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
About this trial
This is an interventional prevention trial for Non-Communicable Chronic Diseases
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
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
NCT ID
NCT05450406
First Posted
June 28, 2022
Last Updated
August 30, 2022
Sponsor
Inland Norway University of Applied Sciences
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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