HealthyNCT01172834
The Possible Influence of Health Promotion Coaching on Health Related and Organizational Outcomes Among Nurses
A study testing Health Coaching in people with Healthy, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Strong evidence shows that physical activity (PA) has favorable psychological and health related outcomes. However, most employees do not perform enough PA to achieve health and well being benefits. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Dec 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nurses working in a full time capacity at Tel-Aviv Sourasky Medical Center.
Who cannot join
- None nurses or nurses working part-time at Tel-Aviv Sourasky Medical Center.
- Nurses not working at Tel-Aviv Sourasky Medical Center.
Trial locations and contacts
1 site in 1 country.
About this study
Strong evidence shows that physical activity (PA) has favorable psychological and health related outcomes. However, most employees do not perform enough PA to achieve health and well being benefits. Worksite interventions aimed at improving PA often yield modest effect sizes, and their theoretical ground is not profound. The Health Action Process Approach (HAPA), is a novel comprehensive theoretical model for health behavior change, that hasn't been studied as a whole in a worksite intervention study.
The objectives of the proposed study are:
Read more
- To develop a coaching-based group intervention that will be both grounded in theory (HAPA) as well as applicable.
- To evaluate the feasibility of conducting this intervention among employed hospital nurses, using a randomized controlled design, interviews and other evaluation procedures.
The proposed study will offer the most comprehensive empirical test to date of the full HAPA model.
- Conditions
- Healthy
- Being tested
- Health Coaching
- Keywords
- Nurses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
A manual-driven group Health Coaching intervention. Once a week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Behavioral: Health Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Syndrome Ratings
(Blood pressure, Sugar levels, HDL, Triglycerides, Weight)
Measured: Time 0
Metabolic Syndrome Ratings
(Blood pressure, Sugar levels, HDL, Triglycerides, Weight)
Measured: Time 1 - 3 months Follow up
Metabolic Syndrome Ratings
(Blood pressure, Sugar levels, HDL, Triglycerides, Weight)
Measured: Time 2 - 6 Months Follow up
Metabolic Syndrome Ratings
(Blood pressure, Sugar levels, HDL, Triglycerides, Weight)
Measured: Time 3 - 9 Months Follow up
Secondary outcomes (13)
Organizational Behavior Ratings
Absenteeism,Perceived Organizational Support, Organizational Cynicism, Vigor, exhaustion, Peer Support, Social networks
Measured: Time 0
Psychological Ratings
Subjective Well-Being, Psychological Well-Being, Positive and Negative Affect, Self Efficacy, HAPA Stage
Measured: Time 0
Demographic ratings
Age, Gender, Seniority, Marital Status, Number of Kids
Measured: Time 0
Coaching Process Ratings
Goal Attainment
Measured: Time 0
Organizational Behavior Ratings
Absenteeism,Perceived Organizational Support, Organizational Cynicism, Vigor, exhaustion, Peer Support, Social networks
Measured: Time 1 - 3 months follow up
Organizational Behavior Ratings
Absenteeism,Perceived Organizational Support, Organizational Cynicism, Vigor, exhaustion, Peer Support, Social networks
Measured: Time 2 - 6 Months Follow up
Psychological Ratings
Subjective Well-Being, Psychological Well-Being, Positive and Negative Affect, Self Efficacy, HAPA Stage
Measured: Time 1 - 3 months follow up
Psychological Ratings
Subjective Well-Being, Psychological Well-Being, Positive and Negative Affect, Self Efficacy, HAPA Stage
Measured: Time 2 - 6 Months Follow up
Coaching Process Ratings
Goal Attainment
Measured: Time 1 - 3 months follow up
Coaching Process Ratings
Goal Attainment
Measured: Time 2 - 6 Months Follow up
Organizational Behavior Ratings
Absenteeism,Perceived Organizational Support, Organizational Cynicism, Vigor, exhaustion, Peer Support, Social networks
Measured: Time 3 - 9 Months Follow up
Psychological Ratings
Subjective Well-Being, Psychological Well-Being, Positive and Negative Affect, Self Efficacy, HAPA Stage
Measured: Time 3 - 9 Months Follow up
Coaching Process Ratings
Goal Attainment
Measured: Time 3 - 9 Months Follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
- Investigators
- Izthak Shapira, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172834
- Sponsor's protocol ID
- TASMC-09-IS-0258-09-TLV-CTIL
- Status last verified
- Jul 2010
- First submitted
- 18 Jul 2010
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Influence of Health Promotion Coaching on Health Related and Organizational Outcomes Among Nurses
- ClinicalTrials.gov ID
- NCT01172834
- Acronym / sponsor ID
- TASMC-09-IS-0258-09-TLV-CTIL
- Conditions
- Healthy
- Keywords
- Nurses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 30 Jul 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.
