Prevention of Lifestyle-related Disorders Based on Functional Examinations (PREVFUNKTION)

Lena Bornhoft

Status: Enrolling

Conditions: Lifestyle-related Condition

Treatments: Other: Control; Other: PREVFUNKTION

Study type: Interventional

Funder types: Other

Identifiers

NCT06309342

VGRFOU-278257

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 39 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

PREVFUNKTION

Experimental group

Description:

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.

Treatment:

Other: PREVFUNKTION

Other: Control

Control

Active Comparator group

Description:

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

Treatment:

Other: Control