Impaired HealthLOFUSNCT02482896
The Lolland-Falster Health Study
An observational study of Impaired Health and Disease, run by Region Sjælland at 1 site in Denmark.
Trial summary
The study is a epidemiological, cross-sectional study in a mainly rural area of Denmark in Denmark. Life expectancy is shorter, morbidity is higher, and social problems more prevalent than in the urban areas of the country. Read more about this study
- Who is it for?
- Ages Up to 110 years
- Conditions the study is for
- Impaired Health, Disease, Wellbeing
- How many people
- 25,000 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population of Lolland and Guldborgsund municipalities in Denmark.
Who may be able to join
- Individuals registered in Lolland or Guldborgsund municipality
Who cannot join
- Adults with incapacity guardianship
- Incapacity to give informed consent
- Individuals with address protection
- Severe physical immobility
- Non-Danish and Non-English speaking
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
The Lolland-Falster Health Study
Nykøbing Falster, Region Sjælland, 4800
Randi Jepsen, Ph.d., +4556516856, rjep@regionsjaelland.dk
Birgitte Lundberg, MSc, +4556516858, blun@regionsjaelland.dk
About this study
The study is a epidemiological, cross-sectional study in a mainly rural area of Denmark in Denmark. Life expectancy is shorter, morbidity is higher, and social problems more prevalent than in the urban areas of the country. The population study aims at examining complexities of environmental, hereditary, lifestyle, and social factors as determinants and predisposing factors for morbidity, health, and quality of life. The study will cover physical, mental, and social dimensions and examine family patterns and subgroups. The study will provide baseline information for later follow-up.
- Conditions
- Impaired Health, Disease, Wellbeing, Mental Disorders, Atherosclerosis, Renal Insufficiency, Chronic
- Medical subject headings
- Disease, Mental Disorders, Atherosclerosis, Renal Insufficiency, Chronic, Skin Diseases, Urinary Incontinence, Coronary Disease, Ear Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Health
Self-administered questionnaires, clinical examination, and biospecimen
Measured: Cross-sectional, measured once
Secondary outcomes (2)
Morbidity
Self-administered questionnaires, clinical examination, and biospecimen
Measured: Cross-sectional, measured once
Risk factors
Self-administered questionnaires, clinical examination, and biospecimen
Measured: Cross-sectional, measured once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startFeb 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Impaired HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Sjælland
- Sponsor type
- University, hospital or other
- Collaborators
- Lolland Municipality, Denmark, Guldborgsund Municipality, Denmark
- Responsible party
- Sponsor
- Investigators
- Knud Rasmussen, Dr. Med., MD, Principal investigator, Region Sjælland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482896
- Sponsor's protocol ID
- SJ-421
- Acronym
- LOFUS
- Status last verified
- Jun 2016
- First submitted
- 1 Jun 2015
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mortensen SR, Brond JC, Petersen TL, Jepsen R, Dominguez-Navarro F, Skou ST, Grontved A. Association of Device-Measured Habitual Sedentary Activity and Standing Posture With Blood Pressure and Hypertension in Danish Adults: The Lolland-Falster Health Study. J Am Heart Assoc. 2025 Aug 19;14(16):e039133. doi: 10.1161/JAHA.124.039133. Epub 2025 Aug 18.
PubMed 40820973Bruun-Rasmussen NE, Napolitano G, Bojesen SE, Ellervik C, Holmager TLF, Rasmussen K, Lynge E. Correlation between allostatic load index and cumulative mortality: a register-based study of Danish municipalities. BMJ Open. 2024 Feb 12;14(2):e075697. doi: 10.1136/bmjopen-2023-075697.
PubMed 38346879Mortensen SR, Skou ST, Brond JC, Ried-Larsen M, Petersen TL, Jorgensen LB, Jepsen R, Tang LH, Bruun-Rasmussen NE, Grontved A. Detailed descriptions of physical activity patterns among individuals with diabetes and prediabetes: the Lolland-Falster Health Study. BMJ Open Diabetes Res Care. 2023 Sep;11(5):e003493. doi: 10.1136/bmjdrc-2023-003493.
PubMed 37699719Gronlund C, Djurhuus BD, Holm EA, Homoe P. Self-reported dizziness, falls, and self-rated health in a rural population in Denmark. Eur Arch Otorhinolaryngol. 2023 Dec;280(12):5329-5337. doi: 10.1007/s00405-023-08061-2. Epub 2023 Jul 8.
PubMed 37420013Sondergaard E, Reventlow S, Siersma V, Nicolaisdottir DR, Jepsen R, Rasmussen K, Moller A. A cross-sectional study of the association between family conflicts and children's health: Lolland-Falster Health Study. Child Care Health Dev. 2023 Nov;49(6):972-984. doi: 10.1111/cch.13108. Epub 2023 Feb 28.
PubMed 36805605Petersen TL, Brond JC, Kristensen PL, Aadland E, Grontved A, Jepsen R. Resemblance in Physical Activity in Families with Children in Time Segments during the Week: The Lolland-Falster Health Study. Med Sci Sports Exerc. 2021 Nov 1;53(11):2283-2289. doi: 10.1249/MSS.0000000000002718.
PubMed 34107506Jacobsen KK, Jepsen R, Lembeck MA, Nilsson C, Holm E. Associations between the SHARE frailty phenotype and common frailty characteristics: evidence from a large Danish population study. BMJ Open. 2019 Oct 15;9(10):e032597. doi: 10.1136/bmjopen-2019-032597.
