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Health BehaviorNCT06749249

Enjoyment Mediates Long-term Changes in Physical Activity Level in a Physical Activity on Prescription Intervention.

An observational study of Health Behavior and Physical Activity, run by Vastra Gotaland Region.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 27 to 85 years
How many people
444 participants
Where
No sites listed yet
Study dates
1 Jan 2010to 2 May 2019
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 27 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • The patient decline to participate.

About this study

Official title: Enjoyment Mediates Long-term Changes in Physical Activity Level in a Physical Activity on Prescription Intervention

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.

Read the detailed description

Aim:

To investigate the influence of possible mediators and factors associated with a physical activity (PA) level change in primary care patients during a 5-year physical activity on prescription (PAP) intervention.

Study design:

This is a longitudinal prospective observational cohort study with a 5-year follow-up of PAP-treatment. The treatment is carried out as part of a daily clinical primary care practice.

Study population:

The 444 patients (56% females), aged 27 to 85 years, are selected from 15 primary health care centres in Gothenburg, being physically inactive, having at least one component of the metabolic syndrome present and receiving PAP-treatment. The patients have to understand the Swedish language to fill in the questionnaires.

Intervention:

The PAP-treatment is offered by authorized personnel, educated in PA-effects and PAP-intervention and consists of an individual-based dialogue with the patient, an individually tailored recommendation of PA including a written prescription, and customized, structured support during 5 years. The patients health status, previous respectively current PA level, preferences for different physical activities, motivation, self-efficacy and readiness to change PA behavior are evaluated. An agreed individually dosed PA is written down and the support during the 5-year intervention is individually structured either by revisits or by telephone contacts.

Measurements:

The following measurements are conducted on 6 occasions during the 5-year intervention, at baseline and at the 6-month-, 1.5-, 2.5-, 3.5-, and 5-year follow-ups: PA-level, outcome expectations, enjoyment, confidence in readiness to change, self-efficacy, social support, health related quality of life, body mass index (BMI), age and sex.

Statistical analysis:

Differences between baseline and the 5-year follow-up, within the group, are analyzed using the paired sample t-test or Wilcoxon sign-rank test, based on the data level. A change score (PA at 5 year - PA at baseline) of PA is conducted, thereafter associations between theoretical important mediators of PA change (i.e., outcome expectation and confidence at baseline, and enjoyment, self-efficacy, family positive support, friends positive support and family negative support at 5 year) and PA level at 5 years and PA level change are analyzed using a linear regression. In a final step a mediation model of the mediators of PA change: enjoyment, self-efficacy, and social support and PA level at 5 years and PA level change is conducted using the lavaan package in RStudio version 1.4.1106.

Keywords
Physical activity on prescription, Mediators of physical activity change
Medical subject headings
Health Behavior, Motor Activity, Metabolic Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of treatment at 5 years.

Secondary outcomes (7)

  1. Outcome expectations - Outcome Expectations for Exercise-2 Scale (OEE-2)

    Including 13 positively- (e.g. "Helps me feel less tired"), or negatively- (e.g. "Is something I avoid because it causes me to be short of breath") worded items rated on a 5-point Likert scale (1: Strongly agree, 5: Strongly disagree). After a reverse-scoring of the positive OEE items, the numerical values for each response were summarised and divided by the number of items where a highly valued outcome expectation from the patient gave a high total score.

    Measured: From enrollment to the end of treatment at 5 years

  2. Enjoyment - Physical Activity Enjoyment Scale (PACES)

    Including 16 positively- (e.g." I think it´s fun", "It gives me energy"), or negatively- (e.g. "I feel bored", "I don´t like it") worded items rated on a 5-point Likert scale (1: Does not apply at all, 5: Truly applies). The negative PACES items were reversed-scored, and the responses were added to a score ranging from 16 to 80 where higher scores indicated higher estimated enjoyment.

    Measured: From enrollment to the end of treatment at 5 years.

  3. Confidence in readiness to change

    Was assessed with the question "How confident are you about succeeding with changing PA level?" (36, 54) via a 100-mm visual analogue scale (VAS) anchored at each end with words that describe the minimum (Not at all) and maximum (Very) extremes.

    Measured: From enrollment to the end of treatment at 5 years.

  4. Self-efficacy expectations - Self-Efficacy for Exercise Scale (SEE)

    The patient´s self-efficacy in being able to exercise 3 times a week for 20 min despite obstacles was measured with a questionnaire including 9 items (e.g. "The weather was bothering you", "You had to exercise alone") rated on an ordinal 10-point scale (1: Not confident, 10: Very confident) where the item scores were summarised and divided by the numbers of responses.

    Measured: From enrollment to the end of treatment at 5 years.

  5. Social support - Social support for exercise scale (SSES)

    Including 13 items - 11 positively-worded (participation and involvement) and 2 negatively-worded (rewards and punishments) rated on a 5-point Likert scale (1: None, 5: Very often). The item scores were summarised in three subgroups: Family support - positive, Friend support - positive, and Family support - negative.

    Measured: From enrollment to the end of treatment at 5 years.

  6. Health related quality of life - the Swedish version of the Short Form 36 (SF-36 Standard Swedish Version 1.0)

    Includes 36 questions generating 8 health concepts that were grouped into a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS are converted to 0 to 100 points, with higher values representing better HRQoL.

    Measured: From enrollment to the end of treatment at 5 years.

  7. Body mass index - BMI

    Measured body weight in kilograms (kg), with light clothing and without shoes to the nearest 0.1 kg using an electric scale (Carl Lidén AFW D300, Jönköping, Sweden) and measured body height in meters (m), measured in an upright position without shoes to the nearest 0.5 cm using a scale fixed to the wall (PEM 136, Hultafors, Sweden). Weight and height will be combined and calculated to report BMI in kg/m2.

    Measured: From enrollment to the end of treatment at 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2024
  2. Study start1 Jan 2010
  3. Primary completion1 Aug 2014
  4. Study completion2 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
444 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06749249
Sponsor's protocol ID
Mediator study 282895
Status last verified
Dec 2024
First submitted
19 Dec 2024
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Unidentifiable patient data for all primary and secondary outcome measures will be made available in a source data file (XLSX) in published article.

Publications

  • 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.

    PubMed 35147898

  • 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.

    PubMed 30413421

  • 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.

    PubMed 31046720

  • 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.

    PubMed 28449673

  • 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.

    PubMed 847061

  • 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.

    PubMed 35678610

  • 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.

    PubMed 38780218

  • 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.

    PubMed 22726453

  • 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.

    PubMed 30742334

  • 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.

    PubMed 3432232

  • 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.

    PubMed 10882320

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

  • 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.

    PubMed 22897911

  • 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.

    PubMed 19015286

  • 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.

    PubMed 16301750

Questions about this trial

What is this clinical trial studying?

An observational study of Health Behavior and Physical Activity, run by Vastra Gotaland Region.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in self-reported PA-level according to the public health recommendation. (time frame: From enrollment to the end of treatment at 5 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06749249, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.

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