An interventional study of FL lay leader training and workshop implementation in Lifestyle Risk Reduction, Health Behavior and Food Habits, sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to female participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Prevention
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.
Nutritional factors are responsible for 10% of the global health burden. In Israel, 31% of Jewish women and 52% of Arab women are obese. Diabetes rates are rising in accordance with the rise in obesity. Because of these factors, 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. FL, 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 food literacy skills through the framework of existing community social-structures.
In stage I of the study, community lay leaders from pre-existing community frameworks of Hebrew speaking communities and Arab lay leaders from East Jerusalem will undergo training in a manualized program that enables lay leaders to effectively disseminate FL skills through engaging visual and game-based tools. In stage II the lay leaders will implement the program in their communities.
291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.
This study's enrollment of 260 is above the median of 201 across 250 interventional studies indexed under Risk Reduction Behavior.
Browse Risk Reduction Behavior studies →Hadassah Medical Organization is the lead sponsor of 675 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
- women who do not meet leadership criteria will be considered for training
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.
Behavioral: FL lay leader training and workshop implementation
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.
Feasibility of lay-led workshops assessed by attendance rates
Attendance is monitored to calculate proportion of attendance of participants.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Last session of each workshop (workshops take place throughout one year)
Proportion of participants satisfied with lay-led workshops, assessed by feedback forms
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.
Time frame: Last session of each workshop, (workshops take place throughout one year)
Change in the level of food literacy
Level of food literacy will be assessed by using a food literacy self report scale based on Poelman's Self-Perceived Food Literacy (SPFL) questionnaire, including 23 questions, score ranging between 23-65, the higher the score the higher the food literacy level.
Time frame: At baseline and three months after intervention
Change in lay leaders' Self Efficacy: self report questionnaire
Self Efficacy will be assessed through self report questionnaires (4 questions, 1-5 Likert scale), assessing participants self-efficacy in facilitating the food literacy material to target populations among trainers. The higher the average, the higher the self-efficacy.
Time frame: At baseline and three months after intervention
Change in Mediterranean Diet adherence
Women complete a validated self report survey, the Israel-Mediterranean Diet Adherence Screener (I-MEDAS) reporting on their adherence to the Mediterranean Diet, including consumption of sweets, sweet beverages, fruits and vegetables, whole grains, and legumes. The scale ranges between 1-17, the higher the score the higher the adherence.
Time frame: At baseline and three months after intervention
Ran from May 2019 to primary completion in Jul 2023, 49 months.
Of 167 non-industry interventional studies with no phase under Risk Reduction Behavior, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 42. This study's 49 months is above that.
Counting every sponsor, half of 169 studies reached it within 25 months; a quarter within 13 and three quarters within 46.
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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