Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04273412 |
| Other study ID # |
RCDR-GDM |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 13, 2018 |
| Est. completion date |
July 30, 2021 |
Study information
| Verified date |
October 2022 |
| Source |
Rashid Centre for Diabetes and Research |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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%.
