Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-29 @ 3:11 AM
Study NCT ID:
NCT06258733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2024-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Literacy Intervention - is a "Train the Trainer" Approach Feasible and Effective?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040242', 'term': 'Risk Reduction Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001522', 'term': 'Behavior, Animal'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a quasi-experimental study with two arms'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-02-06', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the effectiveness in raising FL level of a FL workshop given by trained lay leaders vs. experts', 'timeFrame': 'At baseline, last workshop session- up to five weeks since baseline, and three months after intervention', 'description': 'Level of food literacy will be assessed by using a the validated Modified Self-Perceived Food Literacy Scale (M-SPFL) , including 23 questions, mean score ranging between 1-5, the higher the score the higher the food literacy level.'}, {'measure': 'Cost-effectiveness ratio of a FL workshop led by trained lay leaders vs. experts', 'timeFrame': 'After 16 workshops in each arm are implemented. Approximately one year after the beginning of the study.', 'description': 'Cost-effectiveness analysis will compare the two alternatives by calculating the incremental Cost-Effectiveness Ratio (ICER). The Markov chain model will be used to predict short and long-term costs and effectiveness in both arms.'}], 'secondaryOutcomes': [{'measure': 'Change in Mediterranean Diet adherence', 'timeFrame': 'At baseline, last workshop session- up to five weeks since baseline, and three months after intervention', 'description': 'Level of adherence to the Mediterranean Diet will be assessed by the Israeli Mediterranean Diet Adherence Screener (I-MEDAS) self-report validated scale. The scale includes 17 items, score ranging between 1-17, the higher the score the higher the food literacy level.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lifestyle Risk Reduction', 'Health Behavior', 'Food Habits']}, 'referencesModule': {'references': [{'pmid': '41339836', 'type': 'BACKGROUND', 'citation': 'Greenberg KL, Zwas DR, Donchin M, Bar-Zeev Y. Validation and adaptation of the self-perceived food literacy scale (SPFL) among Hebrew and Arabic speaking women in Israel. BMC Public Health. 2025 Dec 4. doi: 10.1186/s12889-025-25597-6. Online ahead of print. No abstract available.'}, {'pmid': '20625115', 'type': 'BACKGROUND', 'citation': 'Artinian NT, Fletcher GF, Mozaffarian D, Kris-Etherton P, Van Horn L, Lichtenstein AH, Kumanyika S, Kraus WE, Fleg JL, Redeker NS, Meininger JC, Banks J, Stuart-Shor EM, Fletcher BJ, Miller TD, Hughes S, Braun LT, Kopin LA, Berra K, Hayman LL, Ewing LJ, Ades PA, Durstine JL, Houston-Miller N, Burke LE; American Heart Association Prevention Committee of the Council on Cardiovascular Nursing. Interventions to promote physical activity and dietary lifestyle changes for cardiovascular risk factor reduction in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 27;122(4):406-41. doi: 10.1161/CIR.0b013e3181e8edf1. Epub 2010 Jul 12. No abstract available.'}, {'pmid': '29897866', 'type': 'BACKGROUND', 'citation': 'Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13.'}, {'pmid': '22050554', 'type': 'BACKGROUND', 'citation': 'Kalter-Leibovici O, Chetrit A, Lubin F, Atamna A, Alpert G, Ziv A, Abu-Saad K, Murad H, Eilat-Adar S, Goldbourt U. Adult-onset diabetes among Arabs and Jews in Israel: a population-based study. Diabet Med. 2012 Jun;29(6):748-54. doi: 10.1111/j.1464-5491.2011.03516.x.'}, {'pmid': '24462490', 'type': 'BACKGROUND', 'citation': 'Vidgen HA, Gallegos D. Defining food literacy and its components. Appetite. 2014 May;76:50-9. doi: 10.1016/j.appet.2014.01.010. Epub 2014 Jan 22.'}, {'pmid': '23245603', 'type': 'BACKGROUND', 'citation': 'Wang H, Dwyer-Lindgren L, Lofgren KT, Rajaratnam JK, Marcus JR, Levin-Rector A, Levitz CE, Lopez AD, Murray CJ. Age-specific and sex-specific mortality in 187 countries, 1970-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2071-94. doi: 10.1016/S0140-6736(12)61719-X.'}, {'pmid': '30642736', 'type': 'BACKGROUND', 'citation': 'Abu-Saad K, Endevelt R, Goldsmith R, Shimony T, Nitsan L, Shahar DR, Keinan-Boker L, Ziv A, Kalter-Leibovici O. Adaptation and predictive utility of a Mediterranean diet screener score. Clin Nutr. 2019 Dec;38(6):2928-2935. doi: 10.1016/j.clnu.2018.12.034. Epub 2019 Jan 5.'}, {'pmid': '29914503', 'type': 'BACKGROUND', 'citation': 'Poelman MP, Dijkstra SC, Sponselee H, Kamphuis CBM, Battjes-Fries MCE, Gillebaart M, Seidell JC. Towards the measurement of food literacy with respect to healthy eating: the development and validation of the self perceived food literacy scale among an adult sample in the Netherlands. Int J Behav Nutr Phys Act. 2018 Jun 18;15(1):54. doi: 10.1186/s12966-018-0687-z.'