[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560309":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":68,"collaborators":71,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":26,"enrollmentInfo":85,"targetDuration":26,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Ariel University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Full Intervention","EXPERIMENTAL","* Will receive a tailored healthy lifestyle intervention program focusing on nutrition, physical activity, and behavioral changes.\n* Ten sessions will be conducted separately for men and women.\n* Each session will last for approximately 2 hours.\n* The program will include educational workshops, cooking demonstrations, physical activity sessions, and group discussions.",[13],"Behavioral: Healthy lifestyle nutrition, culture and physical activity workshops",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Participants will continue to receive standard care from their healthcare providers without additional intervention.",[19],"Other: Usual care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Healthy lifestyle nutrition, culture and physical activity workshops","The intervention will include monthly sessions in the community setting of physical activity. In addition, monthly nutrition and culture sessions will be held.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Usual care","Usual care patients receive in their primary health care",[15],[32],{"name":33,"affiliation":34,"role":35},"Muflah Ataika, MD","Rahat Counseling Clinic, Southern District, Clalit Health Services.","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Vered Kaufman-Shriqui, PhD","CONTACT","+972587751199","veredks@ariel.ac.il",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Maya Maor, PhD","+972526561087","mayam@ariel.ac.il",[47],{"facility":48,"status":49,"city":50,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Clalit healthcare clinic","RECRUITING","Rahat","Israel","IL",{"type":54,"coordinates":55},"Point",[56,57],34.75699,31.39547,{"lat":57,"lon":56},[60,63,67],{"name":33,"role":39,"phone":61,"phoneExt":26,"email":62},"+972506263930","moflahat@clalit.org.il",{"name":64,"role":39,"phone":65,"phoneExt":26,"email":66},"Malak malakel@clalit.org.il, MA","+972506263956","malakel@clalit.org.il",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":35,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Vered Kaufman Shriqui","Associate Professor",[72],{"name":73,"class":6},"Clalit Health Services","100560309","evaluating-family--community-based-interventions-to-improve-treatment-adherence-in-metabolic-health-among-negev-bedouins-efit-bed-100560309",false,"NCT06575465","Evaluating Family & Community-Based Interventions to Improve Treatment Adherence in Metabolic Health Among Negev Bedouins (EFIT-BED)","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","EFIT-BED","Inclusion Criteria:\n\n* Bedouin men and women aged 18 and above\n* Diagnosed with overweight, obesity, metabolic syndrome, prediabetes, or type 2 diabetes\n* Consent to participate in the study\n\nExclusion Criteria:\n\n* Individuals with other chronic diseases that might interfere with the study\n* Pregnant or lactating women\n* Individuals unable to provide informed consent",true,"ALL","18 Years",{"count":86,"type":87},170,"ESTIMATED","INTERVENTIONAL",[90],"NA","Background:\n\nThe 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.\n\nObjectives:\n\nPrimary: Assess the effect of community intervention on Mediterranean diet adherence.\n\nSecondary: Evaluate changes in fasting glucose, HbA1c, lipid profiles, BMI, physical activity, and quality of life.\n\nMethodology:\n\nStudy Design: Controlled community intervention trial with two groups (intervention and control).\n\nParticipants: 170 Bedouin adults diagnosed with overweight, obesity, metabolic syndrome, prediabetes, or type 2 diabetes.\n\nIntervention: 10 sessions over 12 months focusing on nutrition, physical activity, and behavioral changes, tailored to cultural norms.\n\nControl: 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.\n\nRecruitment and Data Collection:\n\nParticipants 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.\n\nData Analysis:\n\nStatistical analysis will be performed using SAS\u002FSPSS, employing ANOVA, Chi-square tests, and regression models for outcome prediction.\n\nEthical Considerations:\n\nParticipants' privacy will be ensured through coded data storage. The study will comply with Helsinki guidelines, and participants can withdraw at any time.\n\nConclusion:\n\nThis 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.",[93],"Community-Based Participatory Research",[95,96,97,98,99,100],"Type 2 Diabetes Mellitus","Obesity","Community based participatory research","Health promotion","Clinical trial","Prediabetes","2025-01-27",{"date":103,"type":104},"2025-01-28","ACTUAL",{"date":106,"type":104},"2024-09-01",{"date":108,"type":87},"2026-05-31",{"name":5,"class":6},1]