Lifestyle Intervention for Prevention of Gestational Diabetes Mellitus in the UAE Population

NCT04273412 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2022-10-26

No results posted yet for this study

Summary

Gestational diabetes mellitus (GDM) is a high blood glucose (hyperglycemia) first occurring or first recognized during pregnancy, it is affecting 16.4% of women globally and 36.6 % in this region. It is consistent, strong evidence on the impact of GDM on short and long term health impacts on both mother and her child, thereby presenting significant challenges to acute care and public health. Currently, our understanding of strategies that are effective in preventing GDM is limited. Indeed, prospective studies have indicated a positive result of lifestyle intervention on preventing the risk of GDM in pregnant women but we lack consistency in the findings from randomized controlled trials (RCT). Moreover, most of these trials have been reported from developed countries and none of them were presented from this region. In the present project, we aim to determine whether GDM can be prevented by a 12-week moderate lifestyle intervention compared with usual standard care in high-risk pregnant women. In addition, we will also examine maternal pregnancy and birth outcomes.

Conditions

  • Gestational Diabetes Mellitus in Pregnancy

Interventions

BEHAVIORAL

moderate-intensity lifestyle intervention

standardized 12- week program and would be delivered in 4 sessions (2 individual, 2 telephonic). This lifestyle modification program is a combination of diet therapy (optimum calorie), increased daily physical activity and behavioral modification (self-monitoring, stimulus control, motivational interviewing)

Sponsors & Collaborators

  • Rashid Centre for Diabetes and Research

    lead OTHER

Principal Investigators

  • Amena Sadiya, Ph.D · Sheikh Khalifa Medical City Ajman

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-10-13
Primary Completion
2021-07-11
Completion
2021-07-30

Countries

  • United Arab Emirates

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 NCT04273412 on ClinicalTrials.gov