- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06258733
Food Literacy Intervention - is a "Train the Trainer" Approach Feasible and Effective?
December 16, 2025 updated by: Donna R Zwas, Hadassah Medical Organization
Food Literacy Intervention for Arab and Jewish Women in the Jerusalem Region - is a "Train the Trainer" Approach Feasible and Effective?
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
480
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Donna R Zwas, MD, MPH
- Phone Number: 011-972-2-677-9451
- Email: dannaz@hadassah.org.il
Study Contact Backup
- Name: Keren L Greenberg, MPH
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Hebrew or Arabic literate women who are over 25 years old
Exclusion Criteria:
- Women who do not meet inclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the effectiveness in raising FL level of a FL workshop given by trained lay leaders vs. experts
Time Frame: At baseline, last workshop session- up to five weeks since baseline, and three months after intervention
|
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.
|
At baseline, last workshop session- up to five weeks since baseline, and three months after intervention
|
|
Cost-effectiveness ratio of a FL workshop led by trained lay leaders vs. experts
Time Frame: After 16 workshops in each arm are implemented. Approximately one year after the beginning of the study.
|
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.
|
After 16 workshops in each arm are implemented. Approximately one year after the beginning of the study.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mediterranean Diet adherence
Time Frame: At baseline, last workshop session- up to five weeks since baseline, and three months after intervention
|
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.
|
At baseline, last workshop session- up to five weeks since baseline, and three months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Donna R Zwas, MD, MPH, Hadassah Medical Organization
- Principal Investigator: Yael Bar-Zeev, MD, MPH, PhD, Hebrew University of Jerusalem
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
February 1, 2027
Study Registration Dates
First Submitted
February 6, 2024
First Submitted That Met QC Criteria
February 6, 2024
First Posted (Actual)
February 14, 2024
Study Record Updates
Last Update Posted (Actual)
December 17, 2025
Last Update Submitted That Met QC Criteria
December 16, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FL-COST-HMO-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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