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

Primary Purpose

Pregnant Women

Status
Not yet recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
A web/smartphone-based lifestyle program package
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnant Women focused on measuring Health and Nutrition Education (HNE) Resources, Web/smartphone-based Lifestyle Program, Gestational Diabetes Mellitus, Gestational Weight Gain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Sites / Locations

  • Health Clinics in Southern of Peninsular Malaysia
  • Health Clinics in Northern of Peninsular Malaysia
  • Health Clinics in East Coast of Peninsular Malaysia
  • Health Clinics in Southern of Peninsular Malaysia
  • Health Clinics in Southern of Peninsular Malaysia
  • Health Clinics in Northern of Peninsular Malaysia
  • Health Clinics in Central of Peninsular Malaysia
  • Health Clinics in Central of Peninsular Malaysia
  • Health Clinics in East Coast of Peninsular Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A Web/smartphone-based Lifestyle Program Intervention Group

Control Group

Arm Description

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 standard usual prenatal care includes ten clinic visits for routine pregnancy checks (weight gain, iron status, blood pressure, fasting blood glucose etc.)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 6, 2022
Last Updated
August 4, 2022
Sponsor
Universiti Putra Malaysia
Collaborators
The World Diabetes Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05489536
Brief Title
Optimizing Gestational Weight Gain for Prevention of Gestational Diabetes Mellitus in Malaysia
Official Title
A Web/Smartphone-based Lifestyle Program for the Prevention of Gestational Diabetes Mellitus (GDM) in Malaysia: Optimizing Gestational Weight Gain (GWG)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Putra Malaysia
Collaborators
The World Diabetes Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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: 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnant Women
Keywords
Health and Nutrition Education (HNE) Resources, Web/smartphone-based Lifestyle Program, Gestational Diabetes Mellitus, Gestational Weight Gain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A Web/smartphone-based Lifestyle Program Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
A standard usual prenatal care includes ten clinic visits for routine pregnancy checks (weight gain, iron status, blood pressure, fasting blood glucose etc.)
Intervention Type
Behavioral
Intervention Name(s)
A web/smartphone-based lifestyle program package
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of GDM
Description
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.
Time Frame
9 months after pregnancy
Secondary Outcome Measure Information:
Title
Gestational Weight Gain
Description
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.
Time Frame
9 months after pregnancy
Title
Dietary Intake
Description
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.
Time Frame
9 months after pregnancy
Title
Physical Activity
Description
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.
Time Frame
9 months after pregnancy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Medical diagnosis with major psychiatric problems (bipolar depression, schizophrenia, suicidal risk) Severe comorbidities (eg cardiac diseases, kidney diseases severe anemia) that require specific interventions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zalilah Mohd Shariff, PhD
Phone
+603-97692472
Email
zalilahms@upm.edu.my
First Name & Middle Initial & Last Name or Official Title & Degree
Yoke Mun Chan, PhD
Phone
+60397692433
Email
cym@upm.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zalilah Mohd Shariff, PhD
Organizational Affiliation
Universiti Putra Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Clinics in Southern of Peninsular Malaysia
City
Johor Bahru
State/Province
Johor
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zalilah Mohd Shariff, PhD
Facility Name
Health Clinics in Northern of Peninsular Malaysia
City
Alor Setar
State/Province
Kedah
Country
Malaysia
Facility Name
Health Clinics in East Coast of Peninsular Malaysia
City
Kota Bharu
State/Province
Kelantan
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zalilah Mohd Shariff, PhD
Facility Name
Health Clinics in Southern of Peninsular Malaysia
City
Melaka
State/Province
Malacca
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zalilah Mohd Shariff, PhD
Facility Name
Health Clinics in Southern of Peninsular Malaysia
City
Seremban
State/Province
Negeri Sembilan
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zalilah Mohd Shariff, PhD
Facility Name
Health Clinics in Northern of Peninsular Malaysia
City
George Town
State/Province
Penang
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zalilah Mohd Shariff, PhD
Facility Name
Health Clinics in Central of Peninsular Malaysia
City
Ipoh
State/Province
Perak
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zalilah Mohd Shariff, PhD
Facility Name
Health Clinics in Central of Peninsular Malaysia
City
Petaling Jaya
State/Province
Selangor
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zalilah Mohd Shariff, PhD
Facility Name
Health Clinics in East Coast of Peninsular Malaysia
City
Kuala Terengganu
State/Province
Terengganu
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zalilah Mohd Shariff, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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