Cardiovascular DiseasesNCT03201523
Evaluation of a Socio-ecological Cardiovascular Disease Prevention Intervention for Ultra-Orthodox Jewish Hasidic Women
A study testing Socio-ecologial, community-based intervention in people with Cardiovascular Diseases and Health Behavior, run by Hadassah Medical Organization.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Health Behavior
- What is being tested?
- Socio-ecologial, community-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2013to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Hebrew, English, or Yiddish speaker
- Ultra-Orthodox Jewish Hasidic woman in the targeted community
Who cannot join
- None
About this study
Official title: 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).
Read the 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
- Being tested
- Socio-ecologial, community-based intervention
- Keywords
- Community-based Intervention, Socio-ecological Model, Participatory Approach, Ultra-Orthodox Jewish women
- Medical subject headings
- Cardiovascular Diseases, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socio-ecologial, community-based interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Community members will be exposed to multiple interventions designed through the participatory approach, integrating the socio-ecological model. Receives: Other: Socio-ecologial, community-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating behaviors
Eating behaviors will be assesses through self report of specific food item consumption via questionnaire
Measured: 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
Measured: One year following project completion (4 years later)
Reduced risk for obesity (weight, BMI).
Self report of BMI
Measured: 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
Measured: One year following project completion (4 years later)
Secondary outcomes (6)
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
Measured: 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
Measured: One year following project completion (4 years later)
self perceived health status
self perceived health status will be assessed through self report questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: 3 years prior to intervention, 2 years after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Nov 2013
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a quasi-experimental, pre-post study.
- Masking
- None (open label)
- Enrolment
- 239 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donna R Zwas, Hadassah Medical Organization
- Investigators
- Donna Zwas, MD, MPH, Principal investigator, Hadassah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201523
- Sponsor's protocol ID
- 465BLZ-HMO-CTIL
- Status last verified
- Apr 2023
- First submitted
- 6 Mar 2017
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15165657Barton 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.
PubMed 21798967McLeroy 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.
PubMed 3068205Macaulay 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.
PubMed 10488012Horowitz 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.
PubMed 19451365Hu 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.
PubMed 12444864
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Socio-ecological Cardiovascular Disease Prevention Intervention for Ultra-Orthodox Jewish Hasidic Women Using a Participatory Approach
- ClinicalTrials.gov ID
- NCT03201523
- Acronym / sponsor ID
- 465BLZ-HMO-CTIL
- Conditions
- Cardiovascular Diseases, Health Behavior
- Keywords
- Community-based Intervention, Socio-ecological Model, Participatory Approach, Ultra-Orthodox Jewish women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 239 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a quasi-experimental, pre-post study.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Socio-ecologial, community-based interventionCommunity members will be exposed to multiple interventions designed through the participatory approach, integrating the socio-ecological model. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Hebrew, English, or Yiddish speaker
- Ultra-Orthodox Jewish Hasidic woman in the targeted community
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Socio-ecologial, community-based interventionIntervention 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. | Other | Intervention |
Primary outcome
Eating behaviors
Time frame: One year following project completion (4 years later)
Eating behaviors will be assesses through self report of specific food item consumption via questionnaire
Engagement in physical activity
Time frame: One year following project completion (4 years later)
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
Reduced risk for obesity (weight, BMI).
Time frame: One year following project completion (4 years later)
Self report of BMI
Hours of sleep
Time frame: One year following project completion (4 years later)
Hours of sleep will be assesses through self report of average hours slept via questionnaire
6 secondary outcomes
General Health Self Efficacy
Time frame: One year following project completion (4 years later)
Spiritual Health Locus of Control
Time frame: One year following project completion (4 years later)
self perceived health status
Time frame: One year following project completion (4 years later)
Cardiovascular disease knowledge
Time frame: One year following project completion (4 years later)
Stages of Change for targeted health behaviors
Time frame: One year following project completion (4 years later)
health parameters of local population
Time frame: 3 years prior to intervention, 2 years after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 15165657Oguma 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.
- Background: PubMed 21798967Barton 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.
- Background: PubMed 3068205McLeroy 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.
- Background: PubMed 10488012Macaulay 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.
- Background: PubMed 19451365Horowitz 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.
- Background: PubMed 12444864Hu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Zwas, MD, MPH principal investigator
Hadassah
Questions about this trial
What is this clinical trial studying?
A study testing Socio-ecologial, community-based intervention in people with Cardiovascular Diseases and Health Behavior, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating behaviors (time frame: One year following project completion (4 years later)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03201523, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.