The Inland Norway Healthy Life Center Study

Obesity Clinical Trial

— INHLCS  

Official title:

The Inland Norway Healthy Life Center Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05450406
• Other study ID #: Trainome-031
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2022
• Est. completion date: July 2026

Study information

• Verified date: August 2022
• Source: Inland Norway University of Applied Sciences
• Contact: Knut Sindre Mølmen, PhD
• Phone: +47 61 28 85 53
• Email: knut.sindre.molmen[@]inn.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Disease
• Insulin Resistance
• Mental Disorders
• Musculoskeletal Diseases
• Non-Communicable Chronic Diseases
• Noncommunicable Diseases
• Obesity
• Psychological Disorder

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inland Norway University of Applied Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Activity level	Difference in change between the two study arms from before to after the 12-week intervention/control period	From before to after the 12-week intervention/control period
Other	Adherence to the 12-week intervention (measured as the number of sessions the participant attended divided by the number of sessions prescribed)	For the intervention group	During the 12-week intervention
Other	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)	For the intervention group	During the 12-week intervention
Primary	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	From before to after the 12-week intervention/control period
Secondary	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	From before to after the 12-week intervention/control period
Secondary	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	From before to after the 12-week intervention/control period
Secondary	Fat mass (measured in kilograms)	Difference in change between the two study arms from before to after the 12-week intervention/control period	From before to after the 12-week intervention/control period
Secondary	Lean mass (measured in kilograms)	Difference in change between the two study arms from before to after the 12-week intervention/control period	From before to after the 12-week intervention/control period
Secondary	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	From before to after the 12-week intervention/control period
Secondary	Visceral fat (measured in grams)	Difference in change between the two study arms from before to after the 12-week intervention/control period	From before to after the 12-week intervention/control period
Secondary	Blood glucose levels (serum, fasted state)	Difference in change between the two study arms from before to after the 12-week intervention/control period	From before to after the 12-week intervention/control period
Secondary	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	From before to after the 12-week intervention/control period
Secondary	Resting blood pressure	Difference in change between the two study arms from before to after the 12-week intervention/control period	From before to after the 12-week intervention/control period
Secondary	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	From before to after the 12-week intervention/control period
Secondary	Arterial stiffness	Difference in change between the two study arms from before to after the 12-week intervention/control period	From before to after the 12-week intervention/control period
Secondary	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	From before to after the 12-week intervention/control period
Secondary	Body mass index	Difference in change between the two study arms from before to after the 12-week intervention/control period	From before to after the 12-week intervention/control period
Secondary	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	From before to after the 12-week intervention/control period
Secondary	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	From before to after the 12-week intervention/control period
Secondary	Waist circumference	Difference in change between the two study arms from before to after the 12-week intervention/control period	From before to after the 12-week intervention/control period