Preventing lifestyle-related disorders through functional examinations
Prevention of Lifestyle-related Disorders With Early Examinations of Health and Function and Individualised Functional Profiles - a Randomised Controlled Trial
This study is testing if giving personalized feedback and support after health check-ups can help relatively healthy 40-year-olds become more active and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 39 Years to 40 Years |
| Sex | All |
| Sponsor | Göteborg University Academic / other |
| Locations | 1 site (Mölnlycke, Region Västra Götaland) |
| Trial ID | NCT06309342 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to assess the impact of functional examinations and personalized feedback on the physical activity levels of relatively healthy 40-year-olds. Participants will undergo both medical and functional health assessments, with the intervention group receiving comprehensive feedback and support for lifestyle changes, while the control group will only receive feedback from medical examinations. The study will measure changes in physical activity, pain levels, functional ability, and overall health-related quality of life over one year. The goal is to determine if targeted feedback and motivational interviewing can effectively encourage inactive individuals to adopt healthier lifestyles.
Who should consider this trial
Good fit: Ideal candidates are relatively healthy individuals aged 40 who self-identify as physically inactive.
Not a fit: Patients who are already physically active or have severe mental illness or intellectual impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve physical activity levels and overall health outcomes for middle-aged individuals.
How similar studies have performed: Other studies have shown success with similar motivational and feedback-based approaches to increase physical activity among inactive populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mölnlycke, Region Västra Götaland
- Familjeläkarna i Mölnlycke — Mölnlycke, Region Västra Götaland, Sweden (Recruiting)
Study contacts
- Principal investigator: Lena Bornhöft, PhD — Region Västra Götaland, University of Gothenburg
- Study coordinator: Lena Bornhöft, PhD
- Email: lena.bornhoft@vgregion.se
- Phone: +46 761408320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.