NCT01796990

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

2.3 years

First QC Date

February 13, 2013

Last Update Submit

April 28, 2015

Conditions

Keywords

physical activitypsychological well-beingacceptance and commitment therapyadults

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    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 Outcomes (4)

  • The Acceptance and Action Questionnaire, AAQ-2

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

  • the Kentucky Inventory of Mindfulness Skills (KIMS)

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

  • the Beck Depression Inventory, BDI-II

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

  • Physical activity

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

Study Arms (2)

REF group

ACTIVE COMPARATOR

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

ACT group

OTHER

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: ACTBehavioral: REF

Interventions

ACTBEHAVIORAL

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.

ACT group
REFBEHAVIORAL

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 groupREF group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LIKES Foundation for Sport and Health Sciences

Jyväskylä, 40720, Finland

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

BehaviorMotor ActivityPsychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction

Study Officials

  • Anu Kangasniemi, M.Sc.

    Likes - Foundation for Sport and Health Sciences

    PRINCIPAL INVESTIGATOR
  • Tuija Tammelin, PhD

    Likes - Foundation for Sport and Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 22, 2013

Study Start

August 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations