Optimizing Gestational Weight Gain for Prevention of Gestational Diabetes Mellitus in Malaysia
A Web/Smartphone-based Lifestyle Program for the Prevention of Gestational Diabetes Mellitus (GDM) in Malaysia: Optimizing Gestational Weight Gain (GWG)
1 other identifier
interventional
20,000
1 country
9
Brief Summary
Gestational weight gain (GWG) has been closely related to health outcomes, particularly in gestational diabetes mellitus (GDM). Pregnant women may be particularly motivated to make healthy lifestyle changes. Previous studies showed that lifestyle modification interventions (diet and exercise) may be successful in reducing GWG in high-risk women but their effects on the incidence of GDM and other adverse perinatal outcomes have been limited. The research question for the future full randomized trial is whether an optimizing healthy GWG programme focusing on lifestyle (diet and physical activity) feasible to decrease the risk of GDM in a developing country. Thus, this study aims to evaluate the effectiveness of a web/smartphone-based lifestyle program in optimizing gestational weight gain (GWG) to prevent the incidence of GDM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
9 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
July 6, 2022
CompletedFirst Posted
Study publicly available on registry
August 5, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedAugust 8, 2022
August 1, 2022
12 months
July 6, 2022
August 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of GDM
All pregnant women who attend MCH clinics for prenatal checkups are required to take a standardized 2-hour 75g Oral Glucose Tolerance Test (OGTT) between 28 - 32nd weeks of gestation. Women are requested to report their fasting plasma glucose (FPG) level and 2-hour plasma glucose (2hPG) level. Gestational diabetes mellitus (GDM) is defined as either one or both FPG ≥ 5.1 mmol/L or 2hPG ≥ 7.8 mmol/L. The percentage of women with GDM in both intervention and control groups will be calculated.
9 months after pregnancy
Secondary Outcomes (3)
Gestational Weight Gain
9 months after pregnancy
Dietary Intake
9 months after pregnancy
Physical Activity
9 months after pregnancy
Study Arms (2)
A Web/smartphone-based Lifestyle Program Intervention Group
EXPERIMENTALAs 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.
Control Group
NO INTERVENTIONA standard usual prenatal care includes ten clinic visits for routine pregnancy checks (weight gain, iron status, blood pressure, fasting blood glucose etc.)
Interventions
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
You may qualify if:
- Malaysian women
- At any trimester of pregnancy
- All ethnicities (Malays, Chinese or Indians)
- With or without diseases (diabetes mellitus with/ without insulin, hypertension, dyslipidaemia, overweight/ obese)
You may not qualify if:
- Medical diagnosis with major psychiatric problems (bipolar depression, schizophrenia, suicidal risk)
- Severe comorbidities (eg cardiac diseases, kidney diseases severe anemia) that require specific interventions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universiti Putra Malaysialead
- The World Diabetes Foundationcollaborator
Study Sites (9)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zalilah Mohd Shariff, PhD
Universiti Putra Malaysia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 6, 2022
First Posted
August 5, 2022
Study Start
January 1, 2023
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
August 8, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share