Clinical trial NCT06309342: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lifestyle-related Condition
Keywords: Lifestyle
Prevention
Physical activity
Fitness
Health examination
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
name: Göteborg University
First posted: 2024-03-13
Enrollment: 250
Sex: ALL
Minimum age (years): 39
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

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.

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.

Primary outcomes:
measure: Change in objectively measured physical activity
timeFrame: Change between baseline and 1-year follow-up
measure: Change in objectively measured sedentary behaviour
timeFrame: Change between baseline and 1-year follow-up
Secondary outcomes:
measure: Change in cardiovascular fitness
timeFrame: Change between baseline and 1-year follow-up
measure: Change in motivation level
timeFrame: Change between baseline and 1-year follow-up
measure: Proportion achieved goals
timeFrame: Measured only at 1-year follow-up
measure: Change in fitness level
timeFrame: Change between baseline and 1-year follow-up
measure: Change in strength upper extremity
timeFrame: Change between baseline and 1-year follow-up
measure: Change in strength lower extremity
timeFrame: Change between baseline and 1-year follow-up
measure: Change in strength trunk muscles
timeFrame: Change between baseline and 1-year follow-up
measure: Change in balance
timeFrame: Change between baseline and 1-year follow-up
measure: Change in mobility
timeFrame: Change between baseline and 1-year follow-up
measure: Change in posture
timeFrame: Change between baseline and 1-year follow-up
measure: Change in weight measures
timeFrame: Change between baseline and 1-year follow-up
measure: Change in pain
timeFrame: Change between baseline and 1-year follow-up
measure: Change in physical activity
timeFrame: Change between baseline and 1-year follow-up
measure: Change in handgrip strength
timeFrame: Change between baseline and 1-year follow-up
measure: Change in biceps strength
timeFrame: Change between baseline and 1-year follow-up
measure: Change in leg strength
timeFrame: Change between baseline and 1-year follow-up
measure: Change in calf strength
timeFrame: Change between baseline and 1-year follow-up
measure: Change in ventral trunk strength
timeFrame: Change between baseline and 1-year follow-up
measure: Change in dorsal trunk strength
timeFrame: Change between baseline and 1-year follow-up
measure: Change in lower trunk strength
timeFrame: Change between baseline and 1-year follow-up
measure: Change in static balance - 1
timeFrame: Change between baseline and 1-year follow-up
measure: Change in static balance - 2
timeFrame: Change between baseline and 1-year follow-up
measure: Change in static balance - 3
timeFrame: Change between baseline and 1-year follow-up
measure: Change in dynamic balance
timeFrame: Change between baseline and 1-year follow-up
measure: Change in mobility - 1
timeFrame: Change between baseline and 1-year follow-up
measure: Change in mobility - 2
timeFrame: Change between baseline and 1-year follow-up
measure: Change in mobility - 3
timeFrame: Change between baseline and 1-year follow-up
measure: Change in hypermobility score
timeFrame: Change between baseline and 1-year follow-up
measure: Change in neck mobility
timeFrame: Change between baseline and 1-year follow-up
measure: Change in foot pronation
timeFrame: Change between baseline and 1-year follow-up
measure: Change in habitual stance
timeFrame: Change between baseline and 1-year follow-up
measure: Change in health-related quality of life assessed with EQ5D index
timeFrame: Change between baseline and 1-year follow-up
measure: Change in health-related quality of life assessed with EQ5D VAS
timeFrame: Change between baseline and 1-year follow-up
measure: Change in self-reported physical activity assessed with Swedish questionnaire
timeFrame: Change between baseline and 1-year follow-up
measure: Change in self-reported physical activity assessed with Saltin Grimby Physical Activity Level Scale (SGPALS)
timeFrame: Change between baseline and 1-year follow-up
measure: Change in self-reported sedentary time
timeFrame: Change between baseline and 1-year follow-up
measure: Change in risk for chronic pain and sickness absence assessed with Örebro Musculoskeletal Pain Screening Questionnaire
timeFrame: Change between baseline and 1-year follow-up
measure: Change in number of pain locations
timeFrame: Change between baseline and 1-year follow-up
measure: Change in proportion smokers
timeFrame: Change between baseline and 1-year follow-up
measure: Change in proportion acceptable level blood glucose
timeFrame: Change between baseline and 1-year follow-up
measure: Change in proportion acceptable level serum cholesterol
timeFrame: Change between baseline and 1-year follow-up
measure: Change in proportion acceptable level triglycerides
timeFrame: Change between baseline and 1-year follow-up
measure: Change in proportion acceptable blood pressure
timeFrame: Change between baseline and 1-year follow-up
measure: Change in proportion normal body mass index (BMI)
timeFrame: Change between baseline and 1-year follow-up
measure: Change in proportion acceptable waist circumference
timeFrame: Change between baseline and 1-year follow-up
measure: Change in stress symptoms assessed with Stress and Crisis Inventory-93
timeFrame: Change between baseline and 1-year follow-up
measure: Change in depression and anxiety symptoms assessed with Hospital Anxiety and Depression Scale
timeFrame: Change between baseline and 1-year follow-up
measure: Correlation between self-assessed and objectively measured fitness
timeFrame: Change between baseline and 1-year follow-up
measure: Correlation between self-assessed and objectively measured fitness - 2
timeFrame: Change between baseline and 1-year follow-up
measure: Correlation between self-assessed and objectively measured strength upper extremity
timeFrame: Change between baseline and 1-year follow-up
measure: Correlation between self-assessed and objectively measured strength lower extremity
timeFrame: Change between baseline and 1-year follow-up
measure: Correlation between self-assessed and objectively measured balance
timeFrame: Change between baseline and 1-year follow-up
measure: Correlation between self-assessed and objectively measured physical activity
timeFrame: Change between baseline and 1-year follow-up
measure: Correlation between self-assessed and objectively measured physical activity - 2
timeFrame: Change between baseline and 1-year follow-up
measure: Change in relative physical activity
timeFrame: Change between baseline and 1-year follow-up
measure: Change in sufficient physical activity
timeFrame: Change between baseline and 1-year follow-up
Other outcomes:
Locations:
city: Mölnlycke
country: Sweden
facility: Familjeläkarna i Mölnlycke
state: Region Västra Götaland
Study officials:
affiliation: Region Västra Götaland, University of Gothenburg
name: Lena Bornhöft, PhD
role: PRINCIPAL_INVESTIGATOR
References: