SedentaryNCT02838550
Increasing Physical Activity Through a Motivational Online Intervention Using Pedometers in Sedentary Students
A study testing Motivational Online Intervention and Pedometer in people with Sedentary, run by University of Valencia.
Trial summary
The aim of this study is to analyze the effect of a motivational online intervention (MOI) using pedometers to increase physical activity in a sample of sedentary students. It will be compared three conditions: MOI+PEDOMETER condition (access to a MOI and the use of a pedometer of new generation); MOI condition… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary
- What is being tested?
- Motivational Online Intervention and Pedometer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jul 2016
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- to practice less than 30 minutes of moderate-intensity physical activity, three times a week;
- to be sedentary or low active (to walk less than 7500 daily steps during a week
- an age between 18 and 40 years old.
Who cannot join
- to be already using a pedometer;
- to suffer from a physical and/or a psychological disorder to prevent from practicing physical activity;
- to be already participating in other intervention to practice physical activity; and
- history of drug or alcohol addiction.
About this study
The aim of this study is to analyze the effect of a motivational online intervention (MOI) using pedometers to increase physical activity in a sample of sedentary students. It will be compared three conditions: MOI+PEDOMETER condition (access to a MOI and the use of a pedometer of new generation); MOI condition (access to a MOI and the use of a blinded pedometer); and CONTROL condition (the use of a blinded pedometer).
Read the detailed description
Regular practice of physical activity (PA) has shown benefits in physical and mental health. However, the levels of PA are low in the general population. Pedometers and motivational online interventions (MOI) have been used to increase PA levels in sedentary population.
In spite of finding positive outcomes on PA levels when theoretical constructs derived from theories of behavior change and Internet have been used to guide pedometer-based interventions, few interventions have incorporated all these variables together and have analyzed the short-term or mid-term results.
The main objective of this study is to analyze the effect of a short self-administered Motivational Online Intervention (MOI) using pedometers to increase PA levels (primary outcome) and to change different theoretical constructs related to the PA behavior (positive decisional balance, self-efficacy, processes of change, stage of change, and enjoyment) (secondary outcomes) in a sample of sedentary students after 3-weeks intervention (post) and after 3-months (follow-up). It will be compared three conditions: MOI+PEDOMETER condition (access to a MOI and the use of a pedometer of new generation); MOI condition (access to a MOI and the use of blinded pedometer); and CONTROL condition (the use of a blinded pedometer). Hence, two conditions will include components of the "Transtheoretical Model of Change" in the intervention, such as the facilitation of the decisional balance, the increase of the self-efficacy, and the use of experiential and behavioral processes of change (e.g., consciousness raising, counterconditioning, reinforcement management, stimulus control), but only one of these condition will receive the feedback of the pedometer that will allow self-monitoring the behavior.
- Conditions
- Sedentary
- Being tested
- Motivational Online Intervention, Pedometer
- Keywords
- Physical Activity, Motivational Online Intervention, Pedometers
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Online InterventionBehavioural
The self-administered Motivational Online Intervention developed by the authors was based on the "Transtheoretical Model of Change". It attempts to facilitate the decisional balance, the increase of the self-efficacy, and the use of experiential and behavioral processes of change (e.g., consciousness raising, counterconditioning, reinforcement management, stimulus control). The main objective is to deliver information to increase the motivation to practice physical activity and to set individualized goals. It has a total length of 45 minutes, and it is delivered in a web platform at the beginning of the intervention.
PedometerBehavioural
Wearing a pedometer of new generation that provides motivational messages from time to time to motivate the user to increase the physical activity, as well as information in the screen regarding all-day activity: steps taken, calories burned, distance travelled, floors climbed and active minutes.
| Study group | Role | What they receive |
|---|---|---|
| MOI and PEDOMETER | Experimental | Accessing to a motivational online intervention and wearing an unblinded pedometer (in order to receive feedback of the steps taken). Receives: Behavioral: Motivational Online Intervention; Behavioral: Pedometer |
| MOI (without PEDOMETER) | Experimental | Accessing to a motivational online intervention and wearing a blinded pedometer (in order to not receive feedback of the steps taken). Receives: Behavioral: Motivational Online Intervention |
| CONTROL | No intervention | Wearing a blinded pedometer (in order to not receive feedback of the steps taken). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Steps
Measured: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
Secondary outcomes (7)
Enjoyment of Physical Activity. Physical Activity Enjoyment Scale - Short Version (sPACES, Kendzierski & DeCarlo, 1991; Spanish adaptation of Fernández, Sánchez, & Bañuelos, 2008).
Measured: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
Stages of change to practice Physical Activity. Stages of change questionnaire for exercise (SCQ; Marcus, Rossi, Selby, Niaura, & Abrams, 1992).
Measured: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
Decisional balance to practice Physical Activity. Decision Balance Questionnaire for exercise (DBQ; Marcus, Rakowski, & Rossi, 1992).
Measured: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
Self-efficacy to practice Physical Activity. Self-Efficacy Questionnaire (SEQ; Marcus, Selby, Niaura, & Rossi, 1992).
Measured: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
Processes of change for Physical Activity. Processes of Change Questionnaire (PCQ; Marcus, Rossi, Selby, Niaura, & Abrams, 1992).
Measured: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
Barriers to practice Physical Activity. Self-reported barriers to the practice of physical exercise (SBPPE, Niñerola, Capdevila, & Pintanel, 2006).
