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RECRUITINGINTERVENTIONAL

Evaluating Family & Community-Based Interventions to Improve Treatment Adherence in Metabolic Health Among Negev Bedouins (EFIT-BED)

Examining the Effectiveness of Family and Community-Based Intervention Programs to Improve Treatment Adherence for Overweight, Obesity, Prediabetes, Metabolic Syndrome, and Type 2 Diabetes in the Bedouin Community in the Negev

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Bedouin men and women aged 18 and above - Diagnosed with overweight, obesity, metabolic syndrome, prediabetes, or type 2 diabetes - Consent to participate in the study Who Should NOT Join This Trial: - Individuals with other chronic diseases that might interfere with the study - Pregnant or lactating women - Individuals unable to provide willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Bedouin men and women aged 18 and above * Diagnosed with overweight, obesity, metabolic syndrome, prediabetes, or type 2 diabetes * Consent to participate in the study Exclusion Criteria: * Individuals with other chronic diseases that might interfere with the study * Pregnant or lactating women * Individuals unable to provide informed consent

Treatments Being Tested

BEHAVIORAL

Healthy lifestyle nutrition, culture and physical activity workshops

The intervention will include monthly sessions in the community setting of physical activity. In addition, monthly nutrition and culture sessions will be held.

OTHER

Usual care

Usual care patients receive in their primary health care

Locations (1)

Clalit healthcare clinic
Rahat, Israel