Increased Physical Activity Through Mindfulness

NCT ID: NCT02869854

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-12-18

Brief Summary

In a pilot study, 90 physically inactive patients will be opportunistically and consecutively recruited and randomized to three intervention groups: mindfulness training, Physical Activity on Prescription (PAP) or only PAP. Follow-up will be done at baseline, three and six months with questionnaires, accelerometers and analysis of traditional risk factors to evaluate whether mindfulness may increase physical activity and decrease physical inactivity.

Detailed Description

All patients between 40 and 65 years of age who fulfil the inclusion criteria will be asked to participate in the study. Posters with information about the study will be put in the waiting room and in other strategic places. Patients who accept to participate will get written and oral information; they will sign an informed consent after the information. The patients will estimate their level of physical activity in minutes per week to control inclusion criteria. The patients will return in the morning for fasting blood samples and get an accelerometer attached to them to wear for 7 days. During this time, randomization will be performed. They will also get to answer a couple of different surveys. The results from the surveys and blood samples will be the study baseline.

All patients with abnormal test results will follow a specific flow diagram for the usual care.

Conditions

Physical Activity; Life Style; Mindfulness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

PAP only

This group will follow the referral scheme for three months, and after this period they will leave new blood samples and answer surveys. They will get a new PAP with follow up after another 3 months.

Group Type: ACTIVE_COMPARATOR

PAP

Intervention Type: BEHAVIORAL

Physical Activity on Prescription, after 3 months a new prescription

Mindfulness only

Mindfulness. This group will receive a group course in mindfulness during 8 weeks once a week, and with 20 minutes of daily personal training. Three and six months after inclusion they will answer a new set of surveys and fasting blood samples.

Group Type: ACTIVE_COMPARATOR

Mindfulness

Intervention Type: BEHAVIORAL

Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day

Combination of the two groups

Mindfulness and physical activity prescription. This group will get a combination of the two other groups. PAP will be prescribed during the first meeting and another one after 3 months. During the first 8 weeks once a week they will participate in a mindfulness training group and also preform 20 minutes of daily training. The same surveys as the other groups and fasting blood samples

Group Type: EXPERIMENTAL

Mindfulness

Intervention Type: BEHAVIORAL

Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day

PAP

Intervention Type: BEHAVIORAL

Physical Activity on Prescription, after 3 months a new prescription

Interventions

Mindfulness

Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day

Intervention Type: BEHAVIORAL

PAP

Physical Activity on Prescription, after 3 months a new prescription

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Individuals between 40-65 years of age, with insufficient physical activity ( <150 minutes of moderate-intensity physical activity throughout the week, or < 75 minutes of vigorous-intensity physical activity throughout the week, or an equivalent combination of moderate- and vigorous-intensity activity.)

Exclusion Criteria

• Dementia, severe mental disorder,newly diagnosed untreated unstable angina pectoris,myocardial infarction within 6 weeks prior to study entry. Individuals who do not master the Swedish language in speech and writing will be excluded.The patients who have abnormal values according to guidelines that require contact with a physician on the same day or week will also be excluded

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bengt Zöller, Docent

Role: PRINCIPAL_INVESTIGATOR

Lunds University

Locations

Lunds Unniversitet

Malmo, Skåne County, Sweden

Countries

Sweden

References

Nymberg P, Ekvall Hansson E, Stenman E, Calling S, Sundquist K, Sundquist J, Zoller B. Pilot study on increased adherence to physical activity on prescription (PAP) through mindfulness: study protocol. Trials. 2018 Oct 17;19(1):563. doi: 10.1186/s13063-018-2932-9.

Reference Type: BACKGROUND

PMID: 30333052 (View on PubMed)

Nymberg P, Calling S, Stenman E, Palmer K, Hansson EE, Sundquist K, Sundquist J, Zoller B. Effect of mindfulness on physical activity in primary healthcare patients: a randomised controlled trial pilot study. Pilot Feasibility Stud. 2021 Mar 17;7(1):70. doi: 10.1186/s40814-021-00810-6.

Reference Type: DERIVED

PMID: 33731219 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pny1

Identifier Type: -

Identifier Source: org_study_id