Using a mobile app to improve health outcomes for pregnant women
A Dietitian-led Cluster Randomised Controlled Trial on the Effectiveness of mHealth Education on Health Outcomes Among Pregnant Women
This study is testing whether a mobile app can help pregnant women in Malaysia gain a healthier amount of weight and improve their overall health during pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 294 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Universiti Putra Malaysia Academic / other |
| Locations | 3 sites (Seri Kembangan, Selangor and 2 other locations) |
| Trial ID | NCT05377151 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a mobile health (mHealth) intervention aimed at improving gestational weight gain and other health outcomes among pregnant women in Malaysia. It involves a cluster randomized controlled trial with three groups: one receiving mHealth education, another receiving mHealth education plus dietitian consultation, and a control group. The study will assess various outcomes including prenatal knowledge, physical activity, psychosocial well-being, nutritional status, quality of life, and sleep quality over a 9-month period. A total of 294 pregnant women will be recruited from health clinics in East and West Malaysia.
Who should consider this trial
Good fit: Ideal candidates for this study are Malaysian women aged 18-40 who are in their first or second trimester of a single pregnancy.
Not a fit: Patients with major psychiatric problems, multiple pregnancies, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved health outcomes for pregnant women and their babies.
How similar studies have performed: Other studies have shown promise in using mHealth interventions for improving pregnancy outcomes, but this specific approach in Malaysia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Malaysian women * 18 - 40 years old * Single pregnancy * At first trimester or second trimester * All ethnicities * Meet or did not meet with dietitian before * With or without diseases (diabetes mellitus with/ without low dose insulin, hypertension, hyperlipidaemia, overweight/ obese) * Own smart phone with internet access * All BMI categories Exclusion Criteria: * Diagnosed by medical doctor with major psychiatric problems (bipolar depression, schizophrenia, suicidal risk) * Multiple pregnancies * On other intervention program * Grand multipara * Severe comorbidities (cardiac diseases, severe anaemia) * Type 1 diabetes mellitus or Type 2 diabetes mellitus with high dose insulin
Where this trial is running
Seri Kembangan, Selangor and 2 other locations
- Seri Kembangan Health Clinic — Seri Kembangan, Selangor, Malaysia (Recruiting)
- Presint 18 Health Clinic — Putrajaya, Malaysia (Recruiting)
- Presint 9 Health Clinic — Putrajaya, Malaysia (Recruiting)
Study contacts
- Principal investigator: Yoke Mun Chan — Universiti Putra Malaysia
- Study coordinator: Yoke Mun Chan
- Email: cym@upm.edu.my
- Phone: 03-97692433
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.