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Community-Based Lifestyle Intervention for Diabetes Prevention in Arab Women

Study acronym: CBLI
StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    v7
  2. Primary completion date: Dec 31, 2021 to Dec 31, 2024
    • Study completion date: Dec 31, 2021 to Dec 31, 2025
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Enrollment target: 80 to 300v4 Show 5 more changesShow less
    • Interventions: Community-based intervention (Other) to Attention-control (Behavioral), Community based intervention with resilience training (Behavioral), Pilot (Behavioral), intervention-HPP…
    • Secondary endpoints: 10 to 13
    • Study description expanded, about 456 words
    • Publications: 10 to 13
    • Study arms: 2 to 4
  5. Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Dec 31, 2018 to Dec 31, 2021
    • Study sites: 0 to 1
    • Eligibility criteria revised
    v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03358797
Lead Sponsor Hadassah Medical Organization
Conditions
(from sponsor)		 Diabetes, Health Behaviors
Related terms Diabetes Mellitus, Health Behavior
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov