Sedentary LifestylePhase 4NCT01516099
A Structural Approach to Implement the Role of 'Physical Activity Counselors' in Sports and Exercise Promotion
A Phase 4 study testing General Practitioners and Social-cultural organizations in people with Sedentary Lifestyle, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The primary aim of this study is to investigate how a physical activity counselor can offer an added value in the sports and exercise promotion in Flanders. The investigators will explore if the physical activity counselor, in collaboration with the setting of general practitioners and social-cultural associations… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- General Practitioners and Social-cultural organizations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2012to Aug 2013
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18-75 years of age
- Able to walk
Who cannot join
- Severe cardial disease
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Katholieke Universiteit Leuven - Faculty of Kinesiology and Rehabilitation Sciences
Leuven, Vlaams Brabant, 3000
About this study
Official title: Pilot Study: A Structural Approach to Implement the Role of 'Physical Activity Counselors' in Sports and Exercise Promotion in Flanders
The primary aim of this study is to investigate how a physical activity counselor can offer an added value in the sports and exercise promotion in Flanders. The investigators will explore if the physical activity counselor, in collaboration with the setting of general practitioners and social-cultural associations, can refer sedentary people and persons who are active in a non-organized context, into systematic participation in sports and/or exercise. Additionally, the investigators want to determine if the physical activity counselor will succeed in referring the target population to the local supervised and structured sports and exercise activities.
Read the detailed description
Being regularly physically active is a basic component of a healthy lifestyle. However, a large amount of the Flemish population does not reach the prescribed guidelines and cannot enjoy the health benefits related to an active lifestyle. One part of the population is physically active but makes no use of the existing, structured and supervised exercise and sports programs. Therefore the chance on lifetime participation in sports and exercise is quite low in this group. Another group consists of sedentary people that does not participate in any exercise or sports activity at all.
A physical activity counselor can possibly deliver a crucial service for the above mentioned groups. He/she can design an individualized sports- or exercise approach and program. In the short term, the physical activity counselor can guide the participant into his first success experiences regarding exercise and sports. In the long term, the chance of remaining physically active will increase by improving the understanding and the self-confidence of these participants.
However it is questioned how the physical activity counselor can reach these target groups in an efficient way, as the traditional sports and exercise promotion seems to have no impact on these persons. A first alternative may be the setting of the general practitioners. The general practitioner is, as a care provider in primary health care, in a good position to refer sedentary people or those who are active in a non-organized context to a physical activity counselor for 'minimal' coaching. A second alternative can be the setting of the social-cultural associations (e.g. seniors association, women association, neighborhood actions, …). The social context and the local networks in these associations facilitate the proper forms of motivation to exercise with other people and to adapt to a healthy lifestyle.
- Conditions
- Sedentary Lifestyle
- Being tested
- General Practitioners, Social-cultural organizations
- Keywords
- Physical activity counselor, Active and healthy lifestyle, General Practitioner, Social-cultural Organization
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General PractitionersOther
The general practitioner can refer his patients to a physical activity counselor for an individual coaching (intake session with development of program and pretesting, follow up by e-mail or phone (max 4x), personal contact moments (max 3x) and exit session with evaluation and posttesting).
Social-cultural organizationsOther
In the social-cultural organization, members can sign in for group sessions led by the physical activity counselor (intake session with development of program and pretesting, follow up by email or letters (max 4x), personal contact moments (max 4x) and exit session with evaluation and posttesting).
| Study group | Role | What they receive |
|---|---|---|
| General Practitioners | Experimental | The general practitioner can refer his patients to a physical activity counselor for an individual coaching. The investigators aim for a brief coaching period of 10 weeks with the objective that the people continue their active lifestyle afterwards. Receives: Other: General Practitioners |
| Social-cultural organizations | Experimental | In the social-cultural organization, members can sign in for group sessions led by the physical activity counselor. The investigators aim for a brief coaching period of 10 weeks with the objective that the people continue their active lifestyle afterwards. Receives: Other: Social-cultural organizations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health-related anthropometric measures
Length, Weight, Abdominal circumference
Measured: baseline, 10 weeks, 6 months
Change in objective measure of degree of physical activity
Sensewear: little accelerometer that will be carried on the upper arm during several days and consequently registrates the amount of physical activity during this period.
