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CompletedNCT01289145STEPSUpdated Nov 15, 2012

Stage-based Exercise Promotion Study

An interventional study of Motivational intervention and Volitional intervention in Obesity and Diabetes Mellitus, Type 2, sponsored by Freie Universität Berlin. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-15.

Sponsored by Freie Universität Berlin · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
  • Diabetes Mellitus, Type 2

Keywords

  • Action Planning
  • Positive Outcome Expectancies
  • Randomized Controlled Trial
  • Stages of change
  • Health behavior
  • Motivation
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 500 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Freie Universität Berlin is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • no internet access
  • no email address
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Intervention

    Participants will be allocated to a motivational intervention, a volitional intervention or the active control group. The motivational intervention promotes positive outcome expectancies on physical activity. The volitional intervention promotes the formulation of action plans for physical activity. Participants in the active control group, receive a quiz on physical activity and sports.

    Behavioral: Motivational intervention · Behavioral: Volitional intervention · Behavioral: Active Control

Interventions

  • BehavioralMotivational intervention

    The motivational intervention promotes positive outcome expectancies on physical activity.

  • BehavioralVolitional intervention

    The volitional intervention promotes the formulation of action plans for physical activity.

  • BehavioralActive Control

    Participants receive a quiz on physical activity and sports.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: two months

Secondary outcomes

  1. 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.

    Time frame: two months

  2. 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.

    Time frame: two months

07

Study locations

1 site
  • Freie Universität Berlin
    Berlin, 14195, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01289145
Lead sponsor
Freie Universität Berlin
First posted
Feb 3, 2011
Start date
Feb 2011
Primary completion
Apr 2011
Completion
May 2011
Last update
Nov 15, 2012

Study contacts

Ralf Schwarzer, PhD
study chair · Freie Universität Berlin

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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