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

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ClinicalTrials.gov Identifier: NCT04273412
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Dr.Amena Sadiya, 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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus in Pregnancy Behavioral: moderate-intensity lifestyle intervention Not Applicable

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%.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Lifestyle Intervention for the Prevention of Gestational Diabetes Mellitus Among High-risk UAE Population
Actual Study Start Date : October 13, 2018
Estimated Primary Completion Date : June 11, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. incidence of gestational diabetes mellitus [ Time Frame: 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 :
  1. feto-maternal outcomes [ Time Frame: on delivery ]
    maternal weight gain

  2. feto-maternall outcome [ Time Frame: on delivery ]
    baby birth weight

  3. feto-maternal [ Time Frame: on delivery ]
    mode of delivery



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04273412


Contacts
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Contact: Amena Sadiya, Ph.D 0097067147345 sadiya.amena@skmca.ae

Locations
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United Arab Emirates
Rashid Centre for Diabetes and Research Recruiting
Ajman, United Arab Emirates
Principal Investigator: Amena Sadiya, Ph.D         
Sponsors and Collaborators
Rashid Centre for Diabetes and Research
Investigators
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Principal Investigator: Amena Sadiya, Ph.D Sheikh Khalifa Medical City Ajman

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Responsible Party: Dr.Amena Sadiya, Manager Dietetics, Rashid Centre for Diabetes and Research
ClinicalTrials.gov Identifier: NCT04273412    
Other Study ID Numbers: RCDR-GDM
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy in Diabetics
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications