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

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Behavioral: moderate-intensity lifestyle intervention

• Registration Number: NCT04273412
• Lead Sponsor: Rashid Centre for Diabetes and Research

Brief 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.

Detailed Description

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. If the results show a positive association, we could develop this as a clinical process for improving patient care and cost.

This is a randomized controlled trial where participants will be included if they have more than one risk factors for GDM and randomized to two arms moderate-intensity lifestyle intervention (LI) or usual standard care group (control)(UC) between 6-12 gestational week. For the intervention group, standardized 12- week program and would be delivered in 4 sessions (2 individual, 2 telephonic) by a licensed dietitian. This lifestyle modification program is designed to achieve targeted weight gain and improve glycemic control through a combination of diet therapy, increased daily physical activity, and behavioral modification. The UC participants will receive no session as per the usual clinic protocol. Follow-up until l 24-28 gestational weeks, and the incidence of GDM was used to evaluate the effect of the intervention. At the end of interventions, participants in both arms will receive usual care based on their diagnosis and discretion of their physician. A sample size of 70 participants in each arm was estimated to give the power of 80%.

Study Timeline

• Study Start: 2018-10-13
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-18
• Primary Completion: 2021-07-11
• Study Completion: 2021-07-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

Inclusion Criteria

The study will include pregnant females (≤ 12 weeks of gestation), singleton pregnancy who meet ≥ 2 risk factors for GDM stated below:

• High Risk ethnic group (South Asian, Middle Eastern, Black Carribean)
• Family history of type 2 diabetes, especially in first-degree relatives
• previous macrosomic baby weighing >4.5 kg
• Body mass index greater than 30 kg/m2
• Previous history of GDM or polycystic ovarian syndrome

Exclusion Criteria

• Any form of pregestational diabetes
• Fasting glucose > 126 mg/dL at first prenatal visit.
• Currently using corticosteroids, metformin or other medications interfering with glucose metabolism
• Psychiatric disorders
• Medical conditions preventing any physical exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lifestyle intervention (LI)	moderate-intensity lifestyle intervention	moderate-intensity lifestyle intervention (Individualised counseling on diet, physical activity, and target weight gain) by license dietitian

Primary Outcome Measures

Name	Time	Method
incidence of gestational diabetes mellitus	24-28 weeks of gestation	one or more pathological glucose values in a 75g, 2-h oral glucose tolerance test; fasting plasma glucose ≥ 5.3mmol/L, and 1-h value ≥ 8.6 mmol/L, and 2-h value ≥ 8.6 mmol/L

Secondary Outcome Measures

Name	Time	Method
feto-maternal	on delivery	mode of delivery
feto-maternall outcome	on delivery	baby birth weight
feto-maternal outcomes	on delivery	maternal weight gain

Trial Locations

Locations (1)

Rashid Centre for Diabetes and Research; 🇦🇪 Ajman, United Arab Emirates