Strong evidence shows that physical activity (PA) has favorable psychological and health related outcomes. However, most employees do not perform enough PA to achieve health and well being benefits. Worksite interventions aimed at improving PA often yield modest effect sizes, and their theoretical ground is not profound. The Health Action Process Approach (HAPA), is a novel comprehensive theoretical model for health behavior change, that hasn't been studied as a whole in a worksite intervention study.
The objectives of the proposed study are:
- To develop a coaching-based group intervention that will be both grounded in theory (HAPA) as well as applicable.
- To evaluate the feasibility of conducting this intervention among employed hospital nurses, using a randomized controlled design, interviews and other evaluation procedures.
The proposed study will offer the most comprehensive empirical test to date of the full HAPA model.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Health Coaching |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nurses working in a full time capacity at Tel-Aviv Sourasky Medical Center.
Key exclusion criteria (2 listed)
- None nurses or nurses working part-time at Tel-Aviv Sourasky Medical Center.
- Nurses not working at Tel-Aviv Sourasky Medical Center.
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 CoachingA manual-driven group Health Coaching intervention. Once a week for 3 months. | Behavioural | Lifestyle counseling |
Primary outcome
Metabolic Syndrome Ratings
Time frame: Time 0
(Blood pressure, Sugar levels, HDL, Triglycerides, Weight)
Metabolic Syndrome Ratings
Time frame: Time 1 - 3 months Follow up
(Blood pressure, Sugar levels, HDL, Triglycerides, Weight)
Metabolic Syndrome Ratings
Time frame: Time 2 - 6 Months Follow up
(Blood pressure, Sugar levels, HDL, Triglycerides, Weight)
Metabolic Syndrome Ratings
Time frame: Time 3 - 9 Months Follow up
(Blood pressure, Sugar levels, HDL, Triglycerides, Weight)
13 secondary outcomes
Organizational Behavior Ratings
Time frame: Time 0
Psychological Ratings
Time frame: Time 0
Demographic ratings
Time frame: Time 0
Coaching Process Ratings
Time frame: Time 0
Organizational Behavior Ratings
Time frame: Time 1 - 3 months follow up
Organizational Behavior Ratings
Time frame: Time 2 - 6 Months Follow up
Psychological Ratings
Time frame: Time 1 - 3 months follow up
Psychological Ratings
Time frame: Time 2 - 6 Months Follow up
Coaching Process Ratings
Time frame: Time 1 - 3 months follow up
Coaching Process Ratings
Time frame: Time 2 - 6 Months Follow up
Organizational Behavior Ratings
Time frame: Time 3 - 9 Months Follow up
Psychological Ratings
Time frame: Time 3 - 9 Months Follow up
Coaching Process Ratings
Time frame: Time 3 - 9 Months Follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2010.
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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.
Izthak Shapira, MD principal investigator
Tel-Aviv Sourasky Medical Center
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 Coaching in people with Healthy, run by Tel-Aviv Sourasky Medical Center 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 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 30 Jul 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?
Contact Izthak Shapira, MD (972-52-4262626, shapiraiz@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Syndrome Ratings (time frame: Time 0). 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?
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 30 Jul 2010.