NCT06749249

Brief Summary

A sufficient level of physical activity (PA) positively affects health and longevity. In Swedish healthcare, insufficiently physically active patients are offered physical activity on prescription (PAP) treatment, an individual support to increase physical activity level. This study investigates the influence of possible mediators and factors associated with a PA level change in primary care patients during a 5-year PAP intervention. The study population includes 444 patients (56% females), aged 27 to 85 years, with metabolic risk factors and being physically inactive. The patients receive individualized PAP-treatment including PA-consultations, agreed PA recommendations with a written prescription, and structured follow-ups. Associations between 10 theoretical important mediators and factors of PA change, measured at 6 occasions, are analysed against PA level at 5 years and PA level change during the 5-year intervention.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2019

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
Last Updated

January 6, 2025

Status Verified

December 1, 2024

Enrollment Period

4.6 years

First QC Date

December 19, 2024

Last Update Submit

January 3, 2025

Conditions

Keywords

Physical activity on prescriptionMediators of physical activity change

Outcome Measures

Primary Outcomes (1)

  • Change in self-reported PA-level according to the public health recommendation.

    Self-assessment of PA-level according to American college of sports medicine (ACSM) and American heart association (AHA) public health recommendation 2007. The patient responds to two PA questions, where 30 minutes of moderate-intensity PA per day results in 1 point and 20 minutes of more vigorous-intensity PA per day results in 1.7 point during each specific day of the week. A value of \<5 points indicates an inadequate PA level corresponding to \<150 min/week at a moderate intensity level alternatively 75 min/week at a high intensity level.

    From enrollment to the end of treatment at 5 years.

Secondary Outcomes (7)

  • Outcome expectations - Outcome Expectations for Exercise-2 Scale (OEE-2)

    From enrollment to the end of treatment at 5 years

  • Enjoyment - Physical Activity Enjoyment Scale (PACES)

    From enrollment to the end of treatment at 5 years.

  • Confidence in readiness to change

    From enrollment to the end of treatment at 5 years.

  • Self-efficacy expectations - Self-Efficacy for Exercise Scale (SEE)

    From enrollment to the end of treatment at 5 years.

  • Social support - Social support for exercise scale (SSES)

    From enrollment to the end of treatment at 5 years.

  • +2 more secondary outcomes

Other Outcomes (1)

  • Socio demographic data.

    From enrollment to the end of treatment at 5 years.

Eligibility Criteria

Age27 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population included 444 patients, aged 27-85 years, with metabolic risk factors and being insufficiently physically active according to the internationally recommended minimum PA level of 150 min/week. The patients were recruited between 2010 and 2014 from 15 primary health care centres in Gothenburg, Sweden, as a convenience sample after agreeing to participate in the PAP treatment.

You may qualify if:

  • Physically inactive according to ACSM/AHA public health recommendation from 2007.
  • Having at least one component of the metS present according to the National Cholesterol Education Program (NCEP) classification.
  • Receiving PAP-treatment. Understanding the Swedish language.

You may not qualify if:

  • The patient decline to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (22)

  • Buffey AJ, Herring MP, Langley CK, Donnelly AE, Carson BP. The Acute Effects of Interrupting Prolonged Sitting Time in Adults with Standing and Light-Intensity Walking on Biomarkers of Cardiometabolic Health in Adults: A Systematic Review and Meta-analysis. Sports Med. 2022 Aug;52(8):1765-1787. doi: 10.1007/s40279-022-01649-4. Epub 2022 Feb 11.

    PMID: 35147898BACKGROUND
  • Onerup A, Arvidsson D, Blomqvist A, Daxberg EL, Jivegard L, Jonsdottir IH, Lundqvist S, Mellen A, Persson J, Sjogren P, Svanberg T, Borjesson M. Physical activity on prescription in accordance with the Swedish model increases physical activity: a systematic review. Br J Sports Med. 2019 Mar;53(6):383-388. doi: 10.1136/bjsports-2018-099598. Epub 2018 Nov 9.

    PMID: 30413421BACKGROUND
  • Lundqvist S, Borjesson M, Larsson MEH, Cider A, Hagberg L. Which patients benefit from physical activity on prescription (PAP)? A prospective observational analysis of factors that predict increased physical activity. BMC Public Health. 2019 May 2;19(1):482. doi: 10.1186/s12889-019-6830-1.

    PMID: 31046720BACKGROUND
  • Lindsay Smith G, Banting L, Eime R, O'Sullivan G, van Uffelen JGZ. The association between social support and physical activity in older adults: a systematic review. Int J Behav Nutr Phys Act. 2017 Apr 27;14(1):56. doi: 10.1186/s12966-017-0509-8.

    PMID: 28449673BACKGROUND
  • Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.

    PMID: 847061BACKGROUND
  • Klompstra L, Deka P, Almenar L, Pathak D, Munoz-Gomez E, Lopez-Vilella R, Marques-Sule E. Physical activity enjoyment, exercise motivation, and physical activity in patients with heart failure: A mediation analysis. Clin Rehabil. 2022 Oct;36(10):1324-1331. doi: 10.1177/02692155221103696. Epub 2022 Jun 9.

