Effect of a Mobile Health Intervention on Birth Outcome and Infant Health

NCT06431581 | Recruiting DMC

• 1 other identifier: NHRC 42-2042
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 1

Brief Summary

Globally, neonatal and infant mortality persist as challenging concerns, paralleled by a notable prevalence of low birth weight, preterm birth, and challenges in child growth and development. Some of the factors contributing to these issues include poor maternal health and nutrition, maternal smoking, and insufficient maternal awareness. Despite global efforts to improve maternal, newborn, and child health, adverse birth outcomes remain significant challenges, particularly in low and middle-income countries (LMICs). A noteworthy observation is that not all pregnant women modify their behaviors for their and their baby's health due to lack of social support, fear and insecurity. Recognizing the potential for interventions during pregnancy to positively influence maternal, fetal, and neonatal health, this research underscores the role of Mobile Health (mHealth) technologies in leveraging information and communication technology for health service delivery. Accordingly, the study aims to evaluate the effect of mobile health intervention on birth outcomes and infant health in Nepal. In the initial phase, a qualitative study will be conducted to explore the enablers and barriers of perinatal care and preferences of pregnant women through focus group discussions. These insights will inform the development of user-centered educational videos and tailored m-Health interventions for pregnant women. A two-arm parallel randomized controlled trial will then assess the m-Health intervention's effect on the birth outcomes and infant health of the pregnant women attending the antenatal care clinic of Dhulikhel Hospital. The investigaotors will randomize pregnant women at gestational age 14-22 weeks into either a control group (who will receive standard care along with a control video and reminder phone call for follow-up) or an intervention group (who will receive standard care along with m-health intervention that includes educational video, short message service (SMS) and reminder phone call for follow up). Follow-up will be done from enrollment until the child reaches one year of age, with a focus on evaluating effect of m-Health intervention on birth outcomes (birth weight and gestational age at delivery) and infant health (growth and development of the infant). Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analyzed using STATA 14, contributing valuable insights into the potential effect of m-Health intervention on birth outcomes and infant health.

Conditions

Birth Outcomes; Infant Health

Outcome Measures

Primary Outcomes (2)

• Birth weight

  The birth weight of the newborns delivered from the participants will be measured in grams. The mean birth weight of the newborns in both the intervention group and the control group will be compared.

  1-1.5 years

• Gestational age at delivery

  The gestational age at delivery will be expressed in completed weeks of gestation. The mean gestational age at delivery will be compared between the intervention group and the control group.

  1-1.5 years

Secondary Outcomes (4)

• Knowledge on perinatal care

  6 months

• Weight of the infant

  2-2.5 years

• Height/Length of the infant

  2-2.5 years

• Development of an infant

  2-2.5 years

Study Arms (2)

Intervention group (educational video, SMS and reminder phone call)

EXPERIMENTAL

An intervention group will receive standard care along with m-health intervention that includes tailored educational video, SMS and reminder phone call for follow up

Behavioral: m-Health intervention (educational video, SMS and reminder phone call)

Control Group (standard care, control video and reminder phone call for follow up)

NO INTERVENTION

A control group will receive standard care along with a control video and reminder phone call for follow-up

Interventions

m-Health intervention (educational video, SMS and reminder phone call) BEHAVIORAL

Pregnant women meeting the inclusion criteria and assigned to the intervention group will receive m-health intervention that includes a tailored educational video regarding perinatal care targeting positive birth outcomes and infant health, SMS messages, and reminder phone calls for follow-up

Intervention group (educational video, SMS and reminder phone call)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women of age 18 years and above;
• Pregnant with 14 to 22 weeks of gestation;
• Planned to deliver a child and come for infant's vaccination at Dhulikhel hospital;
• Pregnant women who use smart phone;
• Pregnant women who have plan to stay in Dhulikhel thorough out this study period;
• Can read and understand Nepali language

You may not qualify if:

• Vision impairment and diagnosed learning difficulties

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead

Study Sites (1)

Bhawana Shrestha

Dhulikhel, Bagmati, 45210, Nepal

RECRUITING

Related Publications (6)

• Lassi ZS, Middleton PF, Crowther C, Bhutta ZA. Interventions to Improve Neonatal Health and Later Survival: An Overview of Systematic Reviews. EBioMedicine. 2015 May 31;2(8):985-1000. doi: 10.1016/j.ebiom.2015.05.023. eCollection 2015 Aug.

  PMID: 26425706 BACKGROUND

• Khani Jeihooni A, Mohammadkhah F, Razmjouie F, Harsini PA, Sedghi Jahromi F. Effect of educational intervention based on health belief model on mothers monitoring growth of 6-12 months child with growth disorders. BMC Pediatr. 2022 Sep 23;22(1):561. doi: 10.1186/s12887-022-03593-8.

  PMID: 36151526 BACKGROUND

• Lassi ZS, Mansoor T, Salam RA, Das JK, Bhutta ZA. Essential pre-pregnancy and pregnancy interventions for improved maternal, newborn and child health. Reprod Health. 2014;11 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-11-S1-S2. Epub 2014 Aug 21.

  PMID: 25178042 BACKGROUND

• Taneja S, Chowdhury R, Dhabhai N, Mazumder S, Upadhyay RP, Sharma S, Dewan R, Mittal P, Chellani H, Bahl R, Bhan MK, Bhandari N; Women and Infants Integrated Growth Study (WINGS) Group. Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood on linear growth of infants in the first two years of life, birth outcomes and nutritional status of mothers: study protocol of a factorial, individually randomized controlled trial in India. Trials. 2020 Jan 31;21(1):127. doi: 10.1186/s13063-020-4059-z.

  PMID: 32005294 BACKGROUND

• Toolan M, Barnard K, Lynch M, Maharjan N, Thapa M, Rai N, Lavender T, Larkin M, Caldwell DM, Burden C, Manandhar DS, Merriel A. A systematic review and narrative synthesis of antenatal interventions to improve maternal and neonatal health in Nepal. AJOG Glob Rep. 2022 Feb;2(1):100019. doi: 10.1016/j.xagr.2021.100019.

  PMID: 35252905 BACKGROUND

• Park JJH, Harari O, Siden E, Zoratti M, Dron L, Zannat NE, Lester RT, Thorlund K, Mills EJ. Interventions to improve birth outcomes of pregnant women living in low- and middle-income countries: a systematic review and network meta-analysis. Gates Open Res. 2020 Sep 24;3:1657. doi: 10.12688/gatesopenres.13081.2. eCollection 2019.

  PMID: 33134854 BACKGROUND

Related Links

• Effect of parenting intervention through "Care for Child Development Guideline" on early child development and behaviors: a randomized controlled trial. BMC Pediatr.2022;22(1):690
• Pregnancy and Childbirth - Healthy People 2030 \| health.gov
• Lessons from digital technology-enabled health interventions implemented during the coronavirus pandemic to improve maternal and birth outcomes: a global scoping review. BMC Pregnancy Childbirth. 2023 Mar 20;23(1):195.

MeSH Terms

Interventions

Spermine Synthase

Intervention Hierarchy (Ancestors)

Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Central Study Contacts

Bhawana Shrestha, M.Sc. Nursing

CONTACT

977-9841748266; bhawanakoju@kusms.edu.np

Kunta Devi Pun, PhD

CONTACT

977-9841239826; kunta.devi.pun@kusms.edu.np

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 28, 2024
• Study Start: September 9, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)