Evaluating Family & Community-Based Interventions to Improve Treatment Adherence in Metabolic Health Among Negev Bedouins (EFIT-BED)
NCT Number: NCT06575465
Acronym: EFIT-BED
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Community-Based Participatory Research
Interventions: BEHAVIORAL: Healthy lifestyle nutrition, culture and physical activity workshops|OTHER: Usual care
Sponsor: Ariel University
Collaborators: Clalit Health Services
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 170
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-08-31

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.

Primary Outcome Measures: 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., Will be examined three times during one year
Secondary Outcome Measures: Fasting blood sugar levels (FPG), Level of fasting glucose, Three times during a year|Levels of glycosylated hemoglobin levels (HBA1c), Level of HBA1C, Three times during a year|Blood lipid profile (LIPID PROFILE), Outcomes of a full lipid profile, Three times a year|Anthropometric measures (weight), Weight will be measured in kilograms., Three times during a year|Anthropometric measures (waist circumference), Waist circumference will be measured in centimeters., Three times during a year|Anthropometric measures (height), Height will be measured in meters., Three times during a year|Body mass index, (BMI), Weight and height will be combined to report BMI in kg/m\^2, Three times during a year|Blood pressure, Systolic and diastolic blood pressure in mm/Hg, Three times during a year|Health habits and physical activity level, Assessed using a health and physical activity habits questionnaire. Smoking habits will be self reported., Three times during a year|Reported quality of life, Evaluated using the European Quality of life-5 Dimension (EQ-5D-5L) questionnaire measures health related quality of life. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state, Three times during a year|Sense of belonging, Assessed using a social and community belonging questionnaire. The score ranges from 10-30, higher score indicates higher sense of belonging., Three times during a year