HealthyNCT01033110
Fit Over 45 - a Health Promotion Project for Inactive Female Hospital Staff Age 45+ From the University Hospital of Zürich
A study testing Exercise and Nutrition Education in people with Healthy, run by University of Zurich at 1 site in Switzerland.
Trial summary
Background: Despite the well-known benefits of exercise, 64% of the Swiss population do not fulfill the public health recommendation of physical activity. A survey of female staff members over 45 years of age from the University Hospital Zurich at the end of 2003 showed that physical inactivity is also prevalent in… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise and Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 108 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Apr 2012
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- USZ-staff, at least 45 years old, insufficiently active according to the Swiss recommendation of health enhancing physical activity (neither 30 minutes of moderate physical activity at least five days in the week nor 20 minutes of vigorous physical activity at least two times per week) and written informed consent.
Who cannot join
- Acute osteoporotic fracture (<3 month), disability of the musculoskeletal system or cardiovascular diseases which do not allow an endurance training.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Centre on Aging and Mobility
Zurich, Canton of Zurich, 8091
About this study
Background:
Despite the well-known benefits of exercise, 64% of the Swiss population do not fulfill the public health recommendation of physical activity. A survey of female staff members over 45 years of age from the University Hospital Zurich at the end of 2003 showed that physical inactivity is also prevalent in this population.
Read more
Aim:
To assess whether inactive women working at a large hospital centre prefer Nordic Walking (NW) or a Jogging (J) as a health promotion strategy. (2) To test whether the method chosen by the majority improves physical performance, physical activity, body weight and composition, and bone mineral density.
Methods: The investigators will send out a questionnaire to all female staff members at a large hospital centre age 45 and older, ask whether they are inactive, and whether they prefer Nordic Walking or Jogging as a health promotion strategy. Depending on the preference of the majority of the women, the investigators will then ask inactive female staff members age 45+ to participate in a 12-months randomized controlled trial comparing training plus nutrition education to nutrition education alone. The training will have a 3-month building-up phase followed up by an in part unsupervised training of 9 months. All participants will receive a lecture on healthy nutrition once a months for 12 months. The investigators will assess diet with a food frequency questionnaire at baseline and after 12 and 24 months.
The primary endpoint is: physical performance, measured with the 12-minute Coopertest.
The secondary endpoints are: level of physical activity, body mass index, body composition and bone mineral density at the spine and the hip.
Importance: This project will address the questions which physical activities are preferred by inactive women and whether the preferred training improves physical performance, physical activity, body mass index, body composition and bone mineral density. In addition, our study will explore whether those women who changed their diet in addition to being randomized to the training group have an enhanced benefit.
- Conditions
- Healthy
- Being tested
- Exercise and Nutrition Education
- Keywords
- inactive, >45 years, female
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and Nutrition EducationBehavioural
Guided nordic walking training and 12 presentations about diet and health.
What is being measured
The primary outcome is the main question the study is designed to answer.
physical performance
Measured: baseline, 3, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2012
- Study completionApr 2012
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 University of ZurichThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heike Bischoff Ferrari, MD, MPH, Principal investigator, University Hospital Zurich, Centre on Aging and Mobility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033110
- Sponsor's protocol ID
- 1-bischoff
- Status last verified
- Nov 2014
- First submitted
- 25 Nov 2009
- Last updated
- 7 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fit Over 45 - a Health Promotion Project for Inactive Female Hospital Staff Age 45+ From the University Hospital of Zürich
- ClinicalTrials.gov ID
- NCT01033110
- Acronym / sponsor ID
- 1-bischoff
- Conditions
- Healthy
- Keywords
- inactive, >45 years, female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Dec 2009 (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.
Background:
Despite the well-known benefits of exercise, 64% of the Swiss population do not fulfill the public health recommendation of physical activity. A survey of female staff members over 45 years of age from the University Hospital Zurich at the end of 2003 showed that physical inactivity is also prevalent in this population.
Aim:
To assess whether inactive women working at a large hospital centre prefer Nordic Walking (NW) or a Jogging (J) as a health promotion strategy. (2) To test whether the method chosen by the majority improves physical performance, physical activity, body weight and composition, and bone mineral density.
Methods: The investigators will send out a questionnaire to all female staff members at a large hospital centre age 45 and older, ask whether they are inactive, and whether they prefer Nordic Walking or Jogging as a health promotion strategy. Depending on the preference of the majority of the women, the investigators will then ask inactive female staff members age 45+ to participate in a 12-months randomized controlled trial comparing training plus nutrition education to nutrition education alone. The training will have a 3-month building-up phase followed up by an in part unsupervised training of 9 months. All participants will receive a lecture on healthy nutrition once a months for 12 months. The investigators will assess diet with a food frequency questionnaire at baseline and after 12 and 24 months.
The primary endpoint is: physical performance, measured with the 12-minute Coopertest.
The secondary endpoints are: level of physical activity, body mass index, body composition and bone mineral density at the spine and the hip.
Importance: This project will address the questions which physical activities are preferred by inactive women and whether the preferred training improves physical performance, physical activity, body mass index, body composition and bone mineral density. In addition, our study will explore whether those women who changed their diet in addition to being randomized to the training group have an enhanced benefit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- USZ-staff, at least 45 years old, insufficiently active according to the Swiss recommendation of health enhancing physical activity (neither 30 minutes of moderate physical activity at least five days in the week nor 20 minutes of vigorous physical activity at least two times per week) and written informed consent.
Key exclusion criteria (1 listed)
- Acute osteoporotic fracture (<3 month), disability of the musculoskeletal system or cardiovascular diseases which do not allow an endurance training.
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 |
|---|---|---|
| Exercise and Nutrition EducationGuided nordic walking training and 12 presentations about diet and health. | Behavioural | – |
Primary outcome
physical performance
Time frame: baseline, 3, 12 and 24 months
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 7 Nov 2014.
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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.
Heike Bischoff Ferrari, MD, MPH principal investigator
University Hospital Zurich, Centre on Aging and Mobility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Nutrition Education in people with Healthy, run by University of Zurich at 1 site in Switzerland.
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 7 Nov 2014. 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 Switzerland. 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?
physical performance (time frame: baseline, 3, 12 and 24 months). 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 7 Nov 2014.