Personal Experience and Personal Initiation ProgramPHASENCT01129895
Promoting Health by Self Experience (PHASE) Randomized Controlled Trial
A study testing Health promotion in people with Personal Experience and Personal Initiation Program and Health Prevention Activities, run by Unilever Israel at 1 site in Israel.
Trial summary
Promoting Health by Self Experience (PHASE) randomized controlled trial Study Hypothesis: A personal experience in health promotion will affect the health prevention activities of the health providers and thus will impact their prevention activities toward their patients compared with a control (no-intervention) group. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Personal Experience and Personal Initiation Program, Health Prevention Activities, Impact on Patients
- What is being tested?
- Health promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to May 2011
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Health providers in selected clinics
- Patients age 21-50 in selected clinics
Who cannot join
- Patients age younger than 21 and older than 50
- Health providers from clinics not in the area of the study
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Clalit Health Services
Petah Tikva, Israel
Dorit Erlich, MD, 972507348786, dorite@clalit.org.il
About this study
Promoting Health by Self Experience (PHASE) randomized controlled trial
Study Hypothesis:
A personal experience in health promotion will affect the health prevention activities of the health providers and thus will impact their prevention activities toward their patients compared with a control (no-intervention) group.
Read the detailed description
Objective: To evaluate the effectiveness of a personal experience and personal initiation program on the health prevention activities of the health providers and the following impact on their patients compared with a control (no-intervention) group.
Methods: A randomized controlled trial Randomization: Health providers of all disciplines will be recruited from 10 clinics of Clalit Health Services, Dan district and randomized using cluster (by clinic) randomization, into an intervention and a control group. In each clinic 15 health care providers and 50 patients will be interviewed providing a total of 150 health care providers and 500 patients.
Intervention: The intervention will be delivered by psychologists and social workers trained in group facilitation and experimental learning. The program is based on theories of experimental learning and Bridges model of change. In each intervention clinic 5 workshops on the initiation of health prevention projects in each clinic will be organized by the intervention team and than the clinic will be followed by the intervention team for 6 months. No intervention will be provided to the control clinics.
Outcomes: changes in quality measurements of both intervention and non-intervention clinics. Among health providers changes in attitudes, personal views and life style as well as health prevention activities will be assessed by questionnaires. A random sample of 50 patients age 21-50 from each of the participating clinics will be selected and interviewed using a questionnaire. The questionnaires will include questions regarding the administration of screening tests, treatment of abnormal measurements, life style changes and satisfaction with the performance of the clinic and health care providers. The evaluation for both health care providers and patients will be performed at baseline and after 6 months.
- Conditions
- Personal Experience and Personal Initiation Program, Health Prevention Activities, Impact on Patients
- Being tested
- Health promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promotionBehavioural
In each intervention clinic 5 workshops on the initiation of health prevention projects in each clinic will be organized by the intervention team and than the clinic will be followed by the intervention team for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Health promotion | Experimental | 5 workshops on the initiation of health prevention projects in each clinic will be organized by the intervention team and than the clinic will be followed by the intervention team for 6 months. Receives: Behavioral: Health promotion |
| Promoting Health | No intervention | No intervention follow-up only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Promoting Health randomized controlled trial
Changes in quality measurements Changes in attitudes, personal views and life style as well as health prevention activities
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Personal Experience and Personal Initiation ProgramStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unilever Israel
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Iris Shai, PhD, Principal investigator, Ben-Gurion University of the NegevDanit R Shahar, PhD, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129895
- Sponsor's protocol ID
- unilever-0410-OL
- Acronym
- PHASE
- Status last verified
- Jun 2010
- First submitted
- 22 May 2010
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Shai I, Erlich D, Cohen AD, Urbach M, Yosef N, Levy O, Shahar DR. The effect of personal lifestyle intervention among health care providers on their patients and clinics; the Promoting Health by Self Experience (PHASE) randomized controlled intervention trial. Prev Med. 2012 Oct;55(4):285-291. doi: 10.1016/j.ypmed.2012.08.001. Epub 2012 Aug 12.
PubMed 22906808
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Health by Self Experience (PHASE) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01129895
- Acronym / sponsor ID
- PHASE / unilever-0410-OL
- Conditions
- Personal Experience and Personal Initiation Program, Health Prevention Activities, Impact on Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Unilever IsraelIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 25 May 2010 (estimated)
- 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.
Promoting Health by Self Experience (PHASE) randomized controlled trial
Study Hypothesis:
A personal experience in health promotion will affect the health prevention activities of the health providers and thus will impact their prevention activities toward their patients compared with a control (no-intervention) group.
Detailed description
Objective: To evaluate the effectiveness of a personal experience and personal initiation program on the health prevention activities of the health providers and the following impact on their patients compared with a control (no-intervention) group.
Methods: A randomized controlled trial Randomization: Health providers of all disciplines will be recruited from 10 clinics of Clalit Health Services, Dan district and randomized using cluster (by clinic) randomization, into an intervention and a control group. In each clinic 15 health care providers and 50 patients will be interviewed providing a total of 150 health care providers and 500 patients.
Intervention: The intervention will be delivered by psychologists and social workers trained in group facilitation and experimental learning. The program is based on theories of experimental learning and Bridges model of change. In each intervention clinic 5 workshops on the initiation of health prevention projects in each clinic will be organized by the intervention team and than the clinic will be followed by the intervention team for 6 months. No intervention will be provided to the control clinics.
Outcomes: changes in quality measurements of both intervention and non-intervention clinics. Among health providers changes in attitudes, personal views and life style as well as health prevention activities will be assessed by questionnaires. A random sample of 50 patients age 21-50 from each of the participating clinics will be selected and interviewed using a questionnaire. The questionnaires will include questions regarding the administration of screening tests, treatment of abnormal measurements, life style changes and satisfaction with the performance of the clinic and health care providers. The evaluation for both health care providers and patients will be performed at baseline and after 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health promotion | Experimental | Behavioral: Health promotion5 workshops on the initiation of health prevention projects in each clinic will be organized by the intervention team and than the clinic will be followed by the intervention team for 6 months. |
| Promoting Health | No intervention | –No intervention follow-up only |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Health providers in selected clinics
- Patients age 21-50 in selected clinics
Key exclusion criteria (2 listed)
- Patients age younger than 21 and older than 50
- Health providers from clinics not in the area of the study
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 |
|---|---|---|
| Health promotionIn each intervention clinic 5 workshops on the initiation of health prevention projects in each clinic will be organized by the intervention team and than the clinic will be followed by the intervention team for 6 months. | Behavioural | Health promotion |
Primary outcome
Promoting Health randomized controlled trial
Time frame: 6 months
Changes in quality measurements Changes in attitudes, personal views and life style as well as health prevention activities
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2010.
- Derived from this study: PubMed 22906808Shai I, Erlich D, Cohen AD, Urbach M, Yosef N, Levy O, Shahar DR. The effect of personal lifestyle intervention among health care providers on their patients and clinics; the Promoting Health by Self Experience (PHASE) randomized controlled intervention trial. Prev Med. 2012 Oct;55(4):285-291. doi: 10.1016/j.ypmed.2012.08.001. Epub 2012 Aug 12.
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.
Iris Shai, PhD principal investigator
Ben-Gurion University of the Negev
Danit R Shahar, PhD principal investigator
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health promotion in people with Personal Experience and Personal Initiation Program and Health Prevention Activities, run by Unilever Israel 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 2 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 3 Jun 2010. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Promoting Health randomized controlled trial (time frame: 6 months). 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 NCT01129895, which also lists 1 linked publication.
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 3 Jun 2010.