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Prevention of lifestyle-related disorders with early examinations of health and function and individualised functional profiles - a randomised controlled trial

NCT ID NCT06309342

NEW Sponsor: Lena Bornhoft Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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 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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

39 to 40 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Motor Activity psychiatric disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lifestyle-related condition

Contacts and locations

Locations

  • Capio Vårdcentral/Rehab Kvillebäcken

    Gothenburg, Sweden

  • Familjeläkarna i Mölnlycke

    Mölnlycke, Region Västra Götaland, 43544, Sweden

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