ObesitySTEPSNCT01289145
Stage-based Exercise Promotion Study
A study testing Motivational intervention and Volitional intervention in people with Obesity and Diabetes Mellitus, Type 2, run by Freie Universität Berlin at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- Motivational intervention and Volitional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- to be capable of exercising on their own at a minimum level
- able to fill out a questionnaire (no illiteracy)
- adequate German language ability
Who cannot join
- no internet access
- no email address
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Being tested
- Motivational intervention, Volitional intervention, Active Control
- Keywords
- Action Planning, Positive Outcome Expectancies, Randomized Controlled Trial, Stages of change, Health behavior, Motivation
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interventionBehavioural
The motivational intervention promotes positive outcome expectancies on physical activity.
Volitional interventionBehavioural
The volitional intervention promotes the formulation of action plans for physical activity.
Active ControlBehavioural
Participants receive a quiz on physical activity and sports.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Motivational intervention; Behavioral: Volitional intervention; Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: two months
Secondary outcomes (2)
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.
Measured: two months
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.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Freie Universität Berlin
- Sponsor type
- University, hospital or other
- Investigators
- Ralf Schwarzer, PhD, Study chair, Freie Universität Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289145
- Sponsor's protocol ID
- STEP-2011-PK
- Acronym
- STEPS
- Status last verified
- Feb 2011
- First submitted
- 1 Feb 2011
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stage-based Exercise Promotion Study
- ClinicalTrials.gov ID
- NCT01289145
- Acronym / sponsor ID
- STEPS / STEP-2011-PK
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Keywords
- Action Planning, Positive Outcome Expectancies, Randomized Controlled Trial, Stages of change, Health behavior, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Freie Universität BerlinUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivational intervention, Behavioral: Volitional intervention, Behavioral: Active ControlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- to be capable of exercising on their own at a minimum level
- able to fill out a questionnaire (no illiteracy)
- adequate German language ability
Key exclusion criteria (2 listed)
- no internet access
- no email address
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interventionThe motivational intervention promotes positive outcome expectancies on physical activity. | Behavioural | Intervention |
| Volitional interventionThe volitional intervention promotes the formulation of action plans for physical activity. | Behavioural | Intervention |
| Active ControlParticipants receive a quiz on physical activity and sports. | Behavioural | Intervention |
Primary outcome
Self-reported physical activity frequency and duration
Time frame: two months
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)
2 secondary outcomes
Algorithm for Stages of Change (SOC) based on behavior and intention
Time frame: two months
Social Cognition
Time frame: two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Schwarzer, PhD study chair
Freie Universität Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational intervention and Volitional intervention in people with Obesity and Diabetes Mellitus, Type 2, run by Freie Universität Berlin at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported physical activity frequency and duration (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2012.