}]}, 'descriptionModule': {'briefSummary': 'Food literacy (FL) is the capability to make healthy food choices in different contexts, settings and situations. Although eating habits are shaped by different circumstances and skills, most nutrition programs focus on nutrition knowledge alone. Addressing factors such as competencies, self-efficacy and social norms enables sustainable positive change in nutrition behaviour. This study will assess a lay leader-led FL workshop to Arab and Jewish women from disadvantaged communities in the Jerusalem region, utilizing a train-the-trainer approach, and will compare the effectiveness and cost-effectiveness of a lay-led FL intervention to an expert-led intervention.', 'detailedDescription': 'Food literacy (FL) is the capability to make healthy food choices in different contexts, settings and situations. Although eating habits are shaped by different circumstances and skills, most nutrition programs focus on nutrition knowledge alone. Addressing factors such as competencies, self-efficacy and social norms enables sustainable positive change in nutrition behaviour. This study will assess a lay leader-led FL workshop to Arab and Jewish women from disadvantaged communities in the Jerusalem region, utilizing a train-the-trainer approach, and will compare the effectiveness and cost-effectiveness of a manualized FL intervention given by trained lay-leaders vs. the same workshop given by experts.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hebrew or Arabic literate women who are over 25 years old\n\nExclusion Criteria:\n\n* Women who do not meet inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT06258733', 'briefTitle': 'Food Literacy Intervention - is a "Train the Trainer" Approach Feasible and Effective?', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Food Literacy Intervention for Arab and Jewish Women in the Jerusalem Region - is a "Train the Trainer" Approach Feasible and Effective?', 'orgStudyIdInfo': {'id': 'FL-COST-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lay-led FL workshops', 'description': 'Community lay leaders who underwent training in a manualized program will disseminate the workshop to women in their communities through engaging visual and game-based tools.', 'interventionNames': ['Behavioral: Lay-led FL workshops']}, {'type': 'EXPERIMENTAL', 'label': 'Expert-led FL workshops', 'description': 'Trained health experts will disseminate the same manualized program in community groups recruited by research staff to match lay-led groups.', 'interventionNames': ['Behavioral: Expert-led workshops']}], 'interventions': [{'name': 'Lay-led FL workshops', 'type': 'BEHAVIORAL', 'description': 'Groups of women recruited by trained lay-leaders will receive an 8-session lay-led FL workshop. Workshop participants will receive a self-report baseline survey at the first session, and post surveys at the last session and 3 months after the last session. The surveys will be anonymous and will be conducted and collected by the lay workshop facilitator. Lay-leaders will receive an incentive to collect surveys from workshop participants. A member of the research staff will be present at the time of the survey collection to ensure data are collected according to protocol. Monthly phone calls with lay-leaders will take place to ensure implementation in the community, including problem solving and help maintaining motivation. To help ensure implementation in the lay-led arm, lay leaders will be required to complete one workshop in the community before receiving a graduation certificate.', 'armGroupLabels': ['Lay-led FL workshops']}, {'name': 'Expert-led workshops', 'type': 'BEHAVIORAL', 'description': 'Matching groups of women recruited by research staff will receive the same 8-session expert-led FL workshop. Workshop participants will receive a self-report baseline survey at the first session, and post surveys at the last session and 3 months after the last session. The surveys will be anonymous and will be conducted and collected by the expert workshop facilitator.', 'armGroupLabels': ['Expert-led FL workshops']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Donna R Zwas, MD, MPH', 'role': 'CONTACT', 'email': 'dannaz@hadassah.org.il', 'phone': '011-972-2-677-9451'}, {'name': 'Keren L Greenberg, MPH', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Donna R Zwas, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}, {'name': 'Yael Bar-Zeev, MD, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebrew University of Jerusalem'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hebrew University of Jerusalem', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Linda Joy Pollin Cardiovascular Wellness Center for Women', 'investigatorFullName': 'Donna R Zwas', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}