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

Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796990
• Other study ID #: Likes-01
• Secondary ID: LIKES-01
• Status: Completed
• Phase: N/A
• First received: February 13, 2013
• Last updated: April 28, 2015
• Start date: August 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Likes - Foundation for Sport and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Behavior

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	LIKES Foundation for Sport and Health Sciences	Jyväskylä

Sponsors (2)

Lead Sponsor	Collaborator
Likes - Foundation for Sport and Health Sciences	University of Jyvaskyla

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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).	baseline and change after 3, 6, 9 and 15 months	No
Secondary	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.	baseline and change after 3, 6, 9 and 15 months	No
Secondary	the Beck Depression Inventory, BDI-II	Depressive symptoms are measured with the Beck Depression Inventory, BDI-II.	baseline and change after 3, 6, 9 and 15 months	No
Secondary	Physical activity	Physical activity is assessed with a questionnaire (self-reported) during the last seven days.	baseline and change after 3, 6, 9 and 15 months	No