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

Lifestyle Intervention for the Prevention of Gestational Diabetes Mellitus Among High-risk UAE Population

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Behavioral: moderate-intensity lifestyle intervention

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Arab Emirates
  • Ajman, United Arab Emirates
    • Rashid Centre for Diabetes and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lifestyle intervention (LI); moderate-intensity lifestyle intervention (Individualised counseling on diet, physical activity, and target weight gain) by license dietitian	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)
No Intervention: usual standard care group (UC); standard antenatal care as per usual clinic protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of gestational diabetes mellitus	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	24-28 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feto-maternal outcomes	maternal weight gain	on delivery
feto-maternall outcome	baby birth weight	on delivery
feto-maternal	mode of delivery	on delivery

Collaborators and Investigators

• Sponsor: Rashid Centre for Diabetes and Research
• Investigators: Principal Investigator: Amena Sadiya, Ph.D, Sheikh Khalifa Medical City Ajman

Publications and helpful links

General Publications

• Sadiya A, Jakapure V, Shaar G, Adnan R, Tesfa Y. Lifestyle intervention in early pregnancy can prevent gestational diabetes in high-risk pregnant women in the UAE: a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Aug 30;22(1):668. doi: 10.1186/s12884-022-04972-w.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2018
• Primary Completion (Actual): July 11, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: February 9, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: RCDR-GDM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No