Food Literacy Intervention - is a "Train the Trainer" Approach Feasible and Effective?

Health Behavior Clinical Trial

Official title:

Food Literacy Intervention for Arab and Jewish Women in the Jerusalem Region - is a "Train the Trainer" Approach Feasible and Effective?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258733
• Other study ID #: FL-COST-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: February 2024
• Source: Hadassah Medical Organization
• Contact: Donna R Zwas, MD, MPH
• Phone: 011-972-2-677-9451
• Email: dannaz[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 1, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Women who do not meet inclusion criteria.

Related Conditions & MeSH terms

• Food Habits
• Health Behavior
• Lifestyle Risk Reduction

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Hebrew University of Jerusalem

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 food literacy self report scale based on Poelman's Self-Perceived Food Literacy (SPFL), including 23 questions, score ranging between 23-65, the higher the score the higher the food literacy level.	At baseline and three months after intervention
Primary	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 20 workshops in each arm are implemented. Approximately one year after the beginning of the study.
Secondary	Change in Mediterranean Diet adherence	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 and three months after intervention