Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-01 @ 2:31 PM
Study NCT ID:
NCT04578067
Status:
UNKNOWN
Last Update Posted:
2021-05-27
First Post:
2020-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empowering Immigrant Women for Active and Healthy Lifestyle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster intervenrion trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-26', 'studyFirstSubmitDate': '2020-09-29', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight in kilograms', 'timeFrame': '1 year', 'description': 'Difference in weight change between intervention and control group'}], 'secondaryOutcomes': [{'measure': 'Change in sedentary time (min/day)', 'timeFrame': '1 year', 'description': 'As measured by ActivePal'}, {'measure': 'Change moderately intense physical activity (min/day)', 'timeFrame': '1 year', 'description': 'As measured by ActivePal'}, {'measure': 'Change blood pressure', 'timeFrame': '1 year', 'description': 'as measured by automatic blood pressure measuring device'}, {'measure': 'Change the blood concentration of HbA1c (mmol/mol)', 'timeFrame': '1 year', 'description': 'measured by blood tests'}, {'measure': 'Change the blood concentration of cholesterol (total, LDL and HDL) (mmol/L)', 'timeFrame': '1 year', 'description': 'measured by blood tests'}, {'measure': 'Change the blood concentration of triglycerides (mmol/L)', 'timeFrame': '1 year', 'description': 'measured by blood tests'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Body Weight Changes', 'Physical Activity', 'Blood Glucose', 'Cholesterol, Elevated']}, 'referencesModule': {'references': [{'pmid': '40197263', 'type': 'DERIVED', 'citation': 'Andersen E, Bohler L, Leirbakk MJ, Cabral D, Wedegren MC, Wieland ML, Meyer HE, Madar AA. Effects of a lifestyle programme on accelerometer-measured physical activity level and sedentary time on overweight and obese women of Somali background living in Norway. BMC Public Health. 2025 Apr 7;25(1):1310. doi: 10.1186/s12889-025-22475-z.'}, {'pmid': '38766513', 'type': 'DERIVED', 'citation': 'Bohler L, Meyer HE, Stigum H, Leirbakk MJ, Cabral D, Wedegren MC, Andersen E, Wieland ML, Madar AA. A controlled weight loss intervention study among women of Somali background in Norway. J Migr Health. 2024 May 4;9:100231. doi: 10.1016/j.jmh.2024.100231. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The study will include overweight and obese otherwise healthy women, recruited from two main borough in Oslo with the highest population of Somali origin. The study comprises two phases: A 12-months controlled trial where the participants in the intervention borough will be compared to participants in the control borough. This is followed by a 12-months maintaining phase for the intervention borough where the control group will be given the same intervention as the intervention group received during the first 12-months.', 'detailedDescription': 'Through a research-based intervention program, the overall goal of this project is to promote immigrant health by improving, evolving and adapting a preventive healthcare in the municipality. There is social inequalities and geographical differences in health in Norway. Immigrant women struggle more with overweight and obesity than ethnic Norwegian women, and immigrant women have an increased susceptibility for diabetes and other lifestyle related diseases. In this study, we will measure the effect of a culturally tailored intervention package (physical activity and nutrition) on weight reduction, and cardio-metabolic outcomes, among overweight and obese Somali women. The study will include women (aged 20-67 years) recruited from two boroughs in Oslo with the highest population of Somali origin.\n\nThe intervention program composes a 12-month controlled trial. The core component of the program is to counsel and empower women through individual counseling and group education sessions with emphasis on physical activities and the creation of an enabling environment. The goal is that the participants become more physically active, less sedentary, eat healthy, and maintain these changes long term.\n\nAll main analysis will be done at data collected at the one-year follow up. In addition, the control group in intervention phase will after the completion of the one-year follow up be given the same intervention as the intervention group.\n\nUser involvement is included in the development, planning, implementation and dissemination of the program results. The program will produce evidence, relevant for policy-makers and stakeholders locally and globally, of how to improve health and nutrition strategies towards immigrants and minorities. The program represents a collaboration between Oslo municipality, the University of Oslo and the Norwegian School of Sport Sciences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women living in the two boroughs in Oslo with Somali background (born in Somali regions or women born in Norway by two Somali parents), aged 20-67 years\n* Being overweight or obese (BMI ≥27 kg/m2)\n* Not planning to move away from the recruitment area within the next 2 years\n* Not physically active on a regular basis\n* Willing and able to participate in all aspects of the study\n* Must be capable and willing to sign written informed consent and thumb-print for illiterate participants -\n\nExclusion Criteria:\n\n* Currently pregnant\n* Participating in a formal exercise or weight loss programme\n* Suffering from serious bone or joint problems or difficulty walking\n* Having known chronic diseases such as diabetes, cancer and uncontrolled hypo- or hyperthyroidism\n* Suffering from other illnesses or being on medications that may affect weight loss\n* Suffering from eating disorders\n* Planning to be out of town for more than 6 weeks in the next 12 months'}, 'identificationModule': {'nctId': 'NCT04578067', 'briefTitle': 'Empowering Immigrant Women for Active and Healthy Lifestyle', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Økt Fysisk Aktivitet og Sunnere Livsstil Hos Innvandrer Kvinner (ASLI)', 'orgStudyIdInfo': {'id': '724880 NSD'}, 'secondaryIdInfos': [{'id': '296558/H40', 'type': 'OTHER', 'domain': 'Research Council of Norway'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'culturally tailored intervention package on changes in lifestyle-habits', 'interventionNames': ['Behavioral: Lifestyle intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'on physical activity and healthier eating', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0318', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Ahmed Madar, PHD', 'role': 'CONTACT', 'email': 'a.a.madar@medisin.uio.no', 'phone': '+4722850634'}, {'name': 'Haakon Meyer, PHD', 'role': 'CONTACT', 'email': 'h.e.m@medisin.uio.no'}], 'facility': 'Ahmed Madar', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Ahmed A Madar, PhD', 'role': 'CONTACT', 'email': 'a.a.madar@medisin.uio.no', 'phone': '+4799486552'}, {'name': 'Haakon E Meyer, PhD MD', 'role': 'CONTACT', 'email': 'h.e.meyer@medisin.uio.no'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data protection legislation makes it difficult to share individual data from this study which is limited to approx. 200 participants'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo Municipality', 'class': 'OTHER_GOV'}, {'name': 'Norwegian School of Sport Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Ahmed A. Madar', 'investigatorAffiliation': 'University of Oslo'}}}}