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

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

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

Conditions
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Cardiovascular Diseases, Health Behavior

Intervention / Treatment
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* Other: Socio-ecologial, community-based intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hebrew, English, or Yiddish speaker Ultra-Orthodox Jewish Hasidic woman in the targeted community Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: This is a quasi-experimental, pre-post study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Community members will be exposed to multiple interventions designed through the participatory approach, integrating the socio-ecological model. | Other: Socio-ecologial, community-based intervention<br>* 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.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Socio-ecological Model, Community-based Intervention, Participatory Approach, Ultra-Orthodox Jewish women