Increasing Physical Activity Through a Motivational Online Intervention Using Pedometers in Sedentary Students

Sedentary Clinical Trial

Official title:

Increasing Physical Activity Through a Motivational Online Intervention Using Pedometers in Sedentary Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838550
• Other study ID #: H1466427733387
• Status: Completed
• Phase: N/A
• First received: July 13, 2016
• Last updated: July 15, 2016
• Start date: January 2013
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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 (access to a MOI and the use of a blinded pedometer); and CONTROL condition (the use of a blinded pedometer).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedentary

Intervention

Behavioral:
• Motivational Online Intervention
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.
• Pedometer
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Steps		Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).	No
Secondary	Enjoyment of Physical Activity. Physical Activity Enjoyment Scale - Short Version (sPACES, Kendzierski & DeCarlo, 1991; Spanish adaptation of Fernández, Sánchez, & Bañuelos, 2008).		Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).	No
Secondary	Stages of change to practice Physical Activity. Stages of change questionnaire for exercise (SCQ; Marcus, Rossi, Selby, Niaura, & Abrams, 1992).		Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).	No
Secondary	Decisional balance to practice Physical Activity. Decision Balance Questionnaire for exercise (DBQ; Marcus, Rakowski, & Rossi, 1992).		Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).	No
Secondary	Self-efficacy to practice Physical Activity. Self-Efficacy Questionnaire (SEQ; Marcus, Selby, Niaura, & Rossi, 1992).		Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).	No
Secondary	Processes of change for Physical Activity. Processes of Change Questionnaire (PCQ; Marcus, Rossi, Selby, Niaura, & Abrams, 1992).		Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).	No
Secondary	Barriers to practice Physical Activity. Self-reported barriers to the practice of physical exercise (SBPPE, Niñerola, Capdevila, & Pintanel, 2006).		Baseline	No
Secondary	Familiarity with the pedometers (ad-hoc questionnaire)		Baseline	No