Clinical trials

The goal of the study is to evaluate the effect of nutrition intervention on gastrointestinal symptoms, treatment discontinuation rate, nutritional parameters (e.g., dietary intake and eating habits), anthropometric measures, functional parameters, and QOL during the initiation and up-titration phase of incretin-based Anti Obesity Medications (AOM) treatment in patients with overweight/obesity. The nutrition intervention protocol will be developed based on literature review, focus groups with health care professionals, and patient interviews. A single-center pilot study will be performed at the Tel-Aviv Assuta Medical Center, among 10 patients who are about to initiate long-term weight management treatment with Wegovy© (semaglutide 2.4 mg), followed by a multi-center, parallel design open-label, RCT, which will be conducted at the Tel-Aviv Assuta Medical Center and Rabin Medical Center - Beilinson Hospital, in 120 patients who are about to initiate long-term weight management treatment with Wegovy© or Mounjaro© . The intervention group will receive nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). The control group will receive the usual nutrition care for patients treated with AOM. Primary outcomes (gastrointestinal symptom assessment) and secondary outcomes (incretin-based AOM discontinuation rate, nutritional parameters, anthropometrics, functional parameters and QOL) will be evaluated by interviews, questionnaires and measurements at baseline, at the end of Wegovy© or Mounjaro© titration phase \[20 weeks (T1)\] and weekly during the study period (for GI symptoms assessment).

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.