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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Jyväskylä, Finland, 40720
        • LIKES Foundation for Sport and Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (Estimate)

February 22, 2013

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

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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