Food Literacy Intervention - is a "Train the Trainer" Approach Feasible and Effective?
NCT ID: NCT06258733
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
480 participants
INTERVENTIONAL
2025-12-31
2027-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lay-led FL workshops
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.
Lay-led FL workshops
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.
Expert-led FL workshops
Trained health experts will disseminate the same manualized program in community groups recruited by research staff to match lay-led groups.
Expert-led workshops
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lay-led FL workshops
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.
Expert-led workshops
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
25 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hebrew University of Jerusalem
OTHER
Hadassah Medical Organization
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Donna R Zwas
Director of Linda Joy Pollin Cardiovascular Wellness Center for Women
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Donna R Zwas, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Yael Bar-Zeev, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
Hebrew University of Jerusalem
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Keren L Greenberg, MPH
Role: CONTACT
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FL-COST-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id