Lifestyle-related ConditionPREVFUNKTIONNCT06309342
Prevention of Lifestyle-related Disorders Based on Functional Examinations
A study testing PREVFUNKTION in people with Lifestyle-related Condition, run by Lena Bornhoft at 2 sites in Sweden.
Trial summary
The goal of this randomised controlled trial is to examine the effects of functional examinations and feedback/support on healthy 40-year-olds. The main questions it aims to answer are: • Does feedback and motivational interviewing after testing physical function motivate inactive middle-aged people to increase their… Read more about this study
- Who is it for?
- Ages 39 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Lifestyle-related Condition
- What is being tested?
- PREVFUNKTION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesSweden
- Study dates
- 28 Aug 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 39 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 40 years of age
- Relatively normal general mobility - can walk without support and have no self-reported difficulties with using all four extremities - in order to be able to perform standardised functional performance tests.
- Self-assessed as physically inactive (level 1 or 2 on the Saltin Grimby Physical Activity Level Scale) as inactive people stand to gain most from this intervention.
Who cannot join
- Verbally self-reported physical activity at level three or four on Saltin Grimby Physical Activity Level Scale.
- Severe mental illness or intellectual impairment, as participants will be expected to fill out questionnaires and should have the ability to follow healthcare advice independently should they choose to do so.
- Pregnancy and/or on-going treatment requiring hospital-based services, to increase probability of baseline values which reflect usual capacity.
- No language restrictions are planned but participants needing interpreter help should arrange this themselves.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Capio Vårdcentral/Rehab Kvillebäcken
Gothenburg
Familjeläkarna i Mölnlycke
Mölnlycke, Region Västra Götaland, 43544
About this study
Official title: Prevention of Lifestyle-related Disorders With Early Examinations of Health and Function and Individualised Functional Profiles - a Randomised Controlled Trial
The goal of this randomised controlled trial is to examine the effects of functional examinations and feedback/support on healthy 40-year-olds. The main questions it aims to answer are: • Does feedback and motivational interviewing after testing physical function motivate inactive middle-aged people to increase their physical activity level? • Does the intervention lead to health benefits over time - less pain, better function, higher health-related quality of life, fewer risk factors for lifestyle-related illness? Participants will: • undergo medical and functional health examinations, • their physical activity level will be measured, • receive feedback and advice based on both parts of the examinations, • receive a functional profile, • be supported in goalsetting for lifestyle changes. Researchers will compare with a control group who, after the examinations, receive feedback only from the medical examination to see if participants become more physically active, achieve better function, become more motivated to make lifestyle changes, reduce risk factors for lifestyle-related illness, achieve health benefits and better health-related quality of life.
Read the detailed description
Relatively healthy 40-year-olds will be examined at baseline and 1 year with both standard medical and newly developed functional examinations and physical activity level will be measured with accelerometers. The intervention group will receive feedback on all their results. A functional profile will be compiled and explained to each participant and they will receive support in setting relevant goals for lifestyle changes and making realistic plans to achieve them. The control group will also be examined as above but will receive feedback and advice based only on the standard medical examination.
- Conditions
- Lifestyle-related Condition
- Being tested
- PREVFUNKTION, Control
- Keywords
- Lifestyle, Prevention, Physical activity, Fitness, Health examination
- Medical subject headings
- Mental Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREVFUNKTIONOther
Functional profile and advice concerning cardiovascular fitness level, strength, mobility, balance and posture. Motivational interview and support in goalsetting to make lifestyle changes.
ControlOther
Physical activity measured with accelerometers. Functional examination. Medical examination and advice concerning weight measures, blood pressure and standard blood tests.
| Study group | Role | What they receive |
|---|---|---|
| PREVFUNKTION | Experimental | Medical examination. Functional examination. Measurement of physical activity. Questionnaires on health, function and lifestyle. Feedback and advice based on medical examination. Feedback and advice based on functional examination. Functional profile. Support in setting goals for lifestyle changes. Receives: Other: PREVFUNKTION; Other: Control |
| Control | Active comparator | Medical examination. Functional examination. Measurement of physical activity. Questionnaires on health, function and lifestyle. Feedback and advice based on medical examination. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in objectively measured physical activity
Mean daily minutes in moderate-to-very vigorous physical activity measured with accelerometers for 1 week
Measured: Change between baseline and 1-year follow-up
Change in objectively measured sedentary behaviour
Mean daily minutes of sedentary behaviour measured with accelerometers for 1 week
Measured: Change between baseline and 1-year follow-up
Secondary outcomes (56)
Change in cardiovascular fitness
Fitness level measured in ml/kg/min using the Ekblom Bak submaximal ergometer test
Measured: Change between baseline and 1-year follow-up
Change in motivation level
Motivation to make lifestyle changes to improve health on an 11-point numerical rating scale.
Measured: Change between baseline and 1-year follow-up
Proportion achieved goals
Proportion of goals achieved of the goals set by the intervention group at baseline
Measured: Measured only at 1-year follow-up
Change in fitness level
Point level on the study-specific functional profile arm for fitness where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better fitness level.
Measured: Change between baseline and 1-year follow-up
Change in strength upper extremity
Point level on the study-specific functional profile arm for strength upper extremity where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better strength.
Measured: Change between baseline and 1-year follow-up
Change in strength lower extremity
Point level on the study-specific functional profile arm for strength lower extremity where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better strength.
Measured: Change between baseline and 1-year follow-up
Change in strength trunk muscles
Point level on the study-specific functional profile arm for strength trunk where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better strength.
Measured: Change between baseline and 1-year follow-up
Change in balance
Point level on the study-specific functional profile arm for balance where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better balance.
Measured: Change between baseline and 1-year follow-up
Change in mobility
Point level on the study-specific functional profile arm for mobility where points are given for grade of deviation from norm. Minimum -2, maximum 0. Lower score indicates mobility dysfunction, 0 indicates normal mobility.
Measured: Change between baseline and 1-year follow-up
Change in posture
Point level on the study-specific functional profile arm for posture where points are given for grade of deviation from norm. Minimum -1, maximum 0. Lower score indicates postural deviations, 0 indicates normal postural measurements.
Measured: Change between baseline and 1-year follow-up
Change in weight measures
Point level on the study-specific functional profile arm for weight where points are given for grade of deviation from recommended values. Minimum -2, maximum 0. Lower score indicates overweight (or underweight), 0 indicates normal weight.
Measured: Change between baseline and 1-year follow-up
Change in pain
Point level on the study-specific functional profile arm for pain where points are given for number of pain locations, score on the Örebro Musculoskeletal Pain Screening Questionnaire and on the pain question on Euroqol-5 dimensions-3 levels. Minimum -2, maximum 0. Lower score indicates more pain, 0 indicates no pain.
Measured: Change between baseline and 1-year follow-up
Change in physical activity
Point level on the study-specific functional profile arm for physical activity where points are given for grade of deviation from recommended values when objectively measured with accelerometers. Minimum -2, maximum +2. Increased point value indicates higher physical activity level.
Measured: Change between baseline and 1-year follow-up
Change in handgrip strength
Measured with Jamar handdynamometer (kg)
Measured: Change between baseline and 1-year follow-up
Change in biceps strength
Measured with 30-second biceps test (number repetitions)
Measured: Change between baseline and 1-year follow-up
Change in leg strength
Measured with 30-second chair-stand test (number repetitions)
Measured: Change between baseline and 1-year follow-up
Change in calf strength
Measured with single-foot heel rises (number repetitions)
Measured: Change between baseline and 1-year follow-up
Change in ventral trunk strength
Measured with plank test (seconds)
Measured: Change between baseline and 1-year follow-up
Change in dorsal trunk strength
Measured with back endurance test (seconds)
Measured: Change between baseline and 1-year follow-up
Change in lower trunk strength
Measured with supine bridge test (seconds)
Measured: Change between baseline and 1-year follow-up
Change in static balance - 1
Measured with stand-on-one-leg-eyes-open test (seconds)
Measured: Change between baseline and 1-year follow-up
Change in static balance - 2
Measured with stand-on-one-leg-eyes-closed test (seconds)
Measured: Change between baseline and 1-year follow-up
Change in static balance - 3
Measured with sharpened Romberg test (seconds)
Measured: Change between baseline and 1-year follow-up
Change in dynamic balance
Measured with functional reach test (centimeters)
Measured: Change between baseline and 1-year follow-up
Change in mobility - 1
Measured with sit-rise test (points)
Measured: Change between baseline and 1-year follow-up
Change in mobility - 2
Measured with finger-floor test (centimeters)
Measured: Change between baseline and 1-year follow-up
Change in mobility - 3
Measured with lateral flexion test (centimeters)
Measured: Change between baseline and 1-year follow-up
Change in hypermobility score
Measured with Beighton hypermobility score with point values between 0 and 9 where score over 4 indicate general hypermobility.
Measured: Change between baseline and 1-year follow-up
Change in neck mobility
Measured with occiput-to-wall test (points)
Measured: Change between baseline and 1-year follow-up
Change in foot pronation
Measured with navicular drop test (millimeters)
Measured: Change between baseline and 1-year follow-up
Change in habitual stance
Measured with patella mobility test (points)
Measured: Change between baseline and 1-year follow-up
Change in health-related quality of life assessed with EQ5D index
Measured with index values for Euroqol-5 dimensions-3 levels. Minimum -0.59, maximum +1. Higher scores indicate better health-related quality of life.
Measured: Change between baseline and 1-year follow-up
Change in health-related quality of life assessed with EQ5D VAS
Measured with the 100-point barometer for Euroqol-5 dimensions-3 levels. Minimum 0, maximum 100. Higher scores indicate better health-related quality of life.
Measured: Change between baseline and 1-year follow-up
Change in self-reported physical activity assessed with Swedish questionnaire
Measured with Swedish National Board of Health and Welfare questionnaire with 2 questions on physical activity and exercise measured in minutes. Minimum 0, maximum measured value 540. Increasing values indicate higher levels of physical activity.
Measured: Change between baseline and 1-year follow-up
Change in self-reported physical activity assessed with Saltin Grimby Physical Activity Level Scale (SGPALS)
Measured with SGPALS with point values between 1 and 4 where increasing values indicate higher level of physical activity.
Measured: Change between baseline and 1-year follow-up
Change in self-reported sedentary time
Measured in hours per day with SED-GIH questionnaire with values between 0 and 24 where increasing sedentary time is considered to have a negative impact on health.
Measured: Change between baseline and 1-year follow-up
Change in risk for chronic pain and sickness absence assessed with Örebro Musculoskeletal Pain Screening Questionnaire
Measured with Örebro Musculoskeletal Pain Screening Questionnaire with scores between 1 and 100 where increasing values indicate higher risk for chronic pain and sickness absence.
Measured: Change between baseline and 1-year follow-up
Change in number of pain locations
Measured with a pain diagram
Measured: Change between baseline and 1-year follow-up
Change in proportion smokers
Proportion smokers in each group
Measured: Change between baseline and 1-year follow-up
Change in proportion acceptable level blood glucose
Proportion with blood glucose levels within recommended limits (4.0-6.0 mmol/L)
Measured: Change between baseline and 1-year follow-up
Change in proportion acceptable level serum cholesterol
Proportion with cholesterol levels within recommended limits (3.3-6.9 mmol/L)
Measured: Change between baseline and 1-year follow-up
Change in proportion acceptable level triglycerides
Proportion with triglyceride levels within recommended limits (0,45-2.6)
Measured: Change between baseline and 1-year follow-up
Change in proportion acceptable blood pressure
Proportion of participants with blood pressure within recommended limits
Measured: Change between baseline and 1-year follow-up
Change in proportion normal body mass index (BMI)
Proportion of participants with BMI within recommended limits
Measured: Change between baseline and 1-year follow-up
Change in proportion acceptable waist circumference
Proportion of participants with waist circumference below recommended level
Measured: Change between baseline and 1-year follow-up
Change in stress symptoms assessed with Stress and Crisis Inventory-93
Measured with Stress and Crisis Inventory-93 questionnaire. Minimum 0, maximum 140, with higher values indicating higher stress levels.
Measured: Change between baseline and 1-year follow-up
Change in depression and anxiety symptoms assessed with Hospital Anxiety and Depression Scale
Measured with Hospital Anxiety and Depression Scale. Minimum 0, maximum 42 with 21 as maximum for anxiety and 21 maximum for depression. Increasing values indicate more severe symptoms.
Measured: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured fitness
Correlation between fitness self-assessed on a 5-point Likert scale and point value on the fitness arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Measured: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured fitness - 2
Correlation between fitness self-assessed on a 5-point Likert scale and fitness grade on the Ekblom Bak fitness test (5 point Likert scale). Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Measured: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured strength upper extremity
Correlation between upper extremity strength self-assessed on a 5-point Likert scale and point value for the strength upper extremity arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Measured: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured strength lower extremity
Correlation between lower extremity strength self-assessed on a 5-point Likert scale and point value for the strength lower extremity arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Measured: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured balance
Correlation between balance self-assessed on a 5-point Likert scale and point value on the balance arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Measured: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured physical activity
Correlation between self-assessed walking ability on a 5-point Likert scale and point value on the physical activity arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Measured: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured physical activity - 2
Correlation between self-assessed walking ability on a 5-point Likert scale and number of daily minutes in moderate-to-very vigorous physical activity measured with accelerometers. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Measured: Change between baseline and 1-year follow-up
Change in relative physical activity
Mean daily minutes of moderate-to-very vigorous physical activity measured with accelerometers for 1 week where moderate is individually calculated in relation to fitness level (46% of VO2max).
Measured: Change between baseline and 1-year follow-up
Change in sufficient physical activity
Number of mean daily minutes of physical activity measured with accelerometers for 1 week above a known health-promoting level based on a fitness level of 31.5 ml/kg for women and 35 ml/kg for men.
Measured: Change between baseline and 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start28 Aug 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle-related ConditionStudies 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
- Model description
- Initial examinations and data collection are made before randomisation. Randomisation then leads to the two groups of participants receiving different amounts of feedback and support. Follow-up examinations and data collection are made after one year in both groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lena Bornhoft
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region, Göteborg University
- Responsible party
- Sponsor-investigator, Lena Bornhoft, Göteborg University
- Investigators
- Lena Bornhöft, PhD, Principal investigator, Region Västra Götaland, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309342
- Sponsor's protocol ID
- VGRFOU-278257
- Acronym
- PREVFUNKTION
- Status last verified
- Sep 2026
- First submitted
- 29 Feb 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Lifestyle-related Disorders With Early Examinations of Health and Function and Individualised Functional Profiles - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06309342
- Acronym / sponsor ID
- PREVFUNKTION / VGRFOU-278257
- Conditions
- Lifestyle-related Condition
- Keywords
- Lifestyle, Prevention, Physical activity, Fitness, Health examination
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Lena BornhoftUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region, Göteborg University
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Mar 2024 (actual)
- 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 goal of this randomised controlled trial is to examine the effects of functional examinations and feedback/support on healthy 40-year-olds. The main questions it aims to answer are: • Does feedback and motivational interviewing after testing physical function motivate inactive middle-aged people to increase their physical activity level? • Does the intervention lead to health benefits over time - less pain, better function, higher health-related quality of life, fewer risk factors for lifestyle-related illness? Participants will: • undergo medical and functional health examinations, • their physical activity level will be measured, • receive feedback and advice based on both parts of the examinations, • receive a functional profile, • be supported in goalsetting for lifestyle changes. Researchers will compare with a control group who, after the examinations, receive feedback only from the medical examination to see if participants become more physically active, achieve better function, become more motivated to make lifestyle changes, reduce risk factors for lifestyle-related illness, achieve health benefits and better health-related quality of life.
Detailed description
Relatively healthy 40-year-olds will be examined at baseline and 1 year with both standard medical and newly developed functional examinations and physical activity level will be measured with accelerometers. The intervention group will receive feedback on all their results. A functional profile will be compiled and explained to each participant and they will receive support in setting relevant goals for lifestyle changes and making realistic plans to achieve them. The control group will also be examined as above but will receive feedback and advice based only on the standard medical examination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Initial examinations and data collection are made before randomisation. Randomisation then leads to the two groups of participants receiving different amounts of feedback and support. Follow-up examinations and data collection are made after one year in both groups.
| Arm | Type | Receives |
|---|---|---|
| PREVFUNKTION | Experimental | Other: PREVFUNKTION, Other: ControlMedical examination. Functional examination. Measurement of physical activity. Questionnaires on health, function and lifestyle. Feedback and advice based on medical examination. Feedback and advice based on functional examination. Functional profile. Support in setting goals for lifestyle changes. |
| Control | Active comparator | Other: ControlMedical examination. Functional examination. Measurement of physical activity. Questionnaires on health, function and lifestyle. Feedback and advice based on medical examination. |
Who may qualify
- Ages
- 39 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 40 years of age
- Relatively normal general mobility - can walk without support and have no self-reported difficulties with using all four extremities - in order to be able to perform standardised functional performance tests.
- Self-assessed as physically inactive (level 1 or 2 on the Saltin Grimby Physical Activity Level Scale) as inactive people stand to gain most from this intervention.
Key exclusion criteria (4 listed)
- Verbally self-reported physical activity at level three or four on Saltin Grimby Physical Activity Level Scale.
- Severe mental illness or intellectual impairment, as participants will be expected to fill out questionnaires and should have the ability to follow healthcare advice independently should they choose to do so.
- Pregnancy and/or on-going treatment requiring hospital-based services, to increase probability of baseline values which reflect usual capacity.
- No language restrictions are planned but participants needing interpreter help should arrange this themselves.
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 |
|---|---|---|
| PREVFUNKTIONFunctional profile and advice concerning cardiovascular fitness level, strength, mobility, balance and posture. Motivational interview and support in goalsetting to make lifestyle changes. | Other | PREVFUNKTION |
| ControlPhysical activity measured with accelerometers. Functional examination. Medical examination and advice concerning weight measures, blood pressure and standard blood tests. | Other | Control, PREVFUNKTION |
Primary outcome
Change in objectively measured physical activity
Time frame: Change between baseline and 1-year follow-up
Mean daily minutes in moderate-to-very vigorous physical activity measured with accelerometers for 1 week
Change in objectively measured sedentary behaviour
Time frame: Change between baseline and 1-year follow-up
Mean daily minutes of sedentary behaviour measured with accelerometers for 1 week
56 secondary outcomes
Change in cardiovascular fitness
Time frame: Change between baseline and 1-year follow-up
Change in motivation level
Time frame: Change between baseline and 1-year follow-up
Proportion achieved goals
Time frame: Measured only at 1-year follow-up
Change in fitness level
Time frame: Change between baseline and 1-year follow-up
Change in strength upper extremity
Time frame: Change between baseline and 1-year follow-up
Change in strength lower extremity
Time frame: Change between baseline and 1-year follow-up
Change in strength trunk muscles
Time frame: Change between baseline and 1-year follow-up
Change in balance
Time frame: Change between baseline and 1-year follow-up
Change in mobility
Time frame: Change between baseline and 1-year follow-up
Change in posture
Time frame: Change between baseline and 1-year follow-up
Change in weight measures
Time frame: Change between baseline and 1-year follow-up
Change in pain
Time frame: Change between baseline and 1-year follow-up
Change in physical activity
Time frame: Change between baseline and 1-year follow-up
Change in handgrip strength
Time frame: Change between baseline and 1-year follow-up
Change in biceps strength
Time frame: Change between baseline and 1-year follow-up
Change in leg strength
Time frame: Change between baseline and 1-year follow-up
Change in calf strength
Time frame: Change between baseline and 1-year follow-up
Change in ventral trunk strength
Time frame: Change between baseline and 1-year follow-up
Change in dorsal trunk strength
Time frame: Change between baseline and 1-year follow-up
Change in lower trunk strength
Time frame: Change between baseline and 1-year follow-up
Change in static balance - 1
Time frame: Change between baseline and 1-year follow-up
Change in static balance - 2
Time frame: Change between baseline and 1-year follow-up
Change in static balance - 3
Time frame: Change between baseline and 1-year follow-up
Change in dynamic balance
Time frame: Change between baseline and 1-year follow-up
Change in mobility - 1
Time frame: Change between baseline and 1-year follow-up
Change in mobility - 2
Time frame: Change between baseline and 1-year follow-up
Change in mobility - 3
Time frame: Change between baseline and 1-year follow-up
Change in hypermobility score
Time frame: Change between baseline and 1-year follow-up
Change in neck mobility
Time frame: Change between baseline and 1-year follow-up
Change in foot pronation
Time frame: Change between baseline and 1-year follow-up
Change in habitual stance
Time frame: Change between baseline and 1-year follow-up
Change in health-related quality of life assessed with EQ5D index
Time frame: Change between baseline and 1-year follow-up
Change in health-related quality of life assessed with EQ5D VAS
Time frame: Change between baseline and 1-year follow-up
Change in self-reported physical activity assessed with Swedish questionnaire
Time frame: Change between baseline and 1-year follow-up
Change in self-reported physical activity assessed with Saltin Grimby Physical Activity Level Scale (SGPALS)
Time frame: Change between baseline and 1-year follow-up
Change in self-reported sedentary time
Time frame: Change between baseline and 1-year follow-up
Change in risk for chronic pain and sickness absence assessed with Örebro Musculoskeletal Pain Screening Questionnaire
Time frame: Change between baseline and 1-year follow-up
Change in number of pain locations
Time frame: Change between baseline and 1-year follow-up
Change in proportion smokers
Time frame: Change between baseline and 1-year follow-up
Change in proportion acceptable level blood glucose
Time frame: Change between baseline and 1-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Lifestyle-related Condition
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Lena Bornhöft, PhD principal investigator
Region Västra Götaland, University of Gothenburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREVFUNKTION in people with Lifestyle-related Condition, run by Lena Bornhoft at 2 sites 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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 objectively measured physical activity (time frame: Change between baseline and 1-year follow-up). The study lists 2 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 9 Sep 2026.