NCT03760393

Brief Summary

Societal changes have resulted in reduced demands to be active and increased daily time spent sitting. Sedentary behavior (SB) has been linked to many health problems such as type 2 diabetes and heart disease. University students are a high-risk population for excessive SB. Increasing the length and frequency of breaks from sitting and increasing the time spent standing and engaged in light physical activity are ways to decrease SB. The purpose of this study is to determine whether combining a Health Action Process Approach-based (theory-driven), specifically action and coping planning intervention, with a tailored text messaging intervention can reduce occupational (student) sitting time among university students. Participants in the intervention group will receive one behavioural counselling session, followed by daily, tailored text messages over a 6-week period, with a focus on encouraging them to reduce their sitting time as a student by increasing their frequency and duration of breaks from sitting, as well as time spent standing and engaged in light-intensity physical activity. It is expected that university students who receive the planning intervention and tailored text messages will report greater increases in non-sedentary behaviours (e.g., break frequency, break duration, standing, light physical activity) than those who do not receive the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 24, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

1.4 years

First QC Date

November 24, 2018

Last Update Submit

June 12, 2020

Conditions

Keywords

Sedentary BehaviourHealth Behaviour ChangeHealth Action Process ApproachmHealthInterventionNon-Sedentary BehavioursBreak FrequencyBreak DurationAction PlanningCoping PlanningWork PerformanceHealth Outcomes

Outcome Measures

Primary Outcomes (4)

  • Changes in Frequency of Breaks from Sitting as a Student

    Modified version of the SIT-Q 7d (Wijndaele et al., 2014; Sui \& Prapavessis, 2016); 1-item; 12-point scale (Less than every 30 min, Every 30-45 min, Every 45 min-1 hour, Every 1-1.5 hours, Every 1.5-2 hours, Every 2-3 hours, Every 3-4 hours, Every 4-5 hours, Over every 5 hours, No interruption). Lower values represent a better outcome.

    Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)

  • Changes in Duration of Breaks from Sitting as a Student

    Modified version of the SIT-Q 7d (Wijndaele et al., 2014; Sui \& Prapavessis, 2016); 1-item; 10-point scale (Less than 30 sec, 30 sec-1 min, 1-2 min, 2-3 min, 3-4 min, 4-5 min, 5-10 min, 10-15 min, 15-30 min, Over 30 min). Higher values represent a better outcome.

    Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)

  • Changes in Time Spent Standing as a Student

    Five-item modified Occupational Sitting and Physical Activity Questionnaire (OSPAQ; Chau, Van Der Ploeg, Dunn, Kurko, \& Bauman, 2012)

    Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)

  • Changes in Time Spent Engaged in Light-Intensity Physical Activity (i.e., walking) as a Student

    Five-item modified Occupational Sitting and Physical Activity Questionnaire (OSPAQ; Chau, Van Der Ploeg, Dunn, Kurko, \& Bauman, 2012)

    Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)

Secondary Outcomes (8)

  • Action Planning towards reducing occupational (student) sitting time

    Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)

  • Coping Planning towards reducing occupational (student) sitting time

    Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)

  • Action Control towards reducing occupational (student) sitting time

    Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8)

  • Self-rated Work Performance

    Baseline, Week 6

  • Role limitations due to physical health

    Baseline, Week 6

  • +3 more secondary outcomes

Study Arms (2)

HAPA-treatment

EXPERIMENTAL

(SB-related planning + daily text messages)

Behavioral: (SB-related planning + daily text messages)

Control

NO INTERVENTION

(No Treatment) Participants randomly assigned to the control group will receive no information or intervention of any kind and will only be asked to complete the outcome questionnaires.

Interventions

Participants will receive a one-on-one behavioral counseling session, and planning sheet as reference for developing strategies as part of their Action/Coping Plan. Participants will be asked to form 3-4 actions plans specifying when, where, how, and for how long they would reduce occupational (student) sitting time; and anticipate potential barriers and identify ways they could be overcome. Strategies will explicitly focus on the ultimate objective of increasing break frequency to every 30-45 minutes, achieving a break duration of 2-3 minutes, and increasing time spent standing and engaged in light-intensity PA, in the occupational domain (i.e. as a student; during school-related activities). Participants will also receive sedentary behaviour-related text messages twice daily, depending on their preferences and schedule, which will act as mini-booster interventions.

HAPA-treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 18+ years of age
  • Must be a full-time university and/or college student
  • Must be in self-reported good mental and physical health
  • Must be able to read and write in English
  • Must have access to a computer with Internet
  • Must own a mobile phone with free unlimited incoming text messages.

You may not qualify if:

  • Under 18 years of age
  • Do not read or write in English
  • Not a full-time university and/or college student
  • Do not have access to a computer with Internet
  • Do not own a mobile phone with free unlimited incoming text messages and/or emails
  • Pregnant
  • Medical condition that prohibits individual from being physically active.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Western Ontario

London, Ontario, Canada

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study will employ a prospective, 2-group, repeated measure (2x5), randomized controlled trial (RCT) design. All participants will be randomized into either a 6-week HAPA-treatment (SB-related planning + text messages intervention) or waitlisted control (no treatment) condition. All primary outcomes will be assessed at four time points (baseline, 2, 4, and 6 weeks), and again at a two-week follow-up (8 weeks). Action and coping planning and action control towards reducing occupational (student) sitting time will be assessed at the same time points. Secondary outcome assessments (i.e., work- and health-related outcomes) will occur pre-(baseline) and post-intervention (6 weeks).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 24, 2018

First Posted

November 30, 2018

Study Start

January 1, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations