Prevention of Lifestyle-related Ill-health With Early Functional Examinations and Individualized Risk Profiles

NCT ID: NCT05535296

Last Updated: 2023-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-04-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background: Many lifestyle-related health disorders are influenced by physical activity level and physical function. Health examinations which focus on musculoskeletal function of people who have risk factors for lifestyle-related disorders, combined with person-centered advice based on risk profiles can give people knowledge and guidance to manage their own lifestyle priorities.

Aim: To investigate the feasibility of a protocol for a randomized controlled trial (RCT) which will examine the preventive effects of musculoskeletal function examinations and person-centered advice on inactive middle-aged people.

Methods: Physically inactive middle-aged people will be invited to participate in a two-part health examination with follow-up after three months in a pilot study. Part 1 is a standard health examination including blood tests and Part 2 is a functional examination of fitness, strength, mobility, balance and posture according to our protocol based on validated tests. The intervention group receives feedback based on both parts of the examination while the control group receives feedback only from Part 1. Physical activity level will be measured objectively with accelerometers at inclusion and follow-up.

Expected results: The pilot study is expected to show whether the planned RCT is practically feasible and to give relevant support for the power analysis for a later full-scale RCT. Better understanding of personal physical function and risk factors can facilitate lifestyle decisions on the individual level which can reduce the risk for later ill-health and need of health-care. Preventive interventions may contribute to reduce the ever-increasing level of lifestyle-related ill-health.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lifestyle Risk Reduction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

Standard health examination and related feedback. Functional examination. Risk profile and related advice.

Group Type EXPERIMENTAL

Risk profile

Intervention Type BEHAVIORAL

Compiliation of risk profile based on fitness, strength, mobility, balance, posture, physical activity level, weight and pain. Advice based on the above and support in goal-setting.

Control group

Standard health examination and related feedback. Functional examination.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Risk profile

Compiliation of risk profile based on fitness, strength, mobility, balance, posture, physical activity level, weight and pain. Advice based on the above and support in goal-setting.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Born 1982 (aged 40 years). Self-assessed as physically inactive. Self-reported normal general mobility - can walk without support and has full use of all 4 extremities.

Exclusion Criteria

* Self-reported regular moderate-to-intensive physical activity more than once per week. Pregnancy. Ongoing treatment requiring hospital-based services. Severe mental illness or intellectual impairment. Need of interpreter to participate in the study or answer the questionnaires.
Minimum Eligible Age

39 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vastra Gotaland Region

OTHER_GOV

Sponsor Role collaborator

Region Värmland, Sweden

UNKNOWN

Sponsor Role collaborator

Lena Bornhoft

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lena Bornhoft

Physiotherapist, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lena Bornhöft, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Västra Götaland, University of Gothenburg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Närhälsan Biskopsgården Health centre

Gothenburg, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Bornhoft L, Arvidsson D, Bergenheim A, Borjesson M, Fridolfsson J, Hellgren M, Nordeman L, Larsson MEH. Function-based risk reduction intervention for lifestyle-related disorders among inactive 40-year-old people: a pilot randomised controlled trial. BMC Public Health. 2024 Oct 13;24(1):2799. doi: 10.1186/s12889-024-20301-6.

Reference Type DERIVED
PMID: 39396984 (View on PubMed)

Bornhoft L, Arvidsson D, Bergenheim A, Borjesson M, Fridolfsson J, Hellgren M, Nordeman L, Larsson ME. Development and feasibility of a function-based preventive intervention for lifestyle-related disorders. BMC Public Health. 2024 Mar 4;24(1):681. doi: 10.1186/s12889-024-18017-8.

Reference Type DERIVED
PMID: 38438859 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VGFOUREG-968488

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Lake Nona Life Project
NCT02533804 RECRUITING
The Ebeltoft Health Promotion Project
NCT00145782 COMPLETED PHASE3
Healthy Homes Study
NCT05833334 RECRUITING NA