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

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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Diseases; Health Behavior
• Intervention / Treatment: Other: Socio-ecologial, community-based intervention

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 239
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Community members will be exposed to multiple interventions designed through the participatory approach, integrating the socio-ecological model.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Reduced risk for obesity (weight, BMI).	Self report of BMI	One year following project completion (4 years later)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
self perceived health status	self perceived health status will be assessed through self report questionnaire	One year following project completion (4 years later)
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)
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)
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.

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: June 25, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Participatory Approach; Community-based Intervention; Socio-ecological Model; Ultra-Orthodox Jewish women
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 465BLZ-HMO-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No