Optimizing Gestational Weight Gain for Prevention of Gestational Diabetes Mellitus in Malaysia
NCT ID: NCT05489536
Last Updated: 2022-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20000 participants
INTERVENTIONAL
2023-01-01
2023-12-31
Brief Summary
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Detailed Description
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Specific objectives:
1. To compare changes in the primary outcome (incidence of GDM) between pregnant mothers receiving web/smartphone-based lifestyle program (i.e. intervention group) and pregnant mothers not receiving web/smartphone-based lifestyle program (i.e. control group).
2. To compare changes in the secondary outcomes (GWG, dietary intake and physical activity) between pregnant mothers receiving web/smartphone-based lifestyle program (i.e. intervention group) and pregnant mothers not receiving web/smartphone-based lifestyle program (i.e. control group).
Study location: A total of nine (9) states are randomly selected to represent the Northern, Southern, East Coast and central regions of Peninsular Malaysia. The states are then randomly assigned to either the intervention states or control states. All maternal and child health (MCH) clinics in the top five highest populated districts are purposively selected.
Study design: This is a cluster-randomized, controlled trial (RCT), whereby states as clusters and will be randomly allocated into either intervention or control group. All pregnant women in each cluster will be included in the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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A Web/smartphone-based Lifestyle Program Intervention Group
As this study is designed specifically to isolate the effect of introducing the web/app into the existing care pathway, the intervention group will receive standard prenatal care provided by health clinics and the web/smartphone app.
A web/smartphone-based lifestyle program package
There are two platforms for the lifestyle program, namely Health and Nutrition Education (HNE) website and HNE app. The participants are requested to download and register on the HNE website and the HNE app. The HNE app is Android and IOS compatible. Both the HNE website and app are designed to support self-directed learning and independently monitor their GWG and dietary intake during pregnancy. Both the HNE website and app will be passcode protected throughout the study period such that access is restricted to only participants in the intervention group.
The web/smartphone-based lifestyle program package consists of:
I. Health and Nutrition Education (HNE) resources II. Gestational Weight Gain (GWG) monitoring III. Dietary intake monitoring
Control Group
A standard usual prenatal care includes ten clinic visits for routine pregnancy checks (weight gain, iron status, blood pressure, fasting blood glucose etc.)
No interventions assigned to this group
Interventions
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A web/smartphone-based lifestyle program package
There are two platforms for the lifestyle program, namely Health and Nutrition Education (HNE) website and HNE app. The participants are requested to download and register on the HNE website and the HNE app. The HNE app is Android and IOS compatible. Both the HNE website and app are designed to support self-directed learning and independently monitor their GWG and dietary intake during pregnancy. Both the HNE website and app will be passcode protected throughout the study period such that access is restricted to only participants in the intervention group.
The web/smartphone-based lifestyle program package consists of:
I. Health and Nutrition Education (HNE) resources II. Gestational Weight Gain (GWG) monitoring III. Dietary intake monitoring
Eligibility Criteria
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Inclusion Criteria
* At any trimester of pregnancy
* All ethnicities (Malays, Chinese or Indians)
* With or without diseases (diabetes mellitus with/ without insulin, hypertension, dyslipidaemia, overweight/ obese)
Exclusion Criteria
* Severe comorbidities (eg cardiac diseases, kidney diseases severe anemia) that require specific interventions
18 Years
50 Years
FEMALE
Yes
Sponsors
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The World Diabetes Foundation
OTHER
Universiti Putra Malaysia
OTHER
Responsible Party
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Chan Yoke Mun
Professor
Principal Investigators
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Zalilah Mohd Shariff, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Locations
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Health Clinics in Southern of Peninsular Malaysia
Johor Bahru, Johor, Malaysia
Health Clinics in Northern of Peninsular Malaysia
Alor Star, Kedah, Malaysia
Health Clinics in East Coast of Peninsular Malaysia
Kota Bharu, Kelantan, Malaysia
Health Clinics in Southern of Peninsular Malaysia
Malacca, Malacca, Malaysia
Health Clinics in Southern of Peninsular Malaysia
Seremban, Negeri Sembilan, Malaysia
Health Clinics in Central of Peninsular Malaysia
Ipoh, Perak, Malaysia
Health Clinics in Northern of Peninsular Malaysia
George Town, Pulau Pinang, Malaysia
Health Clinics in Central of Peninsular Malaysia
Petaling Jaya, Selangor, Malaysia
Health Clinics in East Coast of Peninsular Malaysia
Kuala Terengganu, Terengganu, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Zalilah Mohd Shariff, PhD
Role: primary
Zalilah Mohd Shariff, PhD
Role: primary
Zalilah Mohd Shariff, PhD
Role: primary
Zalilah Mohd Shariff, PhD
Role: primary
Zalilah Mohd Shariff, PhD
Role: primary
Zalilah Mohd Shariff, PhD
Role: primary
Zalilah Mohd Shariff, PhD
Role: primary
Zalilah Mohd Shariff, PhD
Role: primary
Other Identifiers
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UPM19062022
Identifier Type: -
Identifier Source: org_study_id
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