An interventional study of Lay-led FL workshops and Expert-led workshops in Lifestyle Risk Reduction, Health Behavior and Food Habits, sponsored by Hadassah Medical Organization. Not yet recruiting. Open to female participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Prevention
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.
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.
291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.
This study's planned enrollment of 480 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:
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
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
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.
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.
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.
Time frame: 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.
Time frame: After 16 workshops in each arm are implemented. Approximately one year after the beginning of the study.
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.
Time frame: At baseline, last workshop session- up to five weeks since baseline, and three months after intervention
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Dec 2025; primary completion for Dec 2026, 12 months later.
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 planned 12 months is below that.
Counting every sponsor, half of 169 studies reached it within 25 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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