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NCT06575465: EFIT-BED
Evaluating Family & Community-Based Interventions to Improve Treatment Adherence in Metabolic Health Among Negev Bedouins (EFIT-BED)
NA trial testing Healthy lifestyle nutrition, culture and physical activity workshops in Community-Based Participatory Research in 170 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Ariel University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 170 |
| Start date | 1 September 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 May 2026 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Healthy lifestyle nutrition, culture and physical activity workshops
- Usual care
Conditions studied
- Community-Based Participatory Research — all drugs for Community-Based Participatory Research →
Sponsor
Ariel University
Who can join
18 and older, any sex, with Community-Based Participatory Research. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: The Bedouin community in the Negev faces high rates of type 2 diabetes, low treatment adherence, and increased disease complications. Transition to urban living and changing dietary patterns have exacerbated these issues. Current interventions often overlook the potential of culturally tailored approaches leveraging kinship ties and community resources. This study seeks to address these gaps by examining the impact of a family-centered intervention program. Objectives: Primary: Assess the effect of community intervention on Mediterranean diet adherence. Secondary: Evaluate changes in fasting glucose, HbA1c, lipid profiles, BMI, physical activity, and quality of life. Methodology: Study Design: Controlled community intervention trial with two groups (intervention and control). Participants: 170 Bedouin adults diagnosed with overweight, obesity, metabolic syndrome, prediabetes, or type 2 diabetes. Intervention: 10 sessions over 12 months focusing on nutrition, physical activity, and behavioral changes, tailored to cultural norms. Control: Routine care without added intervention. Outcome Measures: Lab tests (HbA1c, lipid profiles), anthropometric measures, Mediterranean diet adherence, physical activity, quality of life, and social belonging. Recruitment and Data Collection: Participants will be recruited via Clalit clinics in Rahat, with the support of local community leaders. Data will be collected through medical records, questionnaires, and physical assessments at baseline, 6, and 12 months. Data Analysis: Statistical analysis will be performed using SAS/SPSS, employing ANOVA, Chi-square tests, and regression models for outcome prediction. Ethical Considerations: Participants' privacy will be ensured through coded data storage. The study will comply with Helsinki guidelines, and participants can withdraw at any time. Conclusion: This study aims to provide culturally tailored interventions to improve health outcomes in the Bedouin community, potentially serving as a model for similar minority groups globally.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT06575465
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06575465 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ariel University
- Last refreshed: 28 January 2025
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing