Stage-based Exercise Promotion Study (STEPS)

This study has been completed.
Sponsor:
Information provided by:
Freie Universität Berlin
ClinicalTrials.gov Identifier:
NCT01289145
First received: February 1, 2011
Last updated: November 13, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention
Obesity
Diabetes Mellitus, Type 2
Behavioral: Motivational intervention
Behavioral: Volitional intervention
Behavioral: Active Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Stage-based Exercise Promotion Study

Resource links provided by NLM:


Further study details as provided by Freie Universität Berlin:

Primary Outcome Measures:
  • Self-reported physical activity frequency and duration [ Time Frame: two months ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • Algorithm for Stages of Change (SOC) based on behavior and intention [ Time Frame: two months ] [ Designated as safety issue: Yes ]
    Participants will be asked if they already are physically active and if they want to be more physically active, using a validated staging algorithm.

  • Social Cognition [ Time Frame: two months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 500
Study Start Date: February 2011
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
The motivational intervention promotes positive outcome expectancies on physical activity.
Behavioral: Volitional intervention
The volitional intervention promotes the formulation of action plans for physical activity.
Behavioral: Active Control
Participants receive a quiz on physical activity and sports.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289145

Locations
Germany
Freie Universität Berlin
Berlin, Germany, 14195
Sponsors and Collaborators
Freie Universität Berlin
Investigators
Study Chair: Ralf Schwarzer, PhD Freie Universität Berlin
  More Information

No publications provided

Responsible Party: Prof. Dr. Ralf Schwarzer, Freie Universität Berlin
ClinicalTrials.gov Identifier: NCT01289145     History of Changes
Other Study ID Numbers: STEP-2011-PK
Study First Received: February 1, 2011
Last Updated: November 13, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Freie Universität Berlin:
Action Planning
Positive Outcome Expectancies
Randomized Controlled Trial
Stages of change
Health behavior
Motivation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014