3.4
26.8 years
STANDARD_DEVIATION 4.9
26.6 years
STANDARD_DEVIATION 3.9
Race/Ethnicity, Customized
Indian
120 Participants40 Participants41 Participants201 Participants
Region of Enrollment
India
120 participants40 participants41 participants201 participants
Sex: Female, Male
Female
120 Participants40 Participants41 Participants201 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 940 / 280 / 13
other
Total, other adverse events
0 / 940 / 280 / 13
serious
Total, serious adverse events
0 / 940 / 280 / 13

Outcome results

Primary

Number of Participants Engaging in Group Call Intervention

Number of participants who engaged in weekly group call intervention activities by 6 months

Time frame: 6 months

Population: Group call intervention activities only relevant to arm 1.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1: Synchronous and Asynchronous SupportNumber of Participants Engaging in Group Call Intervention37 Participants
Primary

Number of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience

Number of participants reporting being satisfied or very satisfied with their overall intervention experience, assessed through a five-point Likert scale at six months.

Time frame: 6 months

Population: Control group participants did not answer questions about intervention experience

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1: Synchronous and Asynchronous SupportNumber of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience90 Participants
Arm 2: Asynchronous SupportNumber of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience19 Participants
Secondary

Number of Participants Exclusively Breastfeeding

Number of participants who exclusively breastfed their infants through 6 months of age

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1: Synchronous and Asynchronous SupportNumber of Participants Exclusively Breastfeeding79 Participants
Arm 2: Asynchronous SupportNumber of Participants Exclusively Breastfeeding18 Participants
Arm 3: ControlNumber of Participants Exclusively Breastfeeding11 Participants
Secondary

Number of Participants Reporting Postpartum Depression

Number of participants reporting postpartum depression symptoms at six months

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1: Synchronous and Asynchronous SupportNumber of Participants Reporting Postpartum Depression43 Participants
Arm 2: Asynchronous SupportNumber of Participants Reporting Postpartum Depression10 Participants
Arm 3: ControlNumber of Participants Reporting Postpartum Depression5 Participants
Secondary

Number of Participants Who Adopted Postpartum Family Planning

Number of participants who started a modern contraceptive methods within 6 months postpartum

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1: Synchronous and Asynchronous SupportNumber of Participants Who Adopted Postpartum Family Planning67 Participants
Arm 2: Asynchronous SupportNumber of Participants Who Adopted Postpartum Family Planning14 Participants
Arm 3: ControlNumber of Participants Who Adopted Postpartum Family Planning10 Participants
Secondary

Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.

Number of participants correctly identifying at least 80% of knowledge on maternal and neonatal danger signs, best practices for infant care, and family planning at 6 months.

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1: Synchronous and Asynchronous SupportNumber of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.0 Participants
Arm 2: Asynchronous SupportNumber of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.0 Participants
Arm 3: ControlNumber of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026