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

Pregnant Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05489536
• Other study ID #: UPM19062022
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Universiti Putra Malaysia
• Contact: Zalilah Mohd Shariff, PhD
• Phone: +603-97692472
• Email: zalilahms[@]upm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Weight Gain
• Pregnant Women
• Weight Gain

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Malaysia	Health Clinics in Northern of Peninsular Malaysia	Alor Setar	Kedah
Malaysia	Health Clinics in Northern of Peninsular Malaysia	George Town	Penang
Malaysia	Health Clinics in Central of Peninsular Malaysia	Ipoh	Perak
Malaysia	Health Clinics in Southern of Peninsular Malaysia	Johor Bahru	Johor
Malaysia	Health Clinics in East Coast of Peninsular Malaysia	Kota Bharu	Kelantan
Malaysia	Health Clinics in East Coast of Peninsular Malaysia	Kuala Terengganu	Terengganu
Malaysia	Health Clinics in Southern of Peninsular Malaysia	Melaka	Malacca
Malaysia	Health Clinics in Central of Peninsular Malaysia	Petaling Jaya	Selangor
Malaysia	Health Clinics in Southern of Peninsular Malaysia	Seremban	Negeri Sembilan

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Putra Malaysia	The World Diabetes Foundation

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	9 months after pregnancy
Secondary	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.	9 months after pregnancy
Secondary	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.	9 months after pregnancy