Clinical trial NCT01289145: Stage-based Exercise Promotion Study
Official title: Stage-based Exercise Promotion Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes Mellitus, Type 2
Keywords: Action Planning
Positive Outcome Expectancies
Randomized Controlled Trial
Stages of change
Health behavior
Motivation
Lead sponsor: Freie Universität Berlin
Sponsor class: OTHER
First posted: 2011-02-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported physical activity frequency and duration
timeFrame: two months
Secondary outcomes:
measure: Algorithm for Stages of Change (SOC) based on behavior and intention
timeFrame: two months
measure: Social Cognition
timeFrame: two months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Freie Universität Berlin
Study officials:
affiliation: Freie Universität Berlin
name: Ralf Schwarzer, PhD
role: STUDY_CHAIR
References: