Prevention of Lifestyle-related Disorders Based on Functional Examinations
ConditionLifestyle-related Condition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age39-40
SponsorLena Bornhoft
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
PREVFUNKTION
Other interventionFunctional profile and advice concerning cardiovascular fitness level, strength, mobility, balance and posture. Motivational interview and support in goalsetting to make lifestyle changes.
Control
Other interventionPhysical activity measured with accelerometers. Functional examination. Medical examination and advice concerning weight measures, blood pressure and standard blood tests.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: PREVFUNKTIONExperimental treatment 2 interventions
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in objectively measured physical activity
Mean daily minutes in moderate-to-very vigorous physical activity measured with accelerometers for 1 week
Time frame
Change between baseline and 1-year follow-up2
Change in objectively measured sedentary behaviour
Mean daily minutes of sedentary behaviour measured with accelerometers for 1 week
Time frame
Change between baseline and 1-year follow-upSecondary outcomes
1
Change in cardiovascular fitness
Fitness level measured in ml/kg/min using the Ekblom Bak submaximal ergometer test
Time frame
Change between baseline and 1-year follow-up2
Change in motivation level
Motivation to make lifestyle changes to improve health on an 11-point numerical rating scale.
Time frame
Change between baseline and 1-year follow-up3
Proportion achieved goals
Proportion of goals achieved of the goals set by the intervention group at baseline
Time frame
Measured only at 1-year follow-up4
Change in fitness level
Point level on the study-specific functional profile arm for fitness where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better fitness level.
Time frame
Change between baseline and 1-year follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lena Bornhoft
Lead sponsor
Göteborg University
Sponsor institution
Vastra Gotaland Region
Collaborator
Göteborg University
Collaborator
Source ClinicalTrials.gov