Clinical trial NCT05489536: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnant Women
Keywords: Health and Nutrition Education (HNE) Resources
Web/smartphone-based Lifestyle Program
Gestational Diabetes Mellitus
Gestational Weight Gain
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: The World Diabetes Foundation
First posted: 2022-08-05
Enrollment: 20000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.

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

Primary outcomes:
measure: Incidence of GDM
timeFrame: 9 months after pregnancy
Secondary outcomes:
measure: Gestational Weight Gain
timeFrame: 9 months after pregnancy
measure: Dietary Intake
timeFrame: 9 months after pregnancy
measure: Physical Activity
timeFrame: 9 months after pregnancy
Other outcomes:
Locations:
city: Johor Bahru
country: Malaysia
facility: Health Clinics in Southern of Peninsular Malaysia
state: Johor
city: Alor Setar
country: Malaysia
facility: Health Clinics in Northern of Peninsular Malaysia
state: Kedah
city: Kota Bharu
country: Malaysia
facility: Health Clinics in East Coast of Peninsular Malaysia
state: Kelantan
city: Melaka
country: Malaysia
facility: Health Clinics in Southern of Peninsular Malaysia
state: Malacca
city: Seremban
country: Malaysia
facility: Health Clinics in Southern of Peninsular Malaysia
state: Negeri Sembilan
city: George Town
country: Malaysia
facility: Health Clinics in Northern of Peninsular Malaysia
state: Penang
city: Ipoh
country: Malaysia
facility: Health Clinics in Central of Peninsular Malaysia
state: Perak
city: Petaling Jaya
country: Malaysia
facility: Health Clinics in Central of Peninsular Malaysia
state: Selangor
city: Kuala Terengganu
country: Malaysia
facility: Health Clinics in East Coast of Peninsular Malaysia
state: Terengganu
Study officials:
affiliation: Universiti Putra Malaysia
name: Zalilah Mohd Shariff, PhD
role: PRINCIPAL_INVESTIGATOR
References: