The Inland Norway Healthy Life Center Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- Maximal oxygen consumption (measured in mL/kg body mass/min)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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
Arms & Interventions
Intervention group
Participants in the intervention group will receive 12-week follow-up from the Healthy Life Center
Intervention: Physical activity (Other)
Control group
Participants in the intervention group will not receive follow-up from the Healthy Life Center
Outcomes
Primary Outcomes
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
- Maximal muscle strength (measured in newtons produced during a leg press exercise)(From before to after the 12-week intervention/control period)
- Maximal muscle power (measured in watts produced during a leg press exercise)(From before to after the 12-week intervention/control period)
- Waist circumference(From before to after the 12-week intervention/control period)
- Balance, measured using the "single leg stance test" (measured in seconds)(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)(From before to after the 12-week intervention/control period)
- Fat mass (measured in kilograms)(From before to after the 12-week intervention/control period)
- Lean mass (measured in kilograms)(From before to after the 12-week intervention/control period)
- Visceral fat (measured in grams)(From before to after the 12-week intervention/control period)
- Cholesterol and total triglyceride levels (serum, fasted state)(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)(From before to after the 12-week intervention/control period)
- Body mass index(From before to after the 12-week intervention/control period)
- Bone mineral density ( measured in g/cm2)(From before to after the 12-week intervention/control period)
- Blood glucose levels (serum, fasted state)(From before to after the 12-week intervention/control period)
- Resting blood pressure(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)(From before to after the 12-week intervention/control period)
- Arterial stiffness(From before to after the 12-week intervention/control period)