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

NCT04273412 | Completed DMC

• 1 other identifier: RCDR-GDM
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• feto-maternal outcomes

  on delivery

• feto-maternall outcome

  on delivery

• feto-maternal

  on delivery

Study Arms (2)

lifestyle intervention (LI)

EXPERIMENTAL

moderate-intensity lifestyle intervention (Individualised counseling on diet, physical activity, and target weight gain) by license dietitian

Behavioral: moderate-intensity lifestyle intervention

usual standard care group (UC)

NO INTERVENTION

standard antenatal care as per usual clinic protocol

Interventions

moderate-intensity lifestyle intervention BEHAVIORAL

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)

lifestyle intervention (LI)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rashid Centre for Diabetes and Research: lead

Study Sites (1)

Rashid Centre for Diabetes and Research

Ajman, United Arab Emirates

Location

Related Publications (1)

• 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.

  PMID: 36042401 DERIVED

Study Officials

• Amena Sadiya, Ph.D

  Sheikh Khalifa Medical City Ajman

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager Dietetics

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 18, 2020
• Study Start: October 13, 2018
• Primary Completion: July 11, 2021
• Study Completion: July 30, 2021
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)