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

NCT05489536 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20000

Last updated 2022-08-08

No results posted yet for this study

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.

Conditions

  • Pregnant Women

Interventions

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

Sponsors & Collaborators

  • The World Diabetes Foundation

    collaborator OTHER

  • Universiti Putra Malaysia

    lead OTHER

Principal Investigators

  • Zalilah Mohd Shariff, PhD · Universiti Putra Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05489536 on ClinicalTrials.gov