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

NCT ID: NCT03201523

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-01
• Study Completion Date: 2025-12-31

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).

Conditions

Cardiovascular Diseases; Health Behavior

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Community members will be exposed to multiple interventions designed through the participatory approach, integrating the socio-ecological model.

Group Type: EXPERIMENTAL

Socio-ecologial, community-based intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Donna R Zwas

Director of Linda Joy Pollin Cardiovascular Wellness Center for Women

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donna Zwas, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Hadassah

References

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Reference Type: BACKGROUND

PMID: 15165657 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 10488012 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 19451365 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 12444864 (View on PubMed)

Other Identifiers

465BLZ-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id