Lifestyle Intervention for Prevention of Gestational Diabetes Mellitus in the UAE Population
Condition: Gestational Diabetes Mellitus in Pregnancy
MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus
Study type: Interventional

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%.
    

Intervention name(s): moderate-intensity lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): 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)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention