Prevention of Lifestyle-related Disorders Based on Functional Examinations

Official title

Prevention of Lifestyle-related Disorders With Early Examinations of Health and Function and Individualised Functional Profiles - a Randomised Controlled Trial

Overview

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.

Interventions

• Other PREVFUNKTION
  Functional profile and advice concerning cardiovascular fitness level, strength, mobility, balance and posture. Motivational interview and support in goalsetting to make lifestyle changes.
• Other Control
  Physical activity measured with accelerometers. Functional examination. Medical examination and advice concerning weight measures, blood pressure and standard blood tests.

Primary outcome measures

• Change in objectively measured physical activity [Time frame: Change between baseline and 1-year follow-up]
• Change in objectively measured sedentary behaviour [Time frame: Change between baseline and 1-year follow-up]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Sweden · 1 center

• Familjeläkarna i Mölnlycke — Mölnlycke

Identifiers

NCT: NCT06309342 · VGRFOU-278257

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