Clinical trial NCT02838550: Increasing Physical Activity Through a Motivational Online Intervention Using Pedometers in Sedentary Students
Official title: Increasing Physical Activity Through a Motivational Online Intervention Using Pedometers in Sedentary Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary
Keywords: Physical Activity
Motivational Online Intervention
Pedometers
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 (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.

Eligibility criteria: 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.

Primary outcomes:
measure: Daily Steps
timeFrame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
Secondary outcomes:
measure: Enjoyment of Physical Activity. Physical Activity Enjoyment Scale - Short Version (sPACES, Kendzierski & DeCarlo, 1991; Spanish adaptation of Fernández, Sánchez, & Bañuelos, 2008).
timeFrame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
measure: Stages of change to practice Physical Activity. Stages of change questionnaire for exercise (SCQ; Marcus, Rossi, Selby, Niaura, & Abrams, 1992).
timeFrame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
measure: Decisional balance to practice Physical Activity. Decision Balance Questionnaire for exercise (DBQ; Marcus, Rakowski, & Rossi, 1992).
timeFrame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
measure: Self-efficacy to practice Physical Activity. Self-Efficacy Questionnaire (SEQ; Marcus, Selby, Niaura, & Rossi, 1992).
timeFrame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
measure: Processes of change for Physical Activity. Processes of Change Questionnaire (PCQ; Marcus, Rossi, Selby, Niaura, & Abrams, 1992).
timeFrame: Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).
measure: Barriers to practice Physical Activity. Self-reported barriers to the practice of physical exercise (SBPPE, Niñerola, Capdevila, & Pintanel, 2006).
timeFrame: Baseline
measure: Familiarity with the pedometers (ad-hoc questionnaire)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of Valencia
name: Rosa Baños, Full Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Ausiàs Cebolla, PhD Ass.
role: STUDY_CHAIR
affiliation: University of Valencia
name: Marta Miragall, PhD St.
role: STUDY_CHAIR
affiliation: University of Valencia
name: Alejandro Domínguez, PhD St.
role: STUDY_CHAIR
affiliation: University of Valencia
name: Jessica Navarro, PhD St.
role: STUDY_CHAIR
References: