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

NCT06575465 | Recruiting

• 1 other identifier: 0133-23-COM
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Type 2 Diabetes Mellitus; Obesity; Community based participatory research; Health promotion; Clinical trial; Prediabetes

Outcome Measures

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.

  Will be examined three times during one year

Secondary Outcomes (11)

• Fasting blood sugar levels (FPG)

  Three times during a year

• Levels of glycosylated hemoglobin levels (HBA1c)

  Three times during a year

• Blood lipid profile (LIPID PROFILE)

  Three times a year

• Anthropometric measures (weight)

  Three times during a year

• Anthropometric measures (waist circumference)

  Three times during a year

Study Arms (2)

Full Intervention

EXPERIMENTAL

* 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.

Behavioral: Healthy lifestyle nutrition, culture and physical activity workshops

Control group

ACTIVE COMPARATOR

Participants will continue to receive standard care from their healthcare providers without additional intervention.

Other: Usual care

Interventions

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.

Full Intervention

Usual care OTHER

Usual care patients receive in their primary health care

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals with other chronic diseases that might interfere with the study
• Pregnant or lactating women
• Individuals unable to provide informed consent

Sponsors & Collaborators

• Ariel University: lead
• Clalit Health Services: collaborator

Study Sites (1)

Clalit healthcare clinic

Rahat, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Prediabetic State

Interventions

Culture Techniques

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

In Vitro Techniques; Investigative Techniques

Study Officials

• Muflah Ataika, MD

  Rahat Counseling Clinic, Southern District, Clalit Health Services.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vered Kaufman-Shriqui, PhD

CONTACT

+972587751199; veredks@ariel.ac.il

Maya Maor, PhD

CONTACT

+972526561087; mayam@ariel.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Study Design: The study is designed as a controlled community intervention trial. Participants will be divided into two groups: an intervention group and a control group. The intervention group will receive a comprehensive community-based intervention program, while the control group will receive routine care. Intervention Group: * Will receive a tailored healthy lifestyle intervention program focusing on nutrition, physical activity, and behavioral changes. * 10 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. Control Group: • They will continue to receive standard care from their healthcare providers without additional intervention. Duration of the Study: • The study will last for one year, with follow-up assessments conducted at baseline, 6 months, and 12 months.

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 28, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)