    PMID: 35678610BACKGROUND
  • Chen Y, Jin X, Chen G, Wang R, Tian H. Dose-Response Relationship Between Physical Activity and the Morbidity and Mortality of Cardiovascular Disease Among Individuals With Diabetes: Meta-Analysis of Prospective Cohort Studies. JMIR Public Health Surveill. 2024 Aug 19;10:e54318. doi: 10.2196/54318.

    PMID: 38780218BACKGROUND
  • Teixeira PJ, Carraca EV, Markland D, Silva MN, Ryan RM. Exercise, physical activity, and self-determination theory: a systematic review. Int J Behav Nutr Phys Act. 2012 Jun 22;9:78. doi: 10.1186/1479-5868-9-78.

    PMID: 22726453BACKGROUND
  • Eynon M, Foad J, Downey J, Bowmer Y, Mills H. Assessing the psychosocial factors associated with adherence to exercise referral schemes: A systematic review. Scand J Med Sci Sports. 2019 May;29(5):638-650. doi: 10.1111/sms.13403. Epub 2019 Mar 7.

    PMID: 30742334BACKGROUND
  • Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.

    PMID: 3432232BACKGROUND
  • Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000 May-Jun;49(3):154-9. doi: 10.1097/00006199-200005000-00007.

    PMID: 10882320BACKGROUND
  • Kendzierski D, DeCarlo KJ. Physical activity enjoyment scale: two validation studies. Journal of Sport & Exercise Psychology. 1991;13(1)

    BACKGROUND
  • Barnett I, Guell C, Ogilvie D. The experience of physical activity and the transition to retirement: a systematic review and integrative synthesis of qualitative and quantitative evidence. Int J Behav Nutr Phys Act. 2012 Aug 16;9:97. doi: 10.1186/1479-5868-9-97.

    PMID: 22897911BACKGROUND
  • Prochaska JO. Decision making in the transtheoretical model of behavior change. Med Decis Making. 2008 Nov-Dec;28(6):845-9. doi: 10.1177/0272989X08327068. Epub 2008 Nov 17.

    PMID: 19015286BACKGROUND
  • Resnick B. Reliability and validity of the Outcome Expectations for Exercise Scale-2. J Aging Phys Act. 2005 Oct;13(4):382-94. doi: 10.1123/japa.13.4.382.

    PMID: 16301750BACKGROUND
  • Hagberg LA, Lindahl B, Nyberg L, Hellenius ML. Importance of enjoyment when promoting physical exercise. Scand J Med Sci Sports. 2009 Oct;19(5):740-7. doi: 10.1111/j.1600-0838.2008.00844.x. Epub 2008 Aug 5.

    PMID: 18694433BACKGROUND
  • Baranowski T, Anderson C, Carmack C. Mediating variable framework in physical activity interventions. How are we doing? How might we do better? Am J Prev Med. 1998 Nov;15(4):266-97. doi: 10.1016/s0749-3797(98)00080-4.

    PMID: 9838973BACKGROUND
  • Rhodes RE, Boudreau P, Josefsson KW, Ivarsson A. Mediators of physical activity behaviour change interventions among adults: a systematic review and meta-analysis. Health Psychol Rev. 2021 Jun;15(2):272-286. doi: 10.1080/17437199.2019.1706614. Epub 2020 Jan 8.

    PMID: 31875768BACKGROUND
  • Kahlert D. Maintenance of physical activity: Do we know what we are talking about? Prev Med Rep. 2015 Mar 1;2:178-80. doi: 10.1016/j.pmedr.2015.02.013. eCollection 2015.

    PMID: 26844069BACKGROUND
  • Lundqvist S, Cider A, Larsson MEH, Hagberg L, Bjork MP, Borjesson M. The effects of a 5-year physical activity on prescription (PAP) intervention in patients with metabolic risk factors. PLoS One. 2022 Oct 31;17(10):e0276868. doi: 10.1371/journal.pone.0276868. eCollection 2022.

    PMID: 36315564BACKGROUND
  • Bourke E, Rawstorn J, Maddison R, Blakely T. The effects of physical inactivity on other risk factors for chronic disease: A systematic review of reviews. Prev Med Rep. 2024 Aug 22;46:102866. doi: 10.1016/j.pmedr.2024.102866. eCollection 2024 Oct.

    PMID: 39257876BACKGROUND
  • Joseph MS, Tincopa MA, Walden P, Jackson E, Conte ML, Rubenfire M. The Impact Of Structured Exercise Programs On Metabolic Syndrome And Its Components: A Systematic Review. Diabetes Metab Syndr Obes. 2019 Nov 18;12:2395-2404. doi: 10.2147/DMSO.S211776. eCollection 2019.

    PMID: 31819565BACKGROUND

MeSH Terms

Conditions

Health BehaviorMotor ActivityMetabolic Syndrome

Condition Hierarchy (Ancestors)

BehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2024

First Posted

December 27, 2024

Study Start

January 1, 2010

Primary Completion

August 1, 2014

Study Completion

May 2, 2019

Last Updated

January 6, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Unidentifiable patient data for all primary and secondary outcome measures will be made available in a source data file (XLSX) in published article.

Time Frame
A source data file will be available in section "Supporting information" in published article.