NCT02838550

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

January 1, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

3.5 years

First QC Date

July 13, 2016

Last Update Submit

July 15, 2016

Conditions

Keywords

Physical ActivityMotivational Online InterventionPedometers

Outcome Measures

Primary Outcomes (1)

  • Daily Steps

    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).

    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).

    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).

    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).

    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).

    Change from Baseline to Post-intervention (at 3 weeks) and Follow-up (at 3 months).

  • +2 more secondary outcomes

Study Arms (3)

MOI and PEDOMETER

EXPERIMENTAL

Accessing to a motivational online intervention and wearing an unblinded pedometer (in order to receive feedback of the steps taken).

Behavioral: Motivational Online InterventionBehavioral: 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).

Behavioral: Motivational Online Intervention

CONTROL

NO INTERVENTION

Wearing a blinded pedometer (in order to not receive feedback of the steps taken).

Interventions

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.

MOI (without PEDOMETER)MOI and PEDOMETER
PedometerBEHAVIORAL

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.

MOI and PEDOMETER

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Rosa Baños, Full Prof.

    University of Valencia

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 20, 2016

Study Start

January 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 20, 2016

Record last verified: 2016-07