- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02838550
Increasing Physical Activity Through a Motivational Online Intervention Using Pedometers in Sedentary Students
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MOI and PEDOMETER
Accessing to a motivational online intervention and wearing an unblinded pedometer (in order to receive feedback of the steps taken).
|
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.
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.
|
|
Experimental: MOI (without PEDOMETER)
Accessing to a motivational online intervention and wearing a blinded pedometer (in order to not receive feedback of the steps taken).
|
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.
|
|
No Intervention: CONTROL
Wearing a blinded pedometer (in order to not receive feedback of the steps taken).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Daily Steps
Time Frame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
|
Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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).
|
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).
|
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).
|
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).
|
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).
|
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
|
Baseline
|
|
Familiarity with the pedometers (ad-hoc questionnaire)
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rosa Baños, Full Prof., University of Valencia
- Study Chair: Ausiàs Cebolla, PhD Ass., University of Valencia
- Study Chair: Marta Miragall, PhD St., University of Valencia
- Study Chair: Alejandro Domínguez, PhD St., University of Valencia
- Study Chair: Jessica Navarro, PhD St., University of Valencia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H1466427733387
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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