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

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.

Conditions

• Community-Based Participatory Research

Interventions

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

Sponsors & Collaborators

• Clalit Health Services

  collaborator OTHER

• Ariel University

  lead OTHER

Principal Investigators

• Muflah Ataika, MD · Rahat Counseling Clinic, Southern District, Clalit Health Services.

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2025-12-31

Completion

2026-05-31

Countries

• Israel

Study Locations