PubMed 31619433Jepsen R, Egholm CL, Brodersen J, Simonsen E, Grarup J, Cyron A, Ellervik C, Rasmussen K. Lolland-Falster Health Study: Study protocol for a household-based prospective cohort study. Scand J Public Health. 2020 Jun;48(4):382-390. doi: 10.1177/1403494818799613. Epub 2018 Sep 17.
PubMed 30222051
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lolland-Falster Health Study
- ClinicalTrials.gov ID
- NCT02482896
- Acronym / sponsor ID
- LOFUS / SJ-421
- Conditions
- Impaired Health, Disease, Wellbeing, Mental Disorders, Atherosclerosis, Renal Insufficiency, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Region SjællandUniversity, hospital or other
- Collaborators
- Lolland Municipality, Denmark, Guldborgsund Municipality, Denmark
- Study start
- Feb 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a epidemiological, cross-sectional study in a mainly rural area of Denmark in Denmark. Life expectancy is shorter, morbidity is higher, and social problems more prevalent than in the urban areas of the country. The population study aims at examining complexities of environmental, hereditary, lifestyle, and social factors as determinants and predisposing factors for morbidity, health, and quality of life. The study will cover physical, mental, and social dimensions and examine family patterns and subgroups. The study will provide baseline information for later follow-up.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population of Lolland and Guldborgsund municipalities in Denmark.
Key inclusion criteria (1 listed)
- Individuals registered in Lolland or Guldborgsund municipality
Key exclusion criteria (5 listed)
- Adults with incapacity guardianship
- Incapacity to give informed consent
- Individuals with address protection
- Severe physical immobility
- Non-Danish and Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health
Time frame: Cross-sectional, measured once
Self-administered questionnaires, clinical examination, and biospecimen
2 secondary outcomes
Morbidity
Time frame: Cross-sectional, measured once
Risk factors
Time frame: Cross-sectional, measured once
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Derived from this study: PubMed 40820973Mortensen SR, Brond JC, Petersen TL, Jepsen R, Dominguez-Navarro F, Skou ST, Grontved A. Association of Device-Measured Habitual Sedentary Activity and Standing Posture With Blood Pressure and Hypertension in Danish Adults: The Lolland-Falster Health Study. J Am Heart Assoc. 2025 Aug 19;14(16):e039133. doi: 10.1161/JAHA.124.039133. Epub 2025 Aug 18.
- Derived from this study: PubMed 38346879Bruun-Rasmussen NE, Napolitano G, Bojesen SE, Ellervik C, Holmager TLF, Rasmussen K, Lynge E. Correlation between allostatic load index and cumulative mortality: a register-based study of Danish municipalities. BMJ Open. 2024 Feb 12;14(2):e075697. doi: 10.1136/bmjopen-2023-075697.
- Derived from this study: PubMed 37699719Mortensen SR, Skou ST, Brond JC, Ried-Larsen M, Petersen TL, Jorgensen LB, Jepsen R, Tang LH, Bruun-Rasmussen NE, Grontved A. Detailed descriptions of physical activity patterns among individuals with diabetes and prediabetes: the Lolland-Falster Health Study. BMJ Open Diabetes Res Care. 2023 Sep;11(5):e003493. doi: 10.1136/bmjdrc-2023-003493.
- Derived from this study: PubMed 37420013Gronlund C, Djurhuus BD, Holm EA, Homoe P. Self-reported dizziness, falls, and self-rated health in a rural population in Denmark. Eur Arch Otorhinolaryngol. 2023 Dec;280(12):5329-5337. doi: 10.1007/s00405-023-08061-2. Epub 2023 Jul 8.
- Derived from this study: PubMed 36805605Sondergaard E, Reventlow S, Siersma V, Nicolaisdottir DR, Jepsen R, Rasmussen K, Moller A. A cross-sectional study of the association between family conflicts and children's health: Lolland-Falster Health Study. Child Care Health Dev. 2023 Nov;49(6):972-984. doi: 10.1111/cch.13108. Epub 2023 Feb 28.
- Derived from this study: PubMed 34107506Petersen TL, Brond JC, Kristensen PL, Aadland E, Grontved A, Jepsen R. Resemblance in Physical Activity in Families with Children in Time Segments during the Week: The Lolland-Falster Health Study. Med Sci Sports Exerc. 2021 Nov 1;53(11):2283-2289. doi: 10.1249/MSS.0000000000002718.
- Derived from this study: PubMed 31619433Jacobsen KK, Jepsen R, Lembeck MA, Nilsson C, Holm E. Associations between the SHARE frailty phenotype and common frailty characteristics: evidence from a large Danish population study. BMJ Open. 2019 Oct 15;9(10):e032597. doi: 10.1136/bmjopen-2019-032597.
- Derived from this study: PubMed 30222051Jepsen R, Egholm CL, Brodersen J, Simonsen E, Grarup J, Cyron A, Ellervik C, Rasmussen K. Lolland-Falster Health Study: Study protocol for a household-based prospective cohort study. Scand J Public Health. 2020 Jun;48(4):382-390. doi: 10.1177/1403494818799613. Epub 2018 Sep 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knud Rasmussen, Dr. Med., MD principal investigator
Region Sjælland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impaired Health and Disease, run by Region Sjælland at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Randi Jepsen, PhD, MSc, RN (+4556516856, rjep@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health (time frame: Cross-sectional, measured once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02482896, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.