Non-Communicable Chronic DiseasesINHLCSNCT05450406
The Inland Norway Healthy Life Center Study
A study testing Physical activity in people with Non-Communicable Chronic Diseases and Obesity, run by Inland Norway University of Applied Sciences.
Trial summary
Healthy Life Centers (Norwegian, 'Frisklivssentralen') is a municipal service in Norway that aims to promote both physical and mental health, as well as to limit the development of non-communicable diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Communicable Chronic Diseases, Obesity, Insulin Resistance
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Jul 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years of age
- Receiving follow-up from the Healthy Life Center
- >18 years of age
Who cannot join
- In average >1 weekly exercise training session the last three months
- Reference group
- In average >1 weekly exercise training session the last three months
- Receiving follow-up from the Healthy Life Center
Trial locations and contacts
No sites are listed yet.
About this study
Healthy Life Centers (Norwegian, 'Frisklivssentralen') is a municipal service in Norway that aims to promote both physical and mental health, as well as to limit the development of non-communicable diseases. Previous research has shown that receiving follow-up from Healthy Life Centers has led to higher levels of daily physical activity, in addition to improved self-reported health and quality of life among the participants. However, there is a lack of studies that have examined what kind of physiological health effects can be expected from participating in the Healthy Life Center's follow-up.
In this study, responses to the 12-week physical activity program of the Healthy Life Center will be compared with the responses in a negative control group that does not receive such follow-up. Both the intervention group and the reference group (the negative control group) will carry out the same tests and measurements before and after the 12 week period. The tests will include measurements of anthropometric variables (body height, body weight and waist circumference), body composition, arterial stiffness, resting blood pressure and blood variables (blood glucose, long-term blood glucose, blood lipid profile and inflammation markers), in addition to physical tests of mobility, balance, maximum aerobic capacity (maximal oxygen consumption) and maximum muscle strength. Questionnaires related to adherence to the Healthy Life Center follow-up, socio-demographic variables, eating and drinking habits, activity level, perceived physical fitness, motivation for exercise, and health-related quality of life will also be included.
- Conditions
- Non-Communicable Chronic Diseases, Obesity, Insulin Resistance, Musculoskeletal Diseases, Psychological Disorder, Cardiovascular Diseases
- Being tested
- Physical activity
- Medical subject headings
- Noncommunicable Diseases, Obesity, Insulin Resistance, Musculoskeletal Diseases, Mental Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
The participants will receive the possibility to attend weekly endurance, resistance and yoga exercise sessions administered by the Healthy Life Center. They will also receive personalized follow-up from the Healthy Life Center, and have the possibility to exercise at the local gym.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Participants in the intervention group will receive 12-week follow-up from the Healthy Life Center Receives: Other: Physical activity |
| Control group | No intervention | Participants in the intervention group will not receive follow-up from the Healthy Life Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen consumption (measured in mL/kg body mass/min)
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Secondary outcomes (16)
Balance, measured using the "single leg stance test" (measured in seconds)
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Mobility, measured using the "sit-and-reach" and the "back stretch" test (measured in centimeters)
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Fat mass (measured in kilograms)
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Lean mass (measured in kilograms)
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Bone mineral density ( measured in g/cm2)
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Visceral fat (measured in grams)
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Blood glucose levels (serum, fasted state)
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Cholesterol and total triglyceride levels (serum, fasted state)
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Resting blood pressure
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Systemic inflammation markers (levels of c-reactive protein, TNF-alpha, interleukin 6 and interleukin 8 in serum, fasted state)
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Arterial stiffness
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Health-related quality of life (measured using the SF-36 questionnaire; scores from 0-100, where a higher score means a better outcome)
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Body mass index
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Maximal muscle strength (measured in newtons produced during a leg press exercise)
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Maximal muscle power (measured in watts produced during a leg press exercise)
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Waist circumference
Difference in change between the two study arms from before to after the 12-week intervention/control period
Measured: From before to after the 12-week intervention/control period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study startAug 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Communicable Chronic DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inland Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450406
- Sponsor's protocol ID
- Trainome-031
- Acronym
- INHLCS
- Status last verified
- Aug 2022
- First submitted
- 28 Jun 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Inland Norway Healthy Life Center Study
- ClinicalTrials.gov ID
- NCT05450406
- Acronym / sponsor ID
- INHLCS / Trainome-031
- Conditions
- Non-Communicable Chronic Diseases, Obesity, Insulin Resistance, Musculoskeletal Diseases, Psychological Disorder, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Inland Norway University of Applied SciencesUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Jul 2022 (actual)
- 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.
