NCT01289145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

November 15, 2012

Status Verified

February 1, 2011

Enrollment Period

2 months

First QC Date

February 1, 2011

Last Update Submit

November 13, 2012

Conditions

Keywords

Action PlanningPositive Outcome ExpectanciesRandomized Controlled TrialStages of changeHealth behaviorMotivation

Outcome Measures

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)

    two months

Secondary Outcomes (2)

  • Algorithm for Stages of Change (SOC) based on behavior and intention

    two months

  • Social Cognition

    two months

Study Arms (1)

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.

Behavioral: Motivational interventionBehavioral: Volitional interventionBehavioral: Active Control

Interventions

The motivational intervention promotes positive outcome expectancies on physical activity.

Intervention

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

Intervention
Active ControlBEHAVIORAL

Participants receive a quiz on physical activity and sports.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to be capable of exercising on their own at a minimum level
  • able to fill out a questionnaire (no illiteracy)
  • adequate German language ability

You may not qualify if:

  • no internet access
  • no email address

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freie Universität Berlin

Berlin, 14195, Germany

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Health Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Ralf Schwarzer, PhD

    Freie Universität Berlin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 3, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

November 15, 2012

Record last verified: 2011-02

Locations