Effectiveness of mHealth Education on Health Outcomes Among Pregnant Women
A Dietitian-led Cluster Randomised Controlled Trial on the Effectiveness of mHealth Education on Health Outcomes Among Pregnant Women
1 other identifier
interventional
294
1 country
3
Brief Summary
Gestational weight gain (GWG), weight gain of a mother during pregnancy, is an important determinant that influence the health outcomes of mothers and fetus. There is an increasing trend of pregnant women using mobile health (mHealth) to assess for pregnancy-related health information. While evidence on the effectiveness of mHealth education on improving pregnancy outcomes among pregnant women is growing, the findings had been inconclusive with scarcity of such data in Malaysia. The objective of the study is to determine the effectiveness of a 9-month mHealth intervention on GWG and other outcomes (prenatal knowledge, physical activity, psychosocial well-being, nutritional status, quality of life and sleep quality) among pregnant women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2022
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedSeptember 15, 2023
September 1, 2023
6 months
April 24, 2022
September 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Gestational Weight Gain
Weight gain (kg)
3 points time (Baseline, 6th month, 9th month/ delivery)
Secondary Outcomes (16)
Prenatal knowledge
1 point1 time (Baseline)
Physical activity
2 points time (Baseline, 6th month)
Psychosocial well-being
3 points time (Baseline, 6th month, 9th month/ delivery)
Nutritional status
3 points time (Baseline, 6th month, 9th month/ delivery)
Quality of life (well being)
3 points time (Baseline, 6th month, 9th month/ delivery)
- +11 more secondary outcomes
Study Arms (3)
mobile application (mHealth) intervention only
EXPERIMENTAL\- the subjects will receive mobile application (mHealth) intervention only
mobile application (mHealth) intervention and dietitian consultation
EXPERIMENTAL\- the subjects will receive the information from both mobile application (mHealth) and dietitian consultation
standard usual care- dietitian consultation
NO INTERVENTION\- the subjects will receive all the related information from the standard usual care- dietitian consultation
Interventions
Nutrition intervention using either mHealth interventions or conventional methods will be carried out among pregnant women). Subjects will be allocated into three groups, namely, two interventions group which are: Group 1: mHealth intervention group (98 subjects) Group 2: mHealth intervention group + dietitian consultation (98 subjects) Group 3: control group (98 subjects)
Eligibility Criteria
You may qualify if:
- Malaysian women
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Seri Kembangan Health Clinic
Seri Kembangan, Selangor, 43300, Malaysia
Presint 18 Health Clinic
Putrajaya, Malaysia
Presint 9 Health Clinic
Putrajaya, Malaysia
Related Publications (1)
Er YT, Chan YM, Mohd Shariff Z, Abdul Hamid H, Mat Daud Z', Yong HY. Dietitian-led cluster randomised controlled trial on the effectiveness of mHealth education on health outcomes among pregnant women: a protocol paper. BMJ Open. 2023 Nov 20;13(11):e075937. doi: 10.1136/bmjopen-2023-075937.
PMID: 37989361DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoke Mun Chan
Universiti Putra Malaysia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 24, 2022
First Posted
May 17, 2022
Study Start
April 1, 2023
Primary Completion
September 30, 2023
Study Completion
June 30, 2024
Last Updated
September 15, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share