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Physically More Active Lifestyle Based on the Own Values - Randomized Controlled Trial Among Sedentary Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Jyvaskyla
Information provided by (Responsible Party):
Likes - Foundation for Sport and Health Sciences
ClinicalTrials.gov Identifier:
NCT01796990
First received: February 13, 2013
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Behavior
Behavioral: ACT
Behavioral: REF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Physically More Active Lifestyle Based on the Own Values - Randomized Controlled Trial Among Sedentary Adults

Further study details as provided by Likes - Foundation for Sport and Health Sciences:

Primary Outcome Measures:
  • Physical activity [ Time Frame: baseline and change after 3, 6, 9 and 15 months ] [ Designated as safety issue: No ]
    Physical activity is measured objectively by accelerometer (Actigraph GT1M, GT3X, Actigraph, Pensacola, Florida) the last seven days.


Secondary Outcome Measures:
  • The Acceptance and Action Questionnaire, AAQ-2 [ Time Frame: baseline and change after 3, 6, 9 and 15 months ] [ Designated as safety issue: No ]
    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).

  • the Kentucky Inventory of Mindfulness Skills (KIMS) [ Time Frame: baseline and change after 3, 6, 9 and 15 months ] [ Designated as safety issue: No ]
    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.

  • the Beck Depression Inventory, BDI-II [ Time Frame: baseline and change after 3, 6, 9 and 15 months ] [ Designated as safety issue: No ]
    Depressive symptoms are measured with the Beck Depression Inventory, BDI-II.

  • Physical activity [ Time Frame: baseline and change after 3, 6, 9 and 15 months ] [ Designated as safety issue: No ]
    Physical activity is assessed with a questionnaire (self-reported) during the last seven days.


Enrollment: 136
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: REF
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.
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.

Behavioral: ACT

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.

Behavioral: REF
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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796990

Locations
Finland
LIKES Foundation for Sport and Health Sciences
Jyväskylä, Finland, 40720
Sponsors and Collaborators
Likes - Foundation for Sport and Health Sciences
University of Jyvaskyla
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
  More Information

No publications provided

Responsible Party: Likes - Foundation for Sport and Health Sciences
ClinicalTrials.gov Identifier: NCT01796990     History of Changes
Other Study ID Numbers: Likes-01, LIKES-01
Study First Received: February 13, 2013
Last Updated: February 20, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Likes - Foundation for Sport and Health Sciences:
physical activity
psychological well-being
acceptance and commitment therapy
adults

ClinicalTrials.gov processed this record on April 17, 2014