The Inland Norway Healthy Life Center Study (INHLCS)

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 Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Obesity; Musculoskeletal Diseases; Insulin Resistance; Psychological Disorder; Non-Communicable Chronic Diseases
• Intervention / Treatment: Other: Physical activity

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Knut Sindre Mølmen, PhD; Phone Number: +47 61 28 85 53; Email: knut.sindre.molmen@inn.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Inland Norway University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): July 1, 2026

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Hyperinsulinism; Cardiovascular Diseases; Mental Disorders; Insulin Resistance; Chronic Disease; Musculoskeletal Diseases; Noncommunicable Diseases
• Other Study ID Numbers: Trainome-031

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No