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Pregnant WomenNCT05489536

Optimizing Gestational Weight Gain for Prevention of Gestational Diabetes Mellitus in Malaysia

A study testing A web/smartphone-based lifestyle program package in people with Pregnant Women, run by Universiti Putra Malaysia at 9 sites in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnant Women
What is being tested?
A web/smartphone-based lifestyle program package
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20,000 participants
Where
9 sitesMalaysia
Study dates
1 Jan 2023to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • Medical diagnosis with major psychiatric problems (bipolar depression, schizophrenia, suicidal risk)
  • Severe comorbidities (eg cardiac diseases, kidney diseases severe anemia) that require specific interventions

Trial locations and contacts

9 sites in 1 country.

Zalilah Mohd Shariff, PhD contact

+603-97692472

zalilahms@upm.edu.my

Yoke Mun Chan, PhD contact

+60397692433

cym@upm.edu.my

9 sites in 1 country

Malaysia9 sites

  • Health Clinics in Northern of Peninsular Malaysia

    Alor Star, Kedah

  • Health Clinics in Northern of Peninsular Malaysia

    George Town, Pulau Pinang

    Zalilah Mohd Shariff, PhD

  • Health Clinics in Central of Peninsular Malaysia

    Ipoh, Perak

    Zalilah Mohd Shariff, PhD

  • Health Clinics in Southern of Peninsular Malaysia

    Johor Bahru, Johor

    Zalilah Mohd Shariff, PhD

  • Health Clinics in East Coast of Peninsular Malaysia

    Kota Bharu, Kelantan

    Zalilah Mohd Shariff, PhD

  • Health Clinics in East Coast of Peninsular Malaysia

    Kuala Terengganu, Terengganu

    Zalilah Mohd Shariff, PhD

  • Health Clinics in Southern of Peninsular Malaysia

    Malacca, Melaka

    Zalilah Mohd Shariff, PhD

  • Health Clinics in Central of Peninsular Malaysia

    Petaling Jaya, Selangor

    Zalilah Mohd Shariff, PhD

  • Health Clinics in Southern of Peninsular Malaysia

    Seremban, Negeri Sembilan

    Zalilah Mohd Shariff, PhD

Other trials in Malaysia

About this study

Official title: A Web/Smartphone-based Lifestyle Program for the Prevention of Gestational Diabetes Mellitus (GDM) in Malaysia: Optimizing Gestational Weight Gain (GWG)

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.

Read the detailed description

General objective: To determine the effectiveness of a web/smartphone-based lifestyle program on optimizing gestational weight gain (GWG) to prevent the incidence of GDM.

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
Pregnant Women
Being tested
A web/smartphone-based lifestyle program package
Keywords
Health and Nutrition Education (HNE) Resources, Web/smartphone-based Lifestyle Program, Gestational Diabetes Mellitus, Gestational Weight Gain
Medical subject headings
Diabetes, Gestational, Gestational Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A web/smartphone-based lifestyle program packageBehavioural

    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:

    1. Health and Nutrition Education (HNE) resources II. Gestational Weight Gain (GWG) monitoring III. Dietary intake monitoring
Study groups in NCT05489536
Study groupRoleWhat they receive
A Web/smartphone-based Lifestyle Program Intervention GroupExperimentalAs 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.
Receives: Behavioral: A web/smartphone-based lifestyle program package
Control GroupNo interventionA standard usual prenatal care includes ten clinic visits for routine pregnancy checks (weight gain, iron status, blood pressure, fasting blood glucose etc.)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 9 months after pregnancy

Secondary outcomes (3)

  1. Gestational Weight Gain

    Women are requested to report their pre-pregnancy weight, the measured height at the maternal and child health (MCH) clinic, as well as the weight at each trimester. If the women could not remember their pre-pregnancy weight, the weight at early pregnancy will be used to estimate pre-pregnancy body mass index (BMI). Total GWG is defined as the last measured weight in the third trimester minus the pre-pregnancy weight or early pregnancy weight, referring to the Institute of Medicine (IOM, 2009). The rate of GWG in the second and third trimesters is defined as the average weekly weight gain in that trimester. Total GWG and rate of GWG will be then categorized as inadequate, adequate or excessive for each category of pre-pregnancy BMI. Percentage of women with insufficient, normal and excessive weight gain will be calculated. The differences in GWG between intervention and control groups will be compared.

    Measured: 9 months after pregnancy

  2. Dietary Intake

    Dietary intake of women at each trimester will be assessed through a semi-quantitative food frequency questionnaire (sFFQ). Women are asked about the frequency and amount (serving size) of intake of each food item. Daily energy, nutrients intake and number of servings (grams) for each food group will be calculated. The differences in dietary intake between intervention and control groups will be compared.

    Measured: 9 months after pregnancy

  3. Physical Activity

    Pregnancy Physical Activity Questionnaire (PPAQ) will be used to determine the physical activity level of pregnant women at each trimester. The PPAQ is a semi-quantitative questionnaire that requests respondents to report the time spent participating in 30 activities, including household/caregiving (12 activities), occupational (5 activities), sports/exercise (7 activities), transportation (3 activities), and sedentary (3 activities). Total activity will be calculated as the sum of all intensity activities and type scores. The differences in physical activity between intervention and control groups will be compared.

    Measured: 9 months after pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start1 Jan 2023 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05489536
Sponsor's protocol ID
UPM19062022
Status last verified
Aug 2022
First submitted
6 Jul 2022
Last updated
8 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing A web/smartphone-based lifestyle program package in people with Pregnant Women, run by Universiti Putra Malaysia at 9 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zalilah Mohd Shariff, PhD (+603-97692472, zalilahms@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of GDM (time frame: 9 months after pregnancy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05489536.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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