Clinical Trial

Community-Based Lifestyle Intervention for Diabetes Prevention in Arab Women

Study acronym: CBLI
Recruiting
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Record status
This record was last updated April 25, 2023 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2017-11-30; most recent amendment 2023-04-23.
Status change: Active, Not Recruiting → Recruiting 2019-08-19
Trial Details
NCT Number NCT03358797
Lead Sponsor Hadassah Medical Organization
Conditions Diabetes, Health Behaviors
Enrollment 300 participants
Start Date 2016-12-29
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2023-04-25