- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01796990
Developing a Physically More Active Lifestyle Based on One's Own Values - RCT Among Sedentary Adults
Developing a Physically More Active Lifestyle Based on One's Own Values - Randomized Controlled Trial Among Sedentary Adults
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Jyväskylä, Finland, 40720
- LIKES Foundation for Sport and Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 30-50 years, working status, and don´t meet the current physical activity recommendations.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: REF group
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.
|
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.
|
|
Other: ACT group
The 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. |
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.
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: baseline and change after 3, 6, 9 and 15 months
|
Physical activity is measured objectively by accelerometer (Actigraph GT1M, GT3X, Actigraph, Pensacola, Florida) the last seven days.
|
baseline and change after 3, 6, 9 and 15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Acceptance and Action Questionnaire, AAQ-2
Time Frame: baseline and change after 3, 6, 9 and 15 months
|
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).
|
baseline and change after 3, 6, 9 and 15 months
|
|
the Kentucky Inventory of Mindfulness Skills (KIMS)
Time Frame: baseline and change after 3, 6, 9 and 15 months
|
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.
|
baseline and change after 3, 6, 9 and 15 months
|
|
the Beck Depression Inventory, BDI-II
Time Frame: baseline and change after 3, 6, 9 and 15 months
|
Depressive symptoms are measured with the Beck Depression Inventory, BDI-II.
|
baseline and change after 3, 6, 9 and 15 months
|
|
Physical activity
Time Frame: baseline and change after 3, 6, 9 and 15 months
|
Physical activity is assessed with a questionnaire (self-reported) during the last seven days.
|
baseline and change after 3, 6, 9 and 15 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anu Kangasniemi, M.Sc., Likes - Foundation for Sport and Health Sciences
- Study Director: Tuija Tammelin, PhD, Likes - Foundation for Sport and Health Sciences
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LIKES-01 (Other Identifier: LIKES-01)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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