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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
Research Initiator: Prof. Vered Kaufman-Shriqui, Department of Nutrition Sciences, Ariel University, Ariel. Email: veredks@ariel.ac.il Clalit HMO Principal Investigator: Dr. Muflah Ataika, Rahat Counseling Clinic, Southern District, Clalit Health Services.
Co-Investigators:
- Dr. Walid El Huzayel, Rahat A Clinic, Southern District, Clalit Health Services.
- Ms. Malak Oubra Abu Alasal, Regional Diabetes Nurse, Southern District, Clalit Health Services.
External Co-Investigators:
- Prof. Mona Boaz, Head of the Department of Nutrition Sciences at Ariel University in Samaria.
- Dr. Maya Maor, Department of Sociology and Anthropology, Ariel University.
- Dr. Samira Alfayoumi Ziadna, Ashkelon College.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Individuals with other chronic diseases that might interfere with the study
- •Pregnant or lactating women
- •Individuals unable to provide informed consent
结局指标
主要结局
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
时间窗: Will be examined three times during one year
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.
次要结局
- Body mass index, (BMI)(Three times during a year)
- Anthropometric measures (waist circumference)(Three times during a year)
- Fasting blood sugar levels (FPG)(Three times during a year)
- Blood lipid profile (LIPID PROFILE)(Three times a year)
- Anthropometric measures (weight)(Three times during a year)
- Health habits and physical activity level(Three times during a year)
- Levels of glycosylated hemoglobin levels (HBA1c)(Three times during a year)
- Anthropometric measures (height)(Three times during a year)
- Blood pressure(Three times during a year)
- Sense of belonging(Three times during a year)
- Reported quality of life(Three times during a year)
研究者
Vered Kaufman Shriqui
Associate Professor
Ariel University