Lifestyle Risk ReductionNCT03872752
Development and Implementation of Food Literacy Workshops in the Community
A study testing FL lay leader training and workshop implementation in people with Lifestyle Risk Reduction and Health Behavior, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lifestyle Risk Reduction, Health Behavior, Food Habits
- What is being tested?
- FL lay leader training and workshop implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteIsrael
- Study dates
- 15 May 2019to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who are recognized leaders in the community will be included in training courses
- Participants for the Arab training program must speak and read Arabic
- Participants for the Hebrew-speaking training program must speak and read Hebrew
Who cannot join
- women who do not meet leadership criteria will be considered for training
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Lifestyle Risk Reduction, Health Behavior, Food Habits
- Being tested
- FL lay leader training and workshop implementation
- Medical subject headings
- Risk Reduction Behavior, Health Behavior, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FL lay leader training and workshop implementationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lay leader training in FL intervention | Experimental | 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. Receives: Behavioral: FL lay leader training and workshop implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of lay-led workshops assessed by attendance rates
Attendance is monitored to calculate proportion of attendance of participants.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Last session of each workshop, (workshops take place throughout one year)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At baseline and three months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start15 May 2019
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lifestyle Risk ReductionStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study includes a pre/post study
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donna R Zwas, Hadassah Medical Organization
- Investigators
- Donna R Zwas, MD, MPH, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872752
- Sponsor's protocol ID
- FL-HMO-CTIL
- Status last verified
- Dec 2025
- First submitted
- 7 Mar 2019
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20625115Desjardins, 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.
PubMed 29897866Kalter-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.
PubMed 22050554Vidgen 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.
PubMed 24462490Wang 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.
PubMed 23245603
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of Food Literacy Workshops in the Community
- ClinicalTrials.gov ID
- NCT03872752
- Acronym / sponsor ID
- FL-HMO-CTIL
- Conditions
- Lifestyle Risk Reduction, Health Behavior, Food Habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study includes a pre/post study
| Arm | Type | Receives |
|---|---|---|
| Lay leader training in FL intervention | Experimental | Behavioral: FL lay leader training and workshop implementationCommunity 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women who are recognized leaders in the community will be included in training courses
- Participants for the Arab training program must speak and read Arabic
- Participants for the Hebrew-speaking training program must speak and read Hebrew
Key exclusion criteria (1 listed)
- women who do not meet leadership criteria will be considered for training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FL lay leader training and workshop implementationIntervention 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. | Behavioural | Lay leader training in FL intervention |
Primary outcome
Feasibility of lay-led workshops assessed by attendance rates
Time frame: Throughout workshops, taking place throughout one year
Attendance is monitored to calculate proportion of attendance of participants.
Feasibility of lay-led workshops assessed by number of implemented workshops by lay-leaders
Time frame: six months after last workshop session
Percentage of training course graduates who facilitated at least one workshop in the community within six months
Compliance with research assessed by completed surveys
Time frame: through study completion, an average of 1 year
Percentage of women who completed both baseline and post survey out of all participants
Proportion of participants who accept lay-led workshops, assessed by feedback forms
Time frame: Last session of each workshop (workshops take place throughout one year)
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.
Proportion of participants satisfied with lay-led workshops, assessed by feedback forms
Time frame: Last session of each workshop, (workshops take place throughout one year)
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.
3 secondary outcomes
Change in the level of food literacy
Time frame: At baseline and three months after intervention
Change in lay leaders' Self Efficacy: self report questionnaire
Time frame: At baseline and three months after intervention
Change in Mediterranean Diet adherence
Time frame: At baseline and three months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 20625115Artinian 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.
- BackgroundDesjardins, E.
- Background: PubMed 29897866Estruch 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.
- Background: PubMed 22050554Kalter-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.
- Background: PubMed 24462490Vidgen 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.
- Background: PubMed 23245603Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna R Zwas, MD, MPH principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FL lay leader training and workshop implementation in people with Lifestyle Risk Reduction and Health Behavior, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of lay-led workshops assessed by attendance rates (time frame: Throughout workshops, taking place throughout one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872752, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.