Health BehaviorNCT04138732
Health Behaviors of Medical Personnel in Hospital Maternity Ward
A study testing Improve health behaviors of medical personel in people with Health Behavior and Behavior, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of this study is to characterize the existing health behaviors and obstacles to healthy lifestyle among the medical staff in a maternity ward in order to develop a specifically-tailored intervention to help improve the health behaviors of hospital shift workers.The findings will be used to establish a… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Behavior
- What is being tested?
- Improve health behaviors of medical personel
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jun 2016to 31 Dec 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Doctors, nurses, secretaries, and assistants
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Behaviors of Medical Personnel in Hospital Maternity Ward- Community Based Participatory Pilot
The purpose of this study is to characterize the existing health behaviors and obstacles to healthy lifestyle among the medical staff in a maternity ward in order to develop a specifically-tailored intervention to help improve the health behaviors of hospital shift workers.The findings will be used to establish a community-based participatory health-promoting program in the ward, engaging the staff in its development and implementation.
Read the detailed description
The purpose of this study is to characterize the existing health behaviors and obstacles to healthy lifestyle among the medical staff in a maternity ward in order to develop a specifically-tailored intervention to help improve the health behaviors of hospital shift workers. Shift-work has been associated with unhealthy lifestyles and increased risk of digestive disorders, heart conditions, various kinds of cancer, reproductive dysfunction, and mental conditions. Thus, the findings will be used to establish a community-based participatory health-promoting program in the ward, engaging the staff in its development and implementation. Community Based Participatory (CBP) approach will be used to build an evaluation and intervention. Baseline/needs assessment will be performed by mixed methods approach, combining in depth interviews with key personnel, focus groups and questionnaires that ask about demographics, physical activity and nutrition behaviors, stress, burnout, BMI, and cardiac risk factors.
- Conditions
- Health Behavior, Behavior
- Being tested
- Improve health behaviors of medical personel
- Keywords
- Community, Health, Hospital
- Medical subject headings
- Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improve health behaviors of medical personelBehavioural
This arm will receive the intervention treatment aimed to help improve their health behaviors, as determined by employee-based steering committee. Interventions will target nutrition, physical activity and stress reduction
| Study group | Role | What they receive |
|---|---|---|
| Intervention treatment group | Experimental | This arm will receive the intervention treatment aimed to help improve their health behaviors. Interventions will include nutrition workshops and personal consultation for employees at risk, environmental intervention that includes brief exercise session prior to weekly meetings, placement of sports equipment in the department, and pedometer program, and stress reduction workshops. Healthy options will be demarcated in the hospital cafeteria. Receives: Behavioral: Improve health behaviors of medical personel |
| Control group | Other | This arm will be the control group and not receive the intervention treatment aimed to help improve their health behaviors.Once completing their time as the control group, they will continue into another phase of the trial and receive the intervention treatment. Receives: Behavioral: Improve health behaviors of medical personel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac risk factors
Initially assessed by in depth interviews with key personnel and focus groups and then assessed by self report through questionnaires.
Measured: at the end of the 1 year treatment
Secondary outcomes (4)
BMI
pre and post assesment of BMI via self reporting
Measured: at the end of 1 year of treatment
Burnout
Initially assessed by in depth interviews with key personnel and focus groups and then assessed by self report through questionnaires.
Measured: at the end of the 1 year treatment,
Nutrition behaviors
Initially assessed by in depth interviews with key personnel and focus groups and then assessed by self report through questionnaires assessing mediterrean diet adherence and western diet behavior
Measured: at the end of the 1 year treatment
Physical activity minutes per week
Initially assessed by in depth interviews with key personnel and focus groups and then assessed by self report through questionnaires.
Measured: at the end of the 1 year treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start15 Jun 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
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 Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138732
- Sponsor's protocol ID
- 723HBM- HMO-CTIL
- Status last verified
- Jun 2022
- First submitted
- 27 Aug 2017
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Behaviors of Medical Personnel in Hospital Maternity Ward- Community Based Participatory Pilot
- ClinicalTrials.gov ID
- NCT04138732
- Acronym / sponsor ID
- 723HBM- HMO-CTIL
- Conditions
- Health Behavior, Behavior
- Keywords
- Community, Health, Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 24 Oct 2019 (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 study is to characterize the existing health behaviors and obstacles to healthy lifestyle among the medical staff in a maternity ward in order to develop a specifically-tailored intervention to help improve the health behaviors of hospital shift workers.The findings will be used to establish a community-based participatory health-promoting program in the ward, engaging the staff in its development and implementation.
Detailed description
The purpose of this study is to characterize the existing health behaviors and obstacles to healthy lifestyle among the medical staff in a maternity ward in order to develop a specifically-tailored intervention to help improve the health behaviors of hospital shift workers. Shift-work has been associated with unhealthy lifestyles and increased risk of digestive disorders, heart conditions, various kinds of cancer, reproductive dysfunction, and mental conditions. Thus, the findings will be used to establish a community-based participatory health-promoting program in the ward, engaging the staff in its development and implementation. Community Based Participatory (CBP) approach will be used to build an evaluation and intervention. Baseline/needs assessment will be performed by mixed methods approach, combining in depth interviews with key personnel, focus groups and questionnaires that ask about demographics, physical activity and nutrition behaviors, stress, burnout, BMI, and cardiac risk factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention treatment group | Experimental | Behavioral: Improve health behaviors of medical personelThis arm will receive the intervention treatment aimed to help improve their health behaviors. Interventions will include nutrition workshops and personal consultation for employees at risk, environmental intervention that includes brief exercise session prior to weekly meetings, placement of sports equipment in the department, and pedometer program, and stress reduction workshops. Healthy options will be demarcated in the hospital cafeteria. |
| Control group | Other | Behavioral: Improve health behaviors of medical personelThis arm will be the control group and not receive the intervention treatment aimed to help improve their health behaviors.Once completing their time as the control group, they will continue into another phase of the trial and receive the intervention treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Doctors, nurses, secretaries, and assistants
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 |
|---|---|---|
| Improve health behaviors of medical personelThis arm will receive the intervention treatment aimed to help improve their health behaviors, as determined by employee-based steering committee. Interventions will target nutrition, physical activity and stress reduction | Behavioural | Control group, Intervention treatment group |
Primary outcome
Cardiac risk factors
Time frame: at the end of the 1 year treatment
Initially assessed by in depth interviews with key personnel and focus groups and then assessed by self report through questionnaires.
4 secondary outcomes
BMI
Time frame: at the end of 1 year of treatment
Burnout
Time frame: at the end of the 1 year treatment,
Nutrition behaviors
Time frame: at the end of the 1 year treatment
Physical activity minutes per week
Time frame: at the end of the 1 year treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- 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 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 Improve health behaviors of medical personel in people with Health Behavior and Behavior, 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 1 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: finished, as of the sponsor's last update on 21 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiac risk factors (time frame: at the end of the 1 year treatment). 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 21 Jun 2022.