Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
360

Summary

Conditions
Pregnancy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

A parallel group randomized controlled trial will be implemented with pregnant women at the antenatal clinics of the Aga Khan University Hospital (AKUH) Karachi. Pregnant women in their first trimester, registered or planning to register at AKUH with access to smartphones with internet connection wi...

A parallel group randomized controlled trial will be implemented with pregnant women at the antenatal clinics of the Aga Khan University Hospital (AKUH) Karachi. Pregnant women in their first trimester, registered or planning to register at AKUH with access to smartphones with internet connection will be considered eligible for the study. For pregnant women in the intervention arm, mobile health application will be provided in their smartphones that will screen on their socio-demographic characteristics, diet and supplement use and lifestyle habits. Based on the data gathered, recommendations and a dietary risk score will be generated upon completion of the screening questionnaire. The similar process will be repeated on 4 follow-ups, each 6 weeks apart after enrollment in the study. Also, push notifications will be sent to women maximum 3 times a week on dietary and lifestyle advice. The women in the control arm will be provided with standard counseling using the educational pamphlet of the Aga Khan University Hospital "Diet during Pregnancy". The primary outcome of the study is improvement in the dietary and supplement use that will be assessed through Dietary Risk Score. The secondary outcomes include assessing the compliance and usability of m-Health application among the pregnant women enrolled in the intervention arm. Other secondary outcomes include evaluating the effect of m-Health coaching on maternal, fetal and infant outcomes among pregnant women and infant born to women in the intervention arm compared to women and infants born to women who received standard counseling respectively.

Tracking Information

NCT #
NCT04216446
Collaborators
Not Provided
Investigators
Principal Investigator: Rozina Nuruddin Assistant Professor