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

NCT03201523 | Unknown

• 1 other identifier: 465BLZ-HMO-CTIL
• Study Type: interventional
• Target: 239
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cardiovascular Diseases; Health Behavior

Keywords

Community-based Intervention; Socio-ecological Model; Participatory Approach; Ultra-Orthodox Jewish women

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• General Health Self Efficacy

  One year following project completion (4 years later)

• Spiritual Health Locus of Control

  One year following project completion (4 years later)

• self perceived health status

  One year following project completion (4 years later)

• Cardiovascular disease knowledge

  One year following project completion (4 years later)

• Stages of Change for targeted health behaviors

  One year following project completion (4 years later)

Study Arms (1)

Intervention

EXPERIMENTAL

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

Other: Socio-ecologial, community-based intervention

Interventions

Socio-ecologial, community-based intervention 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.

Intervention

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Related Publications (6)

• 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.

  PMID: 15165657 BACKGROUND

• 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.

  PMID: 21798967 BACKGROUND

• 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.

  PMID: 3068205 BACKGROUND

• 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.

  PMID: 10488012 BACKGROUND

• 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.

  PMID: 19451365 BACKGROUND

• 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.

  PMID: 12444864 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Donna Zwas, MD, MPH

  Hadassah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Linda Joy Pollin Cardiovascular Wellness Center for Women

Model Details: This is a quasi-experimental, pre-post study.

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: June 28, 2017
• Study Start: November 1, 2013
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share