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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAriel University

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Individuals with other chronic diseases that might interfere with the study

Pregnant or lactating women

Individuals unable to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Healthy lifestyle nutrition, culture and physical activity workshops

    Behavioral

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

  • Usual care

    Other intervention

    Usual care patients receive in their primary health care

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Full InterventionExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

To examine the effect of the intervention on the Mediterranean diet score among patients with obesity, metabolic syndrome, prediabetes, and type 2 diabetes over a period of up to one year from their entry into the study

Examine changes in Mediterranean score using the Mediterranean diet questionnaire (I-MEDAS), the score ranges from 0-17, with a higher value indicating better adherence to the Mediterranean diet pattern.

Time frame
Will be examined three times during one year

Secondary outcomes

1

Fasting blood sugar levels (FPG)

Level of fasting glucose

Time frame
Three times during a year
2

Levels of glycosylated hemoglobin levels (HBA1c)

Level of HBA1C

Time frame
Three times during a year
3

Blood lipid profile (LIPID PROFILE)

Outcomes of a full lipid profile

Time frame
Three times a year
4

Anthropometric measures (weight)

Weight will be measured in kilograms.

Time frame
Three times during a year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ariel University

Lead sponsor

Clalit Health Services

Collaborator