NCT06258733

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Dec 2025Feb 2027

First Submitted

Initial submission to the registry

February 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

February 6, 2024

Last Update Submit

December 16, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in the effectiveness in raising FL level of a FL workshop given by trained lay leaders vs. experts

    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

    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 Outcomes (1)

  • Change in Mediterranean Diet adherence

    At baseline, last workshop session- up to five weeks since baseline, and three months after intervention

Study Arms (2)

Lay-led FL workshops

EXPERIMENTAL

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.

Behavioral: Lay-led FL workshops

Expert-led FL workshops

EXPERIMENTAL

Trained health experts will disseminate the same manualized program in community groups recruited by research staff to match lay-led groups.

Behavioral: Expert-led workshops

Interventions

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.

Lay-led FL 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.

Expert-led FL workshops

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hebrew or Arabic literate women who are over 25 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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;26(1):124. doi: 10.1186/s12889-025-25597-6.

    PMID: 41339836BACKGROUND
  • 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: 20625115BACKGROUND
  • 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: 29897866BACKGROUND
  • 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: 22050554BACKGROUND
  • 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: 24462490BACKGROUND
  • 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: 23245603BACKGROUND
  • 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: 30642736BACKGROUND
  • 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.

    PMID: 29914503BACKGROUND

MeSH Terms

Conditions

Risk Reduction BehaviorHealth BehaviorFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Study Officials

  • Donna R Zwas, MD, MPH

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR
  • Yael Bar-Zeev, MD, MPH, PhD

    Hebrew University of Jerusalem

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna R Zwas, MD, MPH

CONTACT

Keren L Greenberg, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a quasi-experimental study with two arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Linda Joy Pollin Cardiovascular Wellness Center for Women

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

December 17, 2025

Record last verified: 2025-12