Prevention of Lifestyle-related Disorders Based on Functional Examinations

NCT06309342 | Recruiting

• 1 other identifier: VGRFOU-278257
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lifestyle-related Condition

Keywords

Lifestyle; Prevention; Physical activity; Fitness; Health examination

Outcome Measures

Primary Outcomes (2)

• Change in objectively measured physical activity

  Mean daily minutes in moderate-to-very vigorous physical activity measured with accelerometers for 1 week

  Change between baseline and 1-year follow-up

• Change in objectively measured sedentary behaviour

  Mean daily minutes of sedentary behaviour measured with accelerometers for 1 week

  Change between baseline and 1-year follow-up

Secondary Outcomes (56)

• Change in cardiovascular fitness

  Change between baseline and 1-year follow-up

• Change in motivation level

  Change between baseline and 1-year follow-up

• Proportion achieved goals

  Measured only at 1-year follow-up

• Change in fitness level

  Change between baseline and 1-year follow-up

• Change in strength upper extremity

  Change between baseline and 1-year follow-up

Study Arms (2)

PREVFUNKTION

EXPERIMENTAL

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.

Other: PREVFUNKTION; Other: Control

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

PREVFUNKTION OTHER

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

PREVFUNKTION

Control OTHER

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

Control; PREVFUNKTION

Eligibility Criteria

• Age: 39 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lena Bornhoft: lead
• Vastra Gotaland Region: collaborator
• Göteborg University: collaborator

Study Sites (1)

Familjeläkarna i Mölnlycke

Mölnlycke, Region Västra Götaland, 43544, Sweden

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Lena Bornhöft, PhD

  Region Västra Götaland, University of Gothenburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena Bornhöft, PhD

CONTACT

+46 761408320; lena.bornhoft@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research and development leader

Model Details: 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.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 13, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)