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BehaviorNCT01796990

Developing a Physically More Active Lifestyle Based on One's Own Values - RCT Among Sedentary Adults

A study testing ACT and REF in people with Behavior, run by Likes - Foundation for Sport and Health Sciences at 1 site in Finland.

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

The main objective of the study is to provide data of the effectiveness and feasibility of the Acceptance and Commitment Therapy in enhancing the physically active lifestyle among sedentary adults. The psychological and motivational factors related to physical activity and behavior change will also be evaluated. Read more about this study

Who is it for?
Ages 30 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Behavior
What is being tested?
ACT and REF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteFinland
Study dates
Aug 2011to Dec 2013
Phase
Interventional
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 30 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • age 30-50 years, working status, and don´t meet the current physical activity recommendations.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • LIKES Foundation for Sport and Health Sciences

    Jyväskylä, 40720

Other trials in Finland

About this study

Official title: Developing a Physically More Active Lifestyle Based on One's Own Values - Randomized Controlled Trial Among Sedentary Adults

The main objective of the study is to provide data of the effectiveness and feasibility of the Acceptance and Commitment Therapy in enhancing the physically active lifestyle among sedentary adults. The psychological and motivational factors related to physical activity and behavior change will also be evaluated.

Read the detailed description

In more detailed the study aimed to investigate the effectiveness of the acceptance- and commitment-based behavioural intervention concerning physical activity level and self-efficacy, as well as regarding planning and the acceptance of psychological and physical discomfort related to physical activity after 3 and 6 months compared to providing only individual written feedback on their physical activity. A further aim was to explore stability and maintenance of changes in physical activity at the 6 months follow-up. It was hypothesised that acceptance- and commitment-based behavioural intervention is more effective than feedback only in improving physical activity and related beliefs and cognitions.

Conditions
Behavior
Being tested
ACT, REF
Keywords
physical activity, psychological well-being, acceptance and commitment therapy, adults
Medical subject headings
Behavior, Motor Activity, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACTBehavioural

    The intervention program consists of six group sessions, about 90 minutes per session during the 9 weeks period of time. The group size is about 8-10 members per one group. All the participants get also pedometers for monitoring their physical activity during the intervention.

    The program aims to enhance physically active lifestyle and well-being through important life values and build committed action based on the chosen important things. The importance is also placed to a mindful awareness and flexibility to everyday actions related to physical activity. The program don´t include psycho-educational elements or counseling of the health or the health benefits of physical activity.

  • REFBehavioural

    The participants will get written feedback about their physical activity level after the baseline, and after 3, 6, 9 and 15 months of baseline compared to the current physical activity recommendations. Feedback will be created to illustrate participants´ activity level during the measurement week combining also the information from the diary. Feedback will be posted home and don´t include face to face interaction. As an incentive for participation, participants will also have opportunity to attend a body composition analyze and get short interpretation (15 min) of their own results in the research center.

Study groups in NCT01796990
Study groupRoleWhat they receive
REF groupActive comparatorThe participants will get written feedback about their physical activity level after the baseline, and after 3, 6, 9 and 15 months of baseline compared to the current physical activity recommendations. Feedback will be created to illustrate participants´ activity level during the measurement week combining also the information from the diary. Feedback will be posted home and don´t include face to face interaction. As an incentive for participation, participants will also have opportunity to attend a body composition analyze and get short interpretation (15 min) of their own results in the research center.
Receives: Behavioral: REF
ACT groupOtherThe ACT group gets the same procedure as the REF group. In addition, they will participate the ACT based program. The intervention program consists of six group sessions, about 90 minutes per session during the 9 weeks period of time. All the participants get also pedometers for monitoring their physical activity during the intervention. The program aims to enhance physically active lifestyle and well-being through important life values and build committed action based on the chosen important things. The importance is also placed to a mindful awareness and flexibility to everyday actions related to physical activity. The program don´t include psycho-educational elements or counseling of the health or the health benefits of physical activity.
Receives: Behavioral: ACT; Behavioral: REF

What is being measured

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

  1. Physical activity

    Physical activity is measured objectively by accelerometer (Actigraph GT1M, GT3X, Actigraph, Pensacola, Florida) the last seven days.

    Measured: baseline and change after 3, 6, 9 and 15 months

Secondary outcomes (4)

  1. The Acceptance and Action Questionnaire, AAQ-2

    Psychological wellbeing is measured using the Acceptance and Action Questionnaire (AAQ-2), which is a 10-item Likert-type questionnaire that assesses people's ability to take a non-elaborative, non-judgmental approach to their internal events, so that they can focus on the present moment and act in a way that is congruent with their values and goals, rather than with their internal events (e.g., fears, urges, prejudices).

    Measured: baseline and change after 3, 6, 9 and 15 months

  2. the Kentucky Inventory of Mindfulness Skills (KIMS)

    The KIMS is a 39-item self-report inventory used to assess mindfulness skills. The questionnaire contains four different specific subscales or skills: 1) observing, 2) describing, 3) acting with awareness, and 4) accepting without judgment. Participants rated each item on a 5-point Likert type scale ranging from 1 (never or very rarely true) to 5 (almost always or always true). Items reflects either direct descriptions of the mindfulness skills or the absence of that skill, and are reverse scored.

    Measured: baseline and change after 3, 6, 9 and 15 months

  3. the Beck Depression Inventory, BDI-II

    Depressive symptoms are measured with the Beck Depression Inventory, BDI-II.

    Measured: baseline and change after 3, 6, 9 and 15 months

  4. Physical activity

    Physical activity is assessed with a questionnaire (self-reported) during the last seven days.

    Measured: baseline and change after 3, 6, 9 and 15 months

Timeline

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

  1. First posted22 Feb 2013 (estimated)
  2. Study startAug 2011
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01796990
Sponsor's protocol ID
Likes-01
Other IDs
LIKES-01
Status last verified
Apr 2015
First submitted
13 Feb 2013
Last updated
29 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Kangasniemi AM, Lappalainen R, Kankaanpaa A, Tolvanen A, Tammelin T. Towards a physically more active lifestyle based on one's own values: the results of a randomized controlled trial among physically inactive adults. BMC Public Health. 2015 Mar 18;15:260. doi: 10.1186/s12889-015-1604-x.

    PubMed 25848812

  • Kangasniemi AM, Lappalainen R, Kankaanpaa A, Kulmala J, Hakonen H, Tammelin T. Towards a physically more active lifestyle based on one's own values: study design of a randomized controlled trial for physically inactive adults. BMC Public Health. 2013 Jul 19;13:671. doi: 10.1186/1471-2458-13-671.

    PubMed 23866812

Questions about this trial

What is this clinical trial studying?

A study testing ACT and REF in people with Behavior, run by Likes - Foundation for Sport and Health Sciences at 1 site in Finland.

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 1 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Physical activity (time frame: baseline and change after 3, 6, 9 and 15 months). 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 NCT01796990, which also lists 2 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 29 Apr 2015.

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