Measured: Baseline
Familiarity with the pedometers (ad-hoc questionnaire)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJan 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedentaryStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa María Baños Rivera, University of Valencia
- Investigators
- Rosa Baños, Full Prof., Principal investigator, University of ValenciaAusiàs Cebolla, PhD Ass., Study chair, University of ValenciaMarta Miragall, PhD St., Study chair, University of ValenciaAlejandro Domínguez, PhD St., Study chair, University of ValenciaJessica Navarro, PhD St., Study chair, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838550
- Sponsor's protocol ID
- H1466427733387
- Status last verified
- Jul 2016
- First submitted
- 13 Jul 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity Through a Motivational Online Intervention Using Pedometers in Sedentary Students
- ClinicalTrials.gov ID
- NCT02838550
- Acronym / sponsor ID
- H1466427733387
- Conditions
- Sedentary
- Keywords
- Physical Activity, Motivational Online Intervention, Pedometers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Jul 2016 (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 aim of this study is to analyze the effect of a motivational online intervention (MOI) using pedometers to increase physical activity in a sample of sedentary students. It will be compared three conditions: MOI+PEDOMETER condition (access to a MOI and the use of a pedometer of new generation); MOI condition (access to a MOI and the use of a blinded pedometer); and CONTROL condition (the use of a blinded pedometer).
Detailed description
Regular practice of physical activity (PA) has shown benefits in physical and mental health. However, the levels of PA are low in the general population. Pedometers and motivational online interventions (MOI) have been used to increase PA levels in sedentary population.
In spite of finding positive outcomes on PA levels when theoretical constructs derived from theories of behavior change and Internet have been used to guide pedometer-based interventions, few interventions have incorporated all these variables together and have analyzed the short-term or mid-term results.
The main objective of this study is to analyze the effect of a short self-administered Motivational Online Intervention (MOI) using pedometers to increase PA levels (primary outcome) and to change different theoretical constructs related to the PA behavior (positive decisional balance, self-efficacy, processes of change, stage of change, and enjoyment) (secondary outcomes) in a sample of sedentary students after 3-weeks intervention (post) and after 3-months (follow-up). It will be compared three conditions: MOI+PEDOMETER condition (access to a MOI and the use of a pedometer of new generation); MOI condition (access to a MOI and the use of blinded pedometer); and CONTROL condition (the use of a blinded pedometer). Hence, two conditions will include components of the "Transtheoretical Model of Change" in the intervention, such as the facilitation of the decisional balance, the increase of the self-efficacy, and the use of experiential and behavioral processes of change (e.g., consciousness raising, counterconditioning, reinforcement management, stimulus control), but only one of these condition will receive the feedback of the pedometer that will allow self-monitoring the behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MOI and PEDOMETER | Experimental | Behavioral: Motivational Online Intervention, Behavioral: PedometerAccessing to a motivational online intervention and wearing an unblinded pedometer (in order to receive feedback of the steps taken). |
| MOI (without PEDOMETER) | Experimental | Behavioral: Motivational Online InterventionAccessing to a motivational online intervention and wearing a blinded pedometer (in order to not receive feedback of the steps taken). |
| CONTROL | No intervention | –Wearing a blinded pedometer (in order to not receive feedback of the steps taken). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- to practice less than 30 minutes of moderate-intensity physical activity, three times a week;
- to be sedentary or low active (to walk less than 7500 daily steps during a week
- an age between 18 and 40 years old.
Key exclusion criteria (4 listed)
- to be already using a pedometer;
- to suffer from a physical and/or a psychological disorder to prevent from practicing physical activity;
- to be already participating in other intervention to practice physical activity; and
- history of drug or alcohol addiction.
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 Online InterventionThe self-administered Motivational Online Intervention developed by the authors was based on the "Transtheoretical Model of Change". It attempts to facilitate the decisional balance, the increase of the self-efficacy, and the use of experiential and behavioral processes of change (e.g., consciousness raising, counterconditioning, reinforcement management, stimulus control). The main objective is to deliver information to increase the motivation to practice physical activity and to set individualized goals. It has a total length of 45 minutes, and it is delivered in a web platform at the beginning of the intervention. | Behavioural | MOI (without PEDOMETER), MOI and PEDOMETER |
| PedometerWearing a pedometer of new generation that provides motivational messages from time to time to motivate the user to increase the physical activity, as well as information in the screen regarding all-day activity: steps taken, calories burned, distance travelled, floors climbed and active minutes. | Behavioural | MOI and PEDOMETER |
Primary outcome
Daily Steps
Time frame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
7 secondary outcomes
Enjoyment of Physical Activity. Physical Activity Enjoyment Scale - Short Version (sPACES, Kendzierski & DeCarlo, 1991; Spanish adaptation of Fernández, Sánchez, & Bañuelos, 2008).
Time frame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
Stages of change to practice Physical Activity. Stages of change questionnaire for exercise (SCQ; Marcus, Rossi, Selby, Niaura, & Abrams, 1992).
Time frame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
Decisional balance to practice Physical Activity. Decision Balance Questionnaire for exercise (DBQ; Marcus, Rakowski, & Rossi, 1992).
Time frame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
Self-efficacy to practice Physical Activity. Self-Efficacy Questionnaire (SEQ; Marcus, Selby, Niaura, & Rossi, 1992).
Time frame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
Processes of change for Physical Activity. Processes of Change Questionnaire (PCQ; Marcus, Rossi, Selby, Niaura, & Abrams, 1992).
Time frame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
Barriers to practice Physical Activity. Self-reported barriers to the practice of physical exercise (SBPPE, Niñerola, Capdevila, & Pintanel, 2006).
Time frame: Baseline
Familiarity with the pedometers (ad-hoc questionnaire)
Time frame: Baseline
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 20 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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.
Rosa Baños, Full Prof. principal investigator
University of Valencia
Ausiàs Cebolla, PhD Ass. study chair
University of Valencia
Marta Miragall, PhD St. study chair
University of Valencia
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Online Intervention and Pedometer in people with Sedentary, run by University of Valencia.
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 4 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 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Daily Steps (time frame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 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 20 Jul 2016.