Clinical trial NCT05450406: The Inland Norway Healthy Life Center Study
Official title: The Inland Norway Healthy Life Center Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-Communicable Chronic Diseases
Obesity
Insulin Resistance
Musculoskeletal Diseases
Psychological Disorder
Cardiovascular Diseases
Lead sponsor: Inland Norway University of Applied Sciences
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Maximal oxygen consumption (measured in mL/kg body mass/min)
timeFrame: From before to after the 12-week intervention/control period
Secondary outcomes:
measure: Balance, measured using the "single leg stance test" (measured in seconds)
timeFrame: From before to after the 12-week intervention/control period
measure: Mobility, measured using the "sit-and-reach" and the "back stretch" test (measured in centimeters)
timeFrame: From before to after the 12-week intervention/control period
measure: Fat mass (measured in kilograms)
timeFrame: From before to after the 12-week intervention/control period
measure: Lean mass (measured in kilograms)
timeFrame: From before to after the 12-week intervention/control period
measure: Bone mineral density ( measured in g/cm2)
timeFrame: From before to after the 12-week intervention/control period
measure: Visceral fat (measured in grams)
timeFrame: From before to after the 12-week intervention/control period
measure: Blood glucose levels (serum, fasted state)
timeFrame: From before to after the 12-week intervention/control period
measure: Cholesterol and total triglyceride levels (serum, fasted state)
timeFrame: From before to after the 12-week intervention/control period
measure: Resting blood pressure
timeFrame: From before to after the 12-week intervention/control period
measure: Systemic inflammation markers (levels of c-reactive protein, TNF-alpha, interleukin 6 and interleukin 8 in serum, fasted state)
timeFrame: From before to after the 12-week intervention/control period
measure: Arterial stiffness
timeFrame: From before to after the 12-week intervention/control period
measure: Health-related quality of life (measured using the SF-36 questionnaire; scores from 0-100, where a higher score means a better outcome)
timeFrame: From before to after the 12-week intervention/control period
measure: Body mass index
timeFrame: From before to after the 12-week intervention/control period
measure: Maximal muscle strength (measured in newtons produced during a leg press exercise)
timeFrame: From before to after the 12-week intervention/control period
measure: Maximal muscle power (measured in watts produced during a leg press exercise)
timeFrame: From before to after the 12-week intervention/control period
measure: Waist circumference
timeFrame: From before to after the 12-week intervention/control period
Other outcomes:
measure: Activity level
timeFrame: From before to after the 12-week intervention/control period
measure: Adherence to the 12-week intervention (measured as the number of sessions the participant attended divided by the number of sessions prescribed)
timeFrame: During the 12-week intervention
measure: 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)
timeFrame: During the 12-week intervention
Locations:
Study officials:
References: