Evaluation of a Socio-ecological Cardiovascular Disease Prevention Intervention for Ultra-Orthodox Jewish Hasidic Women

Cardiovascular Diseases Clinical Trial

Official title:

Evaluation of a Socio-ecological Cardiovascular Disease Prevention Intervention for Ultra-Orthodox Jewish Hasidic Women Using a Participatory Approach

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03201523
• Other study ID #: 465BLZ-HMO-CTIL
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2013
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to design, implement, and evaluate a community level, socio-ecological based CVD prevention intervention using a participatory approach for women in a homogeneous ultra-Orthodox Jewish Hasidic community in Israel. A quasi-experimental, pre-post study design will be utilized, where all community participants will be exposed to intervention components. Pre and post samples will be selected through randomized cluster sampling of pre-existing community groups. It is hypothesized that ultra-Orthodox Jewish Hasidic women exposed to this community intervention will have improved healthy eating behaviors, reduced unhealthy eating behaviors, increased engagement in physical activity and sleep, and reduced risk for obesity (weight, BMI).

Description:

The purpose of this research study is to design, implement, and evaluate a community level, socio-ecological based CVD prevention intervention using a participatory approach for women in a homogeneous ultra-Orthodox Jewish Hasidic community in Israel. A quasi-experimental, pre-post study design will be utilized, where all community participants will be exposed to intervention components. Pre and post samples will be selected through randomized cluster sampling of pre-existing community groups (n=239 ). Intervention components will be designed through qualitative and quantitative data collection (focus groups, interviews, and questionnaires) from the target population and implementation will be conducted in partnership with community organizations. Intervention components will include a health newsletter, health workshops, community evening/health project registration, lay leader training, neighborhood exercise groups, community walking programs with pedometers, healthy cooking contest, and school health promotion activities. It is hypothesized that ultra-Orthodox Jewish Hasidic women exposed to this community intervention will have improved healthy eating behaviors, reduced unhealthy eating behaviors, increased engagement in physical activity and sleep, and reduced risk for obesity (weight, BMI).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 239
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Hebrew, English, or Yiddish speaker
• Ultra-Orthodox Jewish Hasidic woman in the targeted community

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Health Behavior

Intervention

Other:
• Socio-ecologial, community-based intervention
Intervention components will include a health newsletter, health workshops, community evening/health project registration, lay leader training, neighborhood exercise groups, community walking programs with pedometers, healthy cooking contest, and school health promotion activities.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

References & Publications (6)

Barton P, Andronis L, Briggs A, McPherson K, Capewell S. Effectiveness and cost effectiveness of cardiovascular disease prevention in whole populations: modelling study. BMJ. 2011 Jul 28;343:d4044. doi: 10.1136/bmj.d4044. — View Citation

Horowitz CR, Robinson M, Seifer S. Community-based participatory research from the margin to the mainstream: are researchers prepared? Circulation. 2009 May 19;119(19):2633-42. doi: 10.1161/CIRCULATIONAHA.107.729863. — View Citation

Hu FB, Willett WC. Optimal diets for prevention of coronary heart disease. JAMA. 2002 Nov 27;288(20):2569-78. doi: 10.1001/jama.288.20.2569. — View Citation

Macaulay AC, Commanda LE, Freeman WL, Gibson N, McCabe ML, Robbins CM, Twohig PL. Participatory research maximises community and lay involvement. North American Primary Care Research Group. BMJ. 1999 Sep 18;319(7212):774-8. doi: 10.1136/bmj.319.7212.774. No abstract available. — View Citation

McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Q. 1988 Winter;15(4):351-77. doi: 10.1177/109019818801500401. — View Citation

Oguma Y, Shinoda-Tagawa T. Physical activity decreases cardiovascular disease risk in women: review and meta-analysis. Am J Prev Med. 2004 Jun;26(5):407-18. doi: 10.1016/j.amepre.2004.02.007. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eating behaviors	Eating behaviors will be assesses through self report of specific food item consumption via questionnaire	One year following project completion (4 years later)
Primary	Engagement in physical activity	Engagement in physical activity will be assesses through self report of minutes engaged in vigorous and moderate physical activity via questionnaire as well as pedometer step count where relevant	One year following project completion (4 years later)
Primary	Reduced risk for obesity (weight, BMI).	Self report of BMI	One year following project completion (4 years later)
Primary	Hours of sleep	Hours of sleep will be assesses through self report of average hours slept via questionnaire	One year following project completion (4 years later)
Secondary	General Health Self Efficacy	General Health Self Efficacy will be assessed via Ralph Schwarzer's General Health Self Efficacy self report scale, culturally adapted to the population	One year following project completion (4 years later)
Secondary	Spiritual Health Locus of Control	Spiritual Health Locus of Control will be measured through Holt's Spiritual Health Locus of Control scale, culturally adapted to the population	One year following project completion (4 years later)
Secondary	self perceived health status	self perceived health status will be assessed through self report questionnaire	One year following project completion (4 years later)
Secondary	Cardiovascular disease knowledge	Cardiovascular disease knowledge will be assesses through self report questionnaire based on the American Heart Association's knowledge survey items	One year following project completion (4 years later)
Secondary	Stages of Change for targeted health behaviors	Stages of Change for targeted health behaviors will be assesses through self report questionnaire	One year following project completion (4 years later)
Secondary	health parameters of local population	data will be retrieved from local health plans including lipid profile, weight and hemoglobin a1c	3 years prior to intervention, 2 years after intervention.