- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03872752
Development and Implementation of Food Literacy Workshops in the Community
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Donna R Zwas, MD, MPH
- Phone Number: 011-972-2-677-9451
- Email: dannaz@hadassah.org.il
Study Contact Backup
- Name: Keren L Greenberg, MPH
- Phone Number: 011-972-2-677-9451
- Email: kereng@hadassah.org.il
Study Locations
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-
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Jerusalem, Israel, 91120
- Recruiting
- Hadassah Medical Organization, Jerusalem, Israel
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Contact:
- Hadas Lemberg, PhD
- Phone Number: 00 972 2 6777572
- Email: lhadas@hadassah.org.il
-
Contact:
- Donna R Zwas, PhD,MPH
- Phone Number: 011-972-2-6779451
- Email: dannaz@hadassah.org.il
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- women who do not meet leadership criteria will be considered for training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lay leader training in FL 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Throughout workshops, taking place throughout one year
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Feasibility of lay-led workshops assessed by number of implemented workshops by lay-leaders
Time Frame: six months after last workshop session
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Percentage of training course graduates who facilitated at least one workshop in the community within six months
|
six months after last workshop session
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Compliance with research assessed by completed surveys
Time Frame: through study completion, an average of 1 year
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Percentage of women who completed both baseline and post survey out of all participants
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through study completion, an average of 1 year
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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)
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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.
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Last session of each workshop (workshops take place throughout one year)
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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)
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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.
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Last session of each workshop, (workshops take place throughout one year)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the level of food literacy
Time Frame: At baseline and three months after intervention
|
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.
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At baseline and three months after intervention
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Change in lay leaders' Self Efficacy: self report questionnaire
Time Frame: At baseline and three months after intervention
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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.
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At baseline and three months after intervention
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Change in Mediterranean Diet adherence
Time Frame: At baseline and three months after intervention
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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.
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At baseline and three months after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Donna R Zwas, MD, MPH, Hadassah Medical Organization
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FL-HMO-CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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