Lifestyle Intervention for Prevention of Gestational Diabetes Mellitus in the UAE Population
Primary Purpose
Gestational Diabetes Mellitus in Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
moderate-intensity lifestyle intervention
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes Mellitus in Pregnancy
Eligibility Criteria
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.
Sites / Locations
- Rashid Centre for Diabetes and Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
lifestyle intervention (LI)
usual standard care group (UC)
Arm Description
moderate-intensity lifestyle intervention (Individualised counseling on diet, physical activity, and target weight gain) by license dietitian
standard antenatal care as per usual clinic protocol
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
feto-maternal outcomes
maternal weight gain
feto-maternall outcome
baby birth weight
feto-maternal
mode of delivery
Full Information
NCT ID
NCT04273412
First Posted
February 9, 2020
Last Updated
October 24, 2022
Sponsor
Rashid Centre for Diabetes and Research
1. Study Identification
Unique Protocol Identification Number
NCT04273412
Brief Title
Lifestyle Intervention for Prevention of Gestational Diabetes Mellitus in the UAE Population
Official Title
Lifestyle Intervention for the Prevention of Gestational Diabetes Mellitus Among High-risk UAE Population
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 13, 2018 (Actual)
Primary Completion Date
July 11, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rashid Centre for Diabetes and Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lifestyle intervention (LI)
Arm Type
Experimental
Arm Description
moderate-intensity lifestyle intervention (Individualised counseling on diet, physical activity, and target weight gain) by license dietitian
Arm Title
usual standard care group (UC)
Arm Type
No Intervention
Arm Description
standard antenatal care as per usual clinic protocol
Intervention Type
Behavioral
Intervention Name(s)
moderate-intensity lifestyle intervention
Intervention Description
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)
Primary Outcome Measure Information:
Title
incidence of gestational diabetes mellitus
Description
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
Time Frame
24-28 weeks of gestation
Secondary Outcome Measure Information:
Title
feto-maternal outcomes
Description
maternal weight gain
Time Frame
on delivery
Title
feto-maternall outcome
Description
baby birth weight
Time Frame
on delivery
Title
feto-maternal
Description
mode of delivery
Time Frame
on delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amena Sadiya, Ph.D
Organizational Affiliation
Sheikh Khalifa Medical City Ajman
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rashid Centre for Diabetes and Research
City
Ajman
Country
United Arab Emirates
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36042401
Citation
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.
Results Reference
derived
Learn more about this trial
Lifestyle Intervention for Prevention of Gestational Diabetes Mellitus in the UAE Population
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