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NCT Number: NCT05450406

The Inland Norway Healthy Life Center 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.

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Key information

Conditions

Non-Communicable Chronic Diseases Body Weight Cardiovascular Diseases Disease Attributes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Musculoskeletal Diseases Noncommunicable Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Psychological Disorder Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Intervention group

Inclusion criteria

  • >18 years of age
  • Receiving follow-up from the Healthy Life Center

Exclusion criteria

  • In average >1 weekly exercise training session the last three months

Reference group

Inclusion criteria

  • >18 years of age

Exclusion criteria

  • In average >1 weekly exercise training session the last three months
  • Receiving follow-up from the Healthy Life Center

Treatment and study plan

Physical activity

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Balance, measured using the "single leg stance test" (measured in seconds)

    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

  2. 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

    Difference in change between the two study arms from before to after the 12-week intervention/control period

  3. Fat mass (measured in kilograms)

    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

  4. Lean mass (measured in kilograms)

    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

  5. Bone mineral density ( measured in g/cm2)

    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

  6. Visceral fat (measured in grams)

    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

  7. Blood glucose levels (serum, fasted state)

    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

  8. Cholesterol and total triglyceride levels (serum, fasted state)

    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

  9. Resting blood pressure

    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

  10. 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

    Difference in change between the two study arms from before to after the 12-week intervention/control period

  11. Arterial stiffness

    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

  12. 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

    Difference in change between the two study arms from before to after the 12-week intervention/control period

  13. Body mass index

    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

  14. Maximal muscle strength (measured in newtons produced during a leg press exercise)

    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

  15. Maximal muscle power (measured in watts produced during a leg press exercise)

    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. Waist circumference

    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

Other outcomes

  1. Activity level

    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

  2. Adherence to the 12-week intervention (measured as the number of sessions the participant attended divided by the number of sessions prescribed)

    Time frame: During the 12-week intervention

    For the intervention group

  3. Compliance to the 12-week intervention (measured as the number of sessions the participant conducted the session as prescribed divided by the number of total sessions)

    Time frame: During the 12-week intervention

    For the intervention group

Study contacts

Contact information is provided by the study sponsor or research team.

Knut Sindre Mølmen, PhD

CONTACT

[email protected]

+47 61 28 85 53

Sponsors and collaborators

Lead sponsor

Inland Norway University of Applied Sciences

Other

Registry information

Acronym: INHLCS

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Jul 8, 2022
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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