Sedentary BehaviorNCT04500977
Training Health Promotion Women Community Leaders
A study testing leadership empowerment in people with Sedentary Behavior and Risk Reduction, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Goal of the Program: To develop personal and group ability for participants in the DPP to plan and implement health promotion programs. Objectives: 1. Develop skills in the planning, implementation, and assessment of community-based health promotion programs 2. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Risk Reduction
- What is being tested?
- leadership empowerment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2018to 31 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 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- had to previously take part in the previously implemented diabetes prevention program (DPP)
- had to have interest and ability in developing programs
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem, 91120
Donna Zwas, MD MPH, 972504048274, donnaz1818@gmail.com
Rivka May, bs, 972505406064, rivkatmay@hadassah.org.il
About this study
Official title: Womens Leadership Intervention Program
Goal of the Program:
To develop personal and group ability for participants in the DPP to plan and implement health promotion programs.
Objectives:
- Develop skills in the planning, implementation, and assessment of community-based health promotion programs
- Personal, group and community capacity development in health promotion
Read the detailed description
All participants were graduates of our previously implemented diabetes prevention program (DPP), in which women learned the health dangers involved in a sendentary life style, and unhealthy diet, a lack of planned physical activity, insufficient personal health management, and smoking. The importacne of adopting a healthy lifestyle, and how to achieve this goal was stressed. The 24 graduates most motivated to empower others were chosen to take part in this 12 session leadership program. In the leadership program, women were taught more about the manner in which to bring about a change in one's health by adopting a healthy lifestyle, leadership, and facilitation skills and the development, implementation, and evaluation process required to conduct a community program that will impact society as a whole. Women learned how to map needs and resources, define goals and objectives, implement and evaluate a community based program. Following frontal training, three action grousp were established. Each group was responsible for developing and implementing a program in the community. Programs based on initiatives set during the first stage of the DPP included: working in schools to promote a healthy lifestyle, community work targeting non-working/homemaker women ages 25+, enhancing physical activity in the community, and empowering teens. Together, all of these initiatives: increased awareness of fast food dangers, increased awareness to the dangers of nargillah smoking, and increased awareness as to the importance of physical activity.
- Conditions
- Sedentary Behavior, Risk Reduction
- Being tested
- leadership empowerment
- Medical subject headings
- Sedentary Behavior, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leadership empowermentBehavioural
In the leadership program, women were taught more about the manner in which to bring about a change in one's health by adapting a healthy life style, leadership and facilitation skills and the development, implementation and evaluation process required to conduct a community program that will impact society. Women learned how to map needs and resources, define goals and objectives, develop, implement and evaluate a community based program.
| Study group | Role | What they receive |
|---|---|---|
| Training community health promotion leaderss | Experimental | Community women are trained in leadership and community-based health promotion skills Receives: Behavioral: leadership empowerment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program implementation
Three programs will be implemented by the group within 12 months of initiation of the course.
Measured: 12 months after completion of the course
RE-AIM assessment of intervention quality
The RE-AIM assessment tool assesses Reach, Effectiveness, Adoption, Implementation, and Maintenance of the intervention programs. Each domain is assessed by questions adapted from the RE-AIM framework. Each item is scored as fully implemented, partially implemented or not implemented, with 0 as not, 0.5 as partially and 1.0 as fully, The questions for each item are averaged for a score that ranges from 0-1, with one being full implementation
Measured: 12 months after completion of the course
Secondary outcomes (1)
health promotion leadership self efficacy
13 item questionnaire with scores ranging from 13- 52, with 52 representing higher self efficacy
Measured: upon completion of the course, approximately 14 weeks after initiating the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Sep 2018
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Training of community members in leadership and community-based health promotion skills
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Jerusalem Municipality
- Responsible party
- Principal investigator, Donna R Zwas, Hadassah Medical Organization
- Investigators
- Donna Zwas, MD MPH, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500977
- Sponsor's protocol ID
- LDSP-HMO-CTIL
- Status last verified
- Apr 2023
- First submitted
- 1 Mar 2020
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: deidentified data may be shared upon reasonable investigator request
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
- Womens Leadership Intervention Program
- ClinicalTrials.gov ID
- NCT04500977
- Acronym / sponsor ID
- LDSP-HMO-CTIL
- Conditions
- Sedentary Behavior, Risk Reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Jerusalem Municipality
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Aug 2020 (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.
Goal of the Program:
To develop personal and group ability for participants in the DPP to plan and implement health promotion programs.
Objectives:
- Develop skills in the planning, implementation, and assessment of community-based health promotion programs
- Personal, group and community capacity development in health promotion
Detailed description
All participants were graduates of our previously implemented diabetes prevention program (DPP), in which women learned the health dangers involved in a sendentary life style, and unhealthy diet, a lack of planned physical activity, insufficient personal health management, and smoking. The importacne of adopting a healthy lifestyle, and how to achieve this goal was stressed. The 24 graduates most motivated to empower others were chosen to take part in this 12 session leadership program. In the leadership program, women were taught more about the manner in which to bring about a change in one's health by adopting a healthy lifestyle, leadership, and facilitation skills and the development, implementation, and evaluation process required to conduct a community program that will impact society as a whole. Women learned how to map needs and resources, define goals and objectives, implement and evaluate a community based program. Following frontal training, three action grousp were established. Each group was responsible for developing and implementing a program in the community. Programs based on initiatives set during the first stage of the DPP included: working in schools to promote a healthy lifestyle, community work targeting non-working/homemaker women ages 25+, enhancing physical activity in the community, and empowering teens. Together, all of these initiatives: increased awareness of fast food dangers, increased awareness to the dangers of nargillah smoking, and increased awareness as to the importance of physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Training of community members in leadership and community-based health promotion skills
| Arm | Type | Receives |
|---|---|---|
| Training community health promotion leaderss | Experimental | Behavioral: leadership empowermentCommunity women are trained in leadership and community-based health promotion skills |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- had to previously take part in the previously implemented diabetes prevention program (DPP)
- had to have interest and ability in developing programs
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| leadership empowermentIn the leadership program, women were taught more about the manner in which to bring about a change in one's health by adapting a healthy life style, leadership and facilitation skills and the development, implementation and evaluation process required to conduct a community program that will impact society. Women learned how to map needs and resources, define goals and objectives, develop, implement and evaluate a community based program. | Behavioural | Training community health promotion leaderss |
Primary outcome
Program implementation
Time frame: 12 months after completion of the course
Three programs will be implemented by the group within 12 months of initiation of the course.
RE-AIM assessment of intervention quality
Time frame: 12 months after completion of the course
The RE-AIM assessment tool assesses Reach, Effectiveness, Adoption, Implementation, and Maintenance of the intervention programs. Each domain is assessed by questions adapted from the RE-AIM framework. Each item is scored as fully implemented, partially implemented or not implemented, with 0 as not, 0.5 as partially and 1.0 as fully, The questions for each item are averaged for a score that ranges from 0-1, with one being full implementation
1 secondary outcome
health promotion leadership self efficacy
Time frame: upon completion of the course, approximately 14 weeks after initiating the 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.
- Individual participant dataSharing planned: No. deidentified data may be shared upon reasonable investigator request
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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 Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leadership empowerment in people with Sedentary Behavior and Risk Reduction, run by Hadassah Medical Organization at 1 site in Israel.
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.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Donna Zwas, MD MPH (972504048274, donnaz1818@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program implementation (time frame: 12 months after completion of the course). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.