Measured: Baseline, 10 weeks, 6 months
Change in mental well-being
Standardized questionnaire
Measured: Baseline, 10 weeks, 6 months
Change in motivation to be physically active
Standardized questionnaire
Measured: Baseline, 10 weeks, 6 months
Change in participation in local structured sports and exercise
Standardized questionnaire
Measured: Baseline, 10 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Government
- Responsible party
- Principal investigator, Christophe Delecluse, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Christophe Delecluse, PhD, Dr, Principal investigator, Faculty of Kinesiology and Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516099
- Sponsor's protocol ID
- S53801
- Status last verified
- Aug 2013
- First submitted
- 12 Jan 2012
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: A Structural Approach to Implement the Role of 'Physical Activity Counselors' in Sports and Exercise Promotion in Flanders
- ClinicalTrials.gov ID
- NCT01516099
- Acronym / sponsor ID
- S53801
- Conditions
- Sedentary Lifestyle
- Keywords
- Physical activity counselor, Active and healthy lifestyle, General Practitioner, Social-cultural Organization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Belgian Government
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 24 Jan 2012 (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.
The primary aim of this study is to investigate how a physical activity counselor can offer an added value in the sports and exercise promotion in Flanders. The investigators will explore if the physical activity counselor, in collaboration with the setting of general practitioners and social-cultural associations, can refer sedentary people and persons who are active in a non-organized context, into systematic participation in sports and/or exercise. Additionally, the investigators want to determine if the physical activity counselor will succeed in referring the target population to the local supervised and structured sports and exercise activities.
Detailed description
Being regularly physically active is a basic component of a healthy lifestyle. However, a large amount of the Flemish population does not reach the prescribed guidelines and cannot enjoy the health benefits related to an active lifestyle. One part of the population is physically active but makes no use of the existing, structured and supervised exercise and sports programs. Therefore the chance on lifetime participation in sports and exercise is quite low in this group. Another group consists of sedentary people that does not participate in any exercise or sports activity at all.
A physical activity counselor can possibly deliver a crucial service for the above mentioned groups. He/she can design an individualized sports- or exercise approach and program. In the short term, the physical activity counselor can guide the participant into his first success experiences regarding exercise and sports. In the long term, the chance of remaining physically active will increase by improving the understanding and the self-confidence of these participants.
However it is questioned how the physical activity counselor can reach these target groups in an efficient way, as the traditional sports and exercise promotion seems to have no impact on these persons. A first alternative may be the setting of the general practitioners. The general practitioner is, as a care provider in primary health care, in a good position to refer sedentary people or those who are active in a non-organized context to a physical activity counselor for 'minimal' coaching. A second alternative can be the setting of the social-cultural associations (e.g. seniors association, women association, neighborhood actions, …). The social context and the local networks in these associations facilitate the proper forms of motivation to exercise with other people and to adapt to a healthy lifestyle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Practitioners | Experimental | Other: General PractitionersThe general practitioner can refer his patients to a physical activity counselor for an individual coaching. The investigators aim for a brief coaching period of 10 weeks with the objective that the people continue their active lifestyle afterwards. |
| Social-cultural organizations | Experimental | Other: Social-cultural organizationsIn the social-cultural organization, members can sign in for group sessions led by the physical activity counselor. The investigators aim for a brief coaching period of 10 weeks with the objective that the people continue their active lifestyle afterwards. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between 18-75 years of age
- Able to walk
Key exclusion criteria (1 listed)
- Severe cardial disease
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 |
|---|---|---|
| General PractitionersThe general practitioner can refer his patients to a physical activity counselor for an individual coaching (intake session with development of program and pretesting, follow up by e-mail or phone (max 4x), personal contact moments (max 3x) and exit session with evaluation and posttesting). | Other | General Practitioners |
| Social-cultural organizationsIn the social-cultural organization, members can sign in for group sessions led by the physical activity counselor (intake session with development of program and pretesting, follow up by email or letters (max 4x), personal contact moments (max 4x) and exit session with evaluation and posttesting). | Other | Social-cultural organizations |
Primary outcome
Change in health-related anthropometric measures
Time frame: baseline, 10 weeks, 6 months
Length, Weight, Abdominal circumference
Change in objective measure of degree of physical activity
Time frame: Baseline, 10 weeks, 6 months
Sensewear: little accelerometer that will be carried on the upper arm during several days and consequently registrates the amount of physical activity during this period.
Change in mental well-being
Time frame: Baseline, 10 weeks, 6 months
Standardized questionnaire
Change in motivation to be physically active
Time frame: Baseline, 10 weeks, 6 months
Standardized questionnaire
Change in participation in local structured sports and exercise
Time frame: Baseline, 10 weeks, 6 months
Standardized questionnaire
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 13 Aug 2013.
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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.
Christophe Delecluse, PhD, Dr principal investigator
Faculty of Kinesiology and Rehabilitation Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing General Practitioners and Social-cultural organizations in people with Sedentary Lifestyle, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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: finished, as of the sponsor's last update on 13 Aug 2013. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in health-related anthropometric measures (time frame: baseline, 10 weeks, 6 months). The study lists 5 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 13 Aug 2013.