NCT03872752

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

4.1 years

First QC Date

March 7, 2019

Last Update Submit

December 8, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

    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)

Secondary Outcomes (3)

  • 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

Study Arms (1)

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.

Behavioral: FL lay leader training and workshop implementation

Interventions

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.

Lay leader training in FL intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- women who do not meet leadership criteria will be considered for training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, 91120, Israel

Location

Related Publications (6)

  • 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.

    PMID: 20625115BACKGROUND
  • Desjardins, E.

    BACKGROUND
  • 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.

    PMID: 29897866BACKGROUND
  • 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.

    PMID: 22050554BACKGROUND
  • 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.

    PMID: 24462490BACKGROUND
  • 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.

    PMID: 23245603BACKGROUND

MeSH Terms

Conditions

Risk Reduction BehaviorHealth BehaviorFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Study Officials

  • Donna R Zwas, MD, MPH

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This study includes a pre/post study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Linda Joy Pollin Cardiovascular Wellness Center for Women

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 13, 2019

Study Start

May 15, 2019

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations