Clinical trial NCT04273412: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Rashid Centre for Diabetes and Research
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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%.

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.

Primary outcomes:
measure: incidence of gestational diabetes mellitus
timeFrame: 24-28 weeks of gestation
Secondary outcomes:
measure: feto-maternal outcomes
timeFrame: on delivery
measure: feto-maternall outcome
timeFrame: on delivery
measure: feto-maternal
timeFrame: on delivery
Other outcomes:
Locations:
city: Ajman
country: United Arab Emirates
facility: Rashid Centre for Diabetes and Research
Study officials:
affiliation: Sheikh Khalifa Medical City Ajman
name: Amena Sadiya, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.