INHLCS: The Inland Norway Healthy Life Center Study

Sponsor
Inland Norway University of Applied Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05450406
Collaborator
(none)
60
2
47

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physical activity
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Inland Norway Healthy Life Center Study
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intervention group

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

Other: Physical activity
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.

No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

  1. Maximal oxygen consumption (measured in mL/kg body mass/min) [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 Outcome Measures

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

  1. Activity level [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) [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) [During the 12-week intervention]

    For the intervention group

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Inland Norway University of Applied Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Inland Norway University of Applied Sciences
ClinicalTrials.gov Identifier:
NCT05450406
Other Study ID Numbers:
  • Trainome-031
First Posted:
Jul 8, 2022
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2022