Clinical trial NCT03201523: Evaluation of a Socio-ecological Cardiovascular Disease Prevention Intervention for Ultra-Orthodox Jewish Hasidic Women
Official title: Evaluation of a Socio-ecological Cardiovascular Disease Prevention Intervention for Ultra-Orthodox Jewish Hasidic Women Using a Participatory Approach
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cardiovascular Diseases
Health Behavior
Keywords: Community-based Intervention
Socio-ecological Model
Participatory Approach
Ultra-Orthodox Jewish women
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 239
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a quasi-experimental, pre-post study.
Primary purpose: PREVENTION

Brief 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).

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Eating behaviors
timeFrame: One year following project completion (4 years later)
measure: Engagement in physical activity
timeFrame: One year following project completion (4 years later)
measure: Reduced risk for obesity (weight, BMI).
timeFrame: One year following project completion (4 years later)
measure: Hours of sleep
timeFrame: One year following project completion (4 years later)
Secondary outcomes:
measure: General Health Self Efficacy
timeFrame: One year following project completion (4 years later)
measure: Spiritual Health Locus of Control
timeFrame: One year following project completion (4 years later)
measure: self perceived health status
timeFrame: One year following project completion (4 years later)
measure: Cardiovascular disease knowledge
timeFrame: One year following project completion (4 years later)
measure: Stages of Change for targeted health behaviors
timeFrame: One year following project completion (4 years later)
measure: health parameters of local population
timeFrame: 3 years prior to intervention, 2 years after intervention.
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah
name: Donna Zwas, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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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.
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.
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.