NCT03872752|Completed
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Sponsor study identifier
interventional
260
1 country
1
Study Start
May 15, 2019
Actual (reported)Primary Completion
July 1, 2023
Actual (reported)Study Completion
July 1, 2023
Actual (reported)Nutritional factors are responsible for 10% of the global health burden. In Israel, 31% of Jewish women and 52% of Arab women are obese. It is predicted that this generation will see increased cardiovascular disease (CVD) and decreased life expectancy. Sustained lifestyle changes including small changes in nutrition behavior, can substantially reduce the risk of CVD. Eating habits are affected by different abilities, circumstances, and skill sets, however, most nutrition programs focus on nutrition facts, and less on skills that can help translate knowledge to positive health behaviors and health outcomes. In the last decade a new field has emerged, Food literacy (FL), which acknowledges the importance of addressing skills such as nutrition knowledge, competencies, self-efficacy, literacy and health literacy, so as to enable positive change in nutrition behaviors. Food literacy, in summary, is the capability to make healthy food choices in different contexts, settings and situations. The proposed program seeks to improve nutrition behaviors in disadvantaged communities via a train-the-trainers program, that will provide community leaders with the tools necessary to disseminate FL skills through the framework of existing community social-structures.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 7, 2019
Actual (reported)March 13, 2019
Actual (reported)May 15, 2019
Actual (reported)July 1, 2023
Actual (reported)July 1, 2023
Actual (reported)Feasibility of lay-led workshops assessed by attendance rates
Attendance is monitored to calculate proportion of attendance of participants.
Throughout workshops, taking place throughout one year
Feasibility of lay-led workshops assessed by number of implemented workshops by lay-leaders
Percentage of training course graduates who facilitated at least one workshop in the community within six months
six months after last workshop session
Compliance with research assessed by completed surveys
Percentage of women who completed both baseline and post survey out of all participants
through study completion, an average of 1 year
Proportion of participants who accept lay-led workshops, assessed by feedback forms
Workshop participants complete feedback forms self reporting on acceptability of duration and appropriateness of workshop content on a 1-5 Likert scale. Acceptability will include those who answered 4-5 on the Likert scale.
Last session of each workshop (workshops take place throughout one year)
Proportion of participants satisfied with lay-led workshops, assessed by feedback forms
Change in the level of food literacy
At baseline and three months after intervention
Change in lay leaders' Self Efficacy: self report questionnaire
At baseline and three months after intervention
Change in Mediterranean Diet adherence
At baseline and three months after intervention
Community lay leaders from pre-existing community frameworks will undergo training in a manualized program that enables lay leaders to effectively disseminate food literacy skills through engaging visual and game-based tools in a food literacy workshop. Post training, lay leaders will implement the food literacy workshop in their communities.
Intervention components will include a training course for community lay leaders, enabling them to acquire the skills to lead food literacy workshops. This includes raising their knowledge about nutrition recommendations and food labels, raisin self efficacy, and improving nutrition related organization and preparation skills.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, 91120, Israel
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.
Desjardins, E.
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.
Donna R Zwas, MD, MPH
Hadassah Medical Organization
260 participants (actual enrollment reported by the registry).
First Submitted
March 7, 2019
First Posted
March 13, 2019
Study Start
May 15, 2019
Actual (reported)Repetition Prescription Approaches Delivered Via Videoconferencing
Workshop participants complete feedback forms self reporting on overall satisfaction, satisfaction of workshop methods and satisfaction with facilitator on a 1-5 Likert scale. Satisfaction will include those who answered 4-5 on the Likert scale.
Last session of each workshop, (workshops take place throughout one year)
Contact the study team to confirm eligibility.
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.
Primary Completion
July 1, 2023
Actual (reported)Study Completion
July 1, 2023
Actual (reported)Last Updated
December 16, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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