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Stage-based Exercise Promotion Study (STEPS)

Primary Purpose

Obesity, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Motivational intervention
Volitional intervention
Active Control
Sponsored by
Freie Universität Berlin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Action Planning, Positive Outcome Expectancies, Randomized Controlled Trial, Stages of change, Health behavior, Motivation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Freie Universität Berlin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 1, 2011
Last Updated
November 13, 2012
Sponsor
Freie Universität Berlin
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1. Study Identification

Unique Protocol Identification Number
NCT01289145
Brief Title
Stage-based Exercise Promotion Study
Acronym
STEPS
Official Title
Stage-based Exercise Promotion Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Freie Universität Berlin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes Mellitus, Type 2
Keywords
Action Planning, Positive Outcome Expectancies, Randomized Controlled Trial, Stages of change, Health behavior, Motivation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational intervention
Intervention Description
The motivational intervention promotes positive outcome expectancies on physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Volitional intervention
Intervention Description
The volitional intervention promotes the formulation of action plans for physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
Participants receive a quiz on physical activity and sports.
Primary Outcome Measure Information:
Title
Self-reported physical activity frequency and duration
Description
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 Outcome Measure Information:
Title
Algorithm for Stages of Change (SOC) based on behavior and intention
Description
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
Title
Social Cognition
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf Schwarzer, PhD
Organizational Affiliation
Freie Universität Berlin
Official's Role
Study Chair
Facility Information:
Facility Name
Freie Universität Berlin
City
Berlin
ZIP/Postal Code
14195
Country
Germany

12. IPD Sharing Statement

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Stage-based Exercise Promotion Study

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