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The Inland Norway Healthy Life Center Study (INHLCS)

Primary Purpose

Non-Communicable Chronic Diseases, Obesity, Insulin Resistance

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical activity
Sponsored by
Inland Norway University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-Communicable Chronic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    Participants in the intervention group will receive 12-week follow-up from the Healthy Life Center

    Participants in the intervention group will not receive follow-up from the Healthy Life Center

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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
    Fat mass (measured in kilograms)
    Difference in change between the two study arms 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
    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
    Visceral fat (measured in grams)
    Difference in change between the two study arms 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
    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
    Resting blood pressure
    Difference in change between the two study arms 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
    Arterial stiffness
    Difference in change between the two study arms 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
    Body mass index
    Difference in change between the two study arms 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
    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
    Waist circumference
    Difference in change between the two study arms from before to after the 12-week intervention/control period

    Full Information

    First Posted
    June 28, 2022
    Last Updated
    August 30, 2022
    Sponsor
    Inland Norway University of Applied Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05450406
    Brief Title
    The Inland Norway Healthy Life Center Study
    Acronym
    INHLCS
    Official Title
    The Inland Norway Healthy Life Center Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2022 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    July 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Inland Norway University of Applied Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Communicable Chronic Diseases, Obesity, Insulin Resistance, Musculoskeletal Diseases, Psychological Disorder, Cardiovascular Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Active Comparator
    Arm Description
    Participants in the intervention group will receive 12-week follow-up from the Healthy Life Center
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Participants in the intervention group will not receive follow-up from the Healthy Life Center
    Intervention Type
    Other
    Intervention Name(s)
    Physical activity
    Intervention Description
    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 Outcome Measure Information:
    Title
    Maximal oxygen consumption (measured in mL/kg body mass/min)
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Secondary Outcome Measure Information:
    Title
    Balance, measured using the "single leg stance test" (measured in seconds)
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Mobility, measured using the "sit-and-reach" and the "back stretch" test (measured in centimeters)
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Fat mass (measured in kilograms)
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Lean mass (measured in kilograms)
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Bone mineral density ( measured in g/cm2)
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Visceral fat (measured in grams)
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Blood glucose levels (serum, fasted state)
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Cholesterol and total triglyceride levels (serum, fasted state)
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Resting blood pressure
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Systemic inflammation markers (levels of c-reactive protein, TNF-alpha, interleukin 6 and interleukin 8 in serum, fasted state)
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Arterial stiffness
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Health-related quality of life (measured using the SF-36 questionnaire; scores from 0-100, where a higher score means a better outcome)
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Body mass index
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Maximal muscle strength (measured in newtons produced during a leg press exercise)
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Maximal muscle power (measured in watts produced during a leg press exercise)
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Waist circumference
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Other Pre-specified Outcome Measures:
    Title
    Activity level
    Description
    Difference in change between the two study arms from before to after the 12-week intervention/control period
    Time Frame
    From before to after the 12-week intervention/control period
    Title
    Adherence to the 12-week intervention (measured as the number of sessions the participant attended divided by the number of sessions prescribed)
    Description
    For the intervention group
    Time Frame
    During the 12-week intervention
    Title
    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)
    Description
    For the intervention group
    Time Frame
    During the 12-week intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Knut Sindre Mølmen, PhD
    Phone
    +47 61 28 85 53
    Email
    knut.sindre.molmen@inn.no

    12. IPD Sharing Statement

    Learn more about this trial

    The Inland Norway Healthy Life Center Study

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