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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Israel
Clalit healthcare clinic
RECRUITING
Rahat
Contact Information
Primary
Vered Kaufman-Shriqui, PhD
veredks@ariel.ac.il
+972587751199
Backup
Maya Maor, PhD
mayam@ariel.ac.il
+972526561087
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 170
Treatments
Experimental: Full Intervention
* Will receive a tailored healthy lifestyle intervention program focusing on nutrition, physical activity, and behavioral changes.~* Ten sessions will be conducted separately for men and women.~* Each session will last for approximately 2 hours.~* The program will include educational workshops, cooking demonstrations, physical activity sessions, and group discussions.
Active_comparator: Control group
Participants will continue to receive standard care from their healthcare providers without additional intervention.
Sponsors
Leads: Ariel University
Collaborators: Clalit Health Services

This content was sourced from clinicaltrials.gov