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

Study Overview
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Brief Summary
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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
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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%.

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

Conditions
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Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Behavioral: moderate-intensity lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |