Motivation for Physical ActivityDALICONCT01187576
A Multi-professional Team Intervention on Physical Activity Referrals in Primary Care Patients With Cardiovascular Risk Factors-the Dalby Lifestyle Intervention Cohort (DALICO) Study
A study testing Multi-professional team intervention with PAR, lifestyle brochure and Ordinary recommendations on health behaviours, lifestyle brochure in people with Motivation for Physical Activity, run by Region Skane at 1 site in Sweden.
Trial summary
Background The present study protocol describes the trial design of a primary care intervention cohort study, which examines whether an extended, multi-professional physical activity referral (PAR) intervention is more effective in enhancing and maintaining self-reported physical activity than ordinary physical… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Motivation for Physical Activity
- What is being tested?
- Multi-professional team intervention with PAR, lifestyle brochure and Ordinary recommendations on health behaviours, lifestyle brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2010to Nov 2010
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-professional Team Intervention on Physical Activity Referrals in Primary Care Patients With Cardiovascular Risk factors-the Dalby Lifestyle Intervention Cohort Study (DALICO) Study
Background The present study protocol describes the trial design of a primary care intervention cohort study, which examines whether an extended, multi-professional physical activity referral (PAR) intervention is more effective in enhancing and maintaining self-reported physical activity than ordinary physical activity recommendations. The study targets patients with newly diagnosed hypertension and/or type 2 diabetes.
Secondary outcomes include: need of pharmacological therapy; blood pressure/plasma glucose; physical fitness and anthropometric variables; mental health; health related quality of life; and cost-effectiveness. Methods/Design The study is designed as a long-term intervention. Three primary care centres are involved in the study, each constituting one of three treatment groups: 1) Intervention group (IG): multi-professional team intervention with PAR, lifestyle brochure; 2) Control group A (CA): ordinary recommendations on health behaviours, lifestyle brochure; and 3) Control group B: treatment as usual (retrospective data collection).
Read more
The intervention is based on self-determination theory and follows the principles of motivational interviewing. Physical activity is measured with the International Physical Activity Questionnaire (IPAQ) and expressed as metabolic equivalent of task (MET)-minutes per week. Physical fitness is estimated with the 6-minute walk test in IG only. Variables such as health behaviours; health-related quality of life; motivation to change; mental health; demographics and socioeconomic characteristics are assessed with an electronic study questionnaire that submits all data to a patient database, which automatically provides instant feed-back on the patients' health status.
Cost-effectiveness of the intervention is evaluated continuously and the intermediate
- 3 - outcomes of the intervention are extrapolated by economic modelling. The first statistical analyses and compilation of results will be performed one year after inclusion of the first patient or when the IG and CA have included 60 and 30 eligible patients respectively. Discussion By helping patients to overcome practical, social and cultural obstacles and increase their internal motivation for physical activity we aim to improve their physical health in a long-term perspective. The targeted patients belong to a patient category that is supposed to benefit from increased physical activity in terms of improved physiological values, mental status and quality of life, decreased risk of complications and maybe a decreased need of medication.
- Conditions
- Motivation for Physical Activity
- Being tested
- Multi-professional team intervention with PAR, lifestyle brochure, Ordinary recommendations on health behaviours, lifestyle brochure
- Keywords
- Physical activity, Hypertension, Diabetes mellitus, Motivational interviewing
- Medical subject headings
- Motor Activity, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-professional team intervention with PAR, lifestyle brochureBehavioural
Multi-professional team intervention with PAR, lifestyle brochure
Ordinary recommendations on health behaviours, lifestyle brochureBehavioural
Ordinary recommendations on health behaviours, lifestyle brochure
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Multi-professional team intervention with PAR, lifestyle brochure Receives: Behavioral: Multi-professional team intervention with PAR, lifestyle brochure |
| Conventional treatment | Active comparator | Ordinary recommendations on health behaviours, lifestyle brochure Receives: Behavioral: Ordinary recommendations on health behaviours, lifestyle brochure |
| retrospective med history comparison | No intervention | Treatment as usual (retrospective data collection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
to examine whether an extended multi-professional PAR intervention, based on SDT, is effective in increasing and maintaining the self-reported physical activity level in patients with newly diagnosed type 2 diabetes or hypertension or both.
Measured: every 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 Aug 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motivation for Physical ActivityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187576
- Sponsor's protocol ID
- CPF FaR 001
- Acronym
- DALICO
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2010
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-professional Team Intervention on Physical Activity Referrals in Primary Care Patients With Cardiovascular Risk factors-the Dalby Lifestyle Intervention Cohort Study (DALICO) Study
- ClinicalTrials.gov ID
- NCT01187576
- Acronym / sponsor ID
- DALICO / CPF FaR 001
- Conditions
- Motivation for Physical Activity
- Keywords
- Physical activity, Hypertension, Diabetes mellitus, Motivational interviewing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Study start
- Nov 2010 (actual)
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 24 Aug 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.
Background The present study protocol describes the trial design of a primary care intervention cohort study, which examines whether an extended, multi-professional physical activity referral (PAR) intervention is more effective in enhancing and maintaining self-reported physical activity than ordinary physical activity recommendations. The study targets patients with newly diagnosed hypertension and/or type 2 diabetes.
Secondary outcomes include: need of pharmacological therapy; blood pressure/plasma glucose; physical fitness and anthropometric variables; mental health; health related quality of life; and cost-effectiveness. Methods/Design The study is designed as a long-term intervention. Three primary care centres are involved in the study, each constituting one of three treatment groups: 1) Intervention group (IG): multi-professional team intervention with PAR, lifestyle brochure; 2) Control group A (CA): ordinary recommendations on health behaviours, lifestyle brochure; and 3) Control group B: treatment as usual (retrospective data collection).
The intervention is based on self-determination theory and follows the principles of motivational interviewing. Physical activity is measured with the International Physical Activity Questionnaire (IPAQ) and expressed as metabolic equivalent of task (MET)-minutes per week. Physical fitness is estimated with the 6-minute walk test in IG only. Variables such as health behaviours; health-related quality of life; motivation to change; mental health; demographics and socioeconomic characteristics are assessed with an electronic study questionnaire that submits all data to a patient database, which automatically provides instant feed-back on the patients' health status.
Cost-effectiveness of the intervention is evaluated continuously and the intermediate
- 3 - outcomes of the intervention are extrapolated by economic modelling. The first statistical analyses and compilation of results will be performed one year after inclusion of the first patient or when the IG and CA have included 60 and 30 eligible patients respectively. Discussion By helping patients to overcome practical, social and cultural obstacles and increase their internal motivation for physical activity we aim to improve their physical health in a long-term perspective. The targeted patients belong to a patient category that is supposed to benefit from increased physical activity in terms of improved physiological values, mental status and quality of life, decreased risk of complications and maybe a decreased need of medication.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Multi-professional team intervention with PAR, lifestyle brochureMulti-professional team intervention with PAR, lifestyle brochure |
| Conventional treatment | Active comparator | Behavioral: Ordinary recommendations on health behaviours, lifestyle brochureOrdinary recommendations on health behaviours, lifestyle brochure |
| retrospective med history comparison | No intervention | –Treatment as usual (retrospective data collection) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Multi-professional team intervention with PAR, lifestyle brochureMulti-professional team intervention with PAR, lifestyle brochure | Behavioural | Intervention |
| Ordinary recommendations on health behaviours, lifestyle brochureOrdinary recommendations on health behaviours, lifestyle brochure | Behavioural | Conventional treatment |
Primary outcome
to examine whether an extended multi-professional PAR intervention, based on SDT, is effective in increasing and maintaining the self-reported physical activity level in patients with newly diagnosed type 2 diabetes or hypertension or both.
Time frame: every 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-professional team intervention with PAR, lifestyle brochure and Ordinary recommendations on health behaviours, lifestyle brochure in people with Motivation for Physical Activity, run by Region Skane at 1 site in Sweden.
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 0 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: withdrawn, as of the sponsor's last update on 9 Aug 2018. 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 Sweden. 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 was withdrawn before enrolling participants, so there are no results.
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?
to examine whether an extended multi-professional PAR intervention, based on SDT, is effective in increasing and maintaining the self-reported physical activity level in patients with newly diagnosed type 2 diabetes or hypertension or both. (time frame: every 6 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 9 Aug 2018.