NCT03358797 Community-Based Lifestyle Intervention for Diabetes Prevention in Arab Women
| NCT ID | NCT03358797 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hadassah Medical Organization |
| Condition | Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2016-12-29 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2016-12-29 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Arab women present increased risk for diabetes, with a 70% greater risk for adult-onset diabetes and a significantly younger age at onset compared with Jewish Israelis. In fact, the rate of diabetes for Arab women in Jerusalem is 4 times higher compared with their Jewish counterparts. Group lifestyle interventions such as the Diabetes Prevention Program (DPP) have documented effectiveness in preventing diabetes; however, many fail to demonstrate outcome maintenance. We predict that integrating leadership skills training into the gold standard DPP would improve the long-term outcome maintenance. Stage 1: A pre-post study design will be utilized, where all community participants will be exposed to intervention components. The sample was selected from pre-existing groups in the local community center, based on their leadership potential. phase 2: The second stage of the trial will not include the leadership component, but instead it will incorporate resiliency training and it aims to evaluate the effect of increased resiliency on the main outcomes including improvement in healthy behaviors such as adherence to Mediterranean diet and as well as a reduction in sedentary lifestyle and increased engagement in physical activity. In addition, resiliency training is likely to improve the maintenance of these behaviors.
Eligibility Criteria
Inclusion Criteria: * Over age 18 * Able to commit to the intervention timetable Exclusion Criteria: * Younger than age 18 * Unable to commit to the intervention timetable * Were not pregnant with expected delivery during the intervention * Were suffering from other serious mental or physical illness
Contact & Investigator
Donna Zwas, MD, MPH
PRINCIPAL INVESTIGATOR
Hadassah University Medical Center
Frequently Asked Questions
Who can join the NCT03358797 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03358797 currently recruiting?
Yes, NCT03358797 is actively recruiting participants. Contact the research team at nigbaria@gmail.com for enrollment information.
Where is the NCT03358797 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT03358797 clinical trial?
NCT03358797 is sponsored by Hadassah Medical Organization. The principal investigator is Donna Zwas, MD, MPH at Hadassah University Medical Center. The trial plans to enroll 300 participants.
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