The Inland Norway Healthy Life Center Study

NCT05450406 | Not Yet Recruiting DMC

• 1 other identifier: Trainome-031
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Communicable Chronic Diseases; Obesity; Insulin Resistance; Musculoskeletal Diseases; Psychological Disorder; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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

• Bone mineral density ( measured in g/cm2)

  From before to after the 12-week intervention/control period

Other Outcomes (3)

• Activity level

  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)

  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)

  During the 12-week intervention

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Participants in the intervention group will receive 12-week follow-up from the Healthy Life Center

Other: Physical activity

Control group

NO INTERVENTION

Participants in the intervention group will not receive follow-up from the Healthy Life Center

Interventions

Physical activity OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Receiving follow-up from the Healthy Life Center

You may not qualify if:

• In average \>1 weekly exercise training session the last three months
• Reference group
• \>18 years of age
• In average \>1 weekly exercise training session the last three months
• Receiving follow-up from the Healthy Life Center

Sponsors & Collaborators

• Inland Norway University of Applied Sciences: lead

MeSH Terms

Conditions

Noncommunicable Diseases; Obesity; Insulin Resistance; Musculoskeletal Diseases; Mental Disorders; Cardiovascular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Knut Sindre Mølmen, PhD

CONTACT

+47 61 28 85 53; knut.sindre.molmen@inn.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 8, 2022
• Study Start: August 1, 2022
• Primary Completion: December 1, 2023
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 31, 2022

Record last verified: 2022-08