Healthy Life Centers (Norwegian, 'Frisklivssentralen') is a municipal service in Norway that aims to promote both physical and mental health, as well as to limit the development of non-communicable diseases. Previous research has shown that receiving follow-up from Healthy Life Centers has led to higher levels of daily physical activity, in addition to improved self-reported health and quality of life among the participants. However, there is a lack of studies that have examined what kind of physiological health effects can be expected from participating in the Healthy Life Center's follow-up.
In this study, responses to the 12-week physical activity program of the Healthy Life Center will be compared with the responses in a negative control group that does not receive such follow-up. Both the intervention group and the reference group (the negative control group) will carry out the same tests and measurements before and after the 12 week period. The tests will include measurements of anthropometric variables (body height, body weight and waist circumference), body composition, arterial stiffness, resting blood pressure and blood variables (blood glucose, long-term blood glucose, blood lipid profile and inflammation markers), in addition to physical tests of mobility, balance, maximum aerobic capacity (maximal oxygen consumption) and maximum muscle strength. Questionnaires related to adherence to the Healthy Life Center follow-up, socio-demographic variables, eating and drinking habits, activity level, perceived physical fitness, motivation for exercise, and health-related quality of life will also be included.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Physical activityParticipants in the intervention group will receive 12-week follow-up from the Healthy Life Center |
| Control group | No intervention | –Participants in the intervention group will not receive follow-up from the Healthy Life Center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years of age
- Receiving follow-up from the Healthy Life Center
- >18 years of age
Key exclusion criteria (4 listed)
- In average >1 weekly exercise training session the last three months
- Reference group
- In average >1 weekly exercise training session the last three months
- Receiving follow-up from the Healthy Life Center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityThe participants will receive the possibility to attend weekly endurance, resistance and yoga exercise sessions administered by the Healthy Life Center. They will also receive personalized follow-up from the Healthy Life Center, and have the possibility to exercise at the local gym. | Other | Intervention group |
Primary outcome
Maximal oxygen consumption (measured in mL/kg body mass/min)
Time frame: From before to after the 12-week intervention/control period
Difference in change between the two study arms from before to after the 12-week intervention/control period
16 secondary outcomes
Balance, measured using the "single leg stance test" (measured in seconds)
Time frame: From before to after the 12-week intervention/control period
Mobility, measured using the "sit-and-reach" and the "back stretch" test (measured in centimeters)
Time frame: From before to after the 12-week intervention/control period
Fat mass (measured in kilograms)
Time frame: From before to after the 12-week intervention/control period
Lean mass (measured in kilograms)
Time frame: From before to after the 12-week intervention/control period
Bone mineral density ( measured in g/cm2)
Time frame: From before to after the 12-week intervention/control period
Visceral fat (measured in grams)
Time frame: From before to after the 12-week intervention/control period
Blood glucose levels (serum, fasted state)
Time frame: From before to after the 12-week intervention/control period
Cholesterol and total triglyceride levels (serum, fasted state)
Time frame: From before to after the 12-week intervention/control period
Resting blood pressure
Time frame: From before to after the 12-week intervention/control period
Systemic inflammation markers (levels of c-reactive protein, TNF-alpha, interleukin 6 and interleukin 8 in serum, fasted state)
Time frame: From before to after the 12-week intervention/control period
Arterial stiffness
Time frame: From before to after the 12-week intervention/control period
Health-related quality of life (measured using the SF-36 questionnaire; scores from 0-100, where a higher score means a better outcome)
Time frame: From before to after the 12-week intervention/control period
Body mass index
Time frame: From before to after the 12-week intervention/control period
Maximal muscle strength (measured in newtons produced during a leg press exercise)
Time frame: From before to after the 12-week intervention/control period
Maximal muscle power (measured in watts produced during a leg press exercise)
Time frame: From before to after the 12-week intervention/control period
Waist circumference
Time frame: From before to after the 12-week intervention/control period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Non-Communicable Chronic Diseases and Obesity, run by Inland Norway University of Applied Sciences.
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 3 inclusion and 4 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 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Knut Sindre Mølmen, PhD (+47 61 28 85 53, knut.sindre.molmen@inn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen consumption (measured in mL/kg body mass/min) (time frame: From before to after the 12-week intervention/control period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2022.