Stage-based Exercise Promotion Study

Obesity Clinical Trial

— STEPS  

Official title:

Stage-based Exercise Promotion Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289145
• Other study ID #: STEP-2011-PK
• Status: Completed
• Phase: N/A
• First received: February 1, 2011
• Last updated: November 13, 2012
• Start date: February 2011
• Est. completion date: May 2011

Study information

• Verified date: February 2011
• Source: Freie Universität Berlin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to increase regular physical activity among students by fostering self-management competencies. The intervention was implemented as paper-pencil intervention. The aim of this research project is to evaluate a motivational and volitional intervention in comparison to a control intervention.

Study participants will be recruited in lectures at Freie Universitaet Berlin and followed up twice (two and ten weeks after baseline).

The motivational intervention is expected to increase unmotivated participants' intention to be physically active. The volitional intervention is expected to promote physical activity among motivated but inactive participants. Both interventions are hypothesized to improve self-management competencies over time.

Description:

An experimental study is planned over a time period of ten weeks. In the physical activity study, participants will randomly be allocated to either one of two intervention groups (IG) or to an active control group (ACG), receiving a quiz on physical activity and sports. Intervention group 1 receives a paper-pencil intervention which focuses on positive outcome expectancies (motivational intervention). Intervention group 2 receives a paper-pencil intervention which promotes the formulation of action plans for physical activity (volitional intervention).

Furthermore, all participants will receive two emails as intervention boosters until the end of the study.

Study participants will be invited to take part in the study during lectures of the Freie Universitaet Berlin. The students will be followed up twice: two weeks after T1 (paper-pencil), T2 will take place (paper-pencil). Eight weeks after T2 the T3 assessment will be conducted online.

The hypotheses are:

Participants of the motivational intervention report a larger increase in motivation to adopt physical activity from T1 to T2 and T3, as compared to the participants of the volitional or the control intervention. Effects will be larger in unmotivated participants than in already motivated participants.

Participants of the volitional intervention report a larger increase in physical activity from T1 to T2 and T3, as compared to the participants of the motivational or the control intervention. Effects will be larger in motivated participants than in unmotivated participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• to be capable of exercising on their own at a minimum level

• able to fill out a questionnaire (no illiteracy)

• adequate German language ability

Exclusion Criteria:

• no internet access

• no email address

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity

Intervention

Behavioral:
• Motivational intervention
The motivational intervention promotes positive outcome expectancies on physical activity.
• Volitional intervention
The volitional intervention promotes the formulation of action plans for physical activity.
• Active Control
Participants receive a quiz on physical activity and sports.

Locations

Country	Name	City	State
Germany	Freie Universität Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Freie Universität Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported physical activity frequency and duration	Participants will be asked on how many days per week they were physically active and how much time they had spent on average performing these activities on each of these days (adapted version of the Godin scale)	two months	Yes
Secondary	Algorithm for Stages of Change (SOC) based on behavior and intention	Participants will be asked if they already are physically active and if they want to be more physically active, using a validated staging algorithm.	two months	Yes
Secondary	Social Cognition	We will assess social cognition based on a validated psychometric scale that is worded in a behavior-specific manner (physical activity) and has several subscales.	two months	Yes