Optimizing Gestational Weight Gain for Prevention of Gestational Diabetes

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05489536
Study type	Interventional
Source	Universiti Putra Malaysia
Contact	Zalilah Mohd Shariff, PhD
Phone	+603-97692472
Email	zalilahms@upm.edu.my
Status	Not yet recruiting
Phase	N/A
Start date	January 1, 2023
Completion date	December 31, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms