Prevention of Lifestyle-related Disorders Based on Functional Examinations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-19

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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

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Lifestyle-related Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Investigators performing the health and function examinations will not be informed about the group to which the participant is allocated. All examinations are performed identically for participants from both groups.

Study Groups

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PREVFUNKTION

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.

Group Type EXPERIMENTAL

PREVFUNKTION

Intervention Type OTHER

Functional profile and advice concerning cardiovascular fitness level, strength, mobility, balance and posture. Motivational interview and support in goalsetting to make lifestyle changes.

Control

Intervention Type OTHER

Physical activity measured with accelerometers. Functional examination. Medical examination and advice concerning weight measures, blood pressure and standard blood tests.

Control

Medical examination. Functional examination. Measurement of physical activity. Questionnaires on health, function and lifestyle. Feedback and advice based on medical examination.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Physical activity measured with accelerometers. Functional examination. Medical examination and advice concerning weight measures, blood pressure and standard blood tests.

Interventions

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PREVFUNKTION

Functional profile and advice concerning cardiovascular fitness level, strength, mobility, balance and posture. Motivational interview and support in goalsetting to make lifestyle changes.

Intervention Type OTHER

Control

Physical activity measured with accelerometers. Functional examination. Medical examination and advice concerning weight measures, blood pressure and standard blood tests.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

39 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes