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A Combined HAPA and mHealth Intervention to Reduce Sedentary Behaviour in University Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03760393
Recruitment Status : Completed
First Posted : November 30, 2018
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Harry Prapavessis, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Health Behaviour Change Behavioral: (SB-related planning + daily text messages) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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).

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using a Combined Health Action Process Approach and mHealth Intervention to Reduce Sedentary Behaviour in University Students - A Randomized Controlled Trial
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HAPA-treatment
(SB-related planning + daily text messages)
Behavioral: (SB-related planning + daily text messages)

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.


No Intervention: Control
(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.



Primary Outcome Measures :
  1. Changes in Frequency of Breaks from Sitting as a Student [ Time Frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8) ]
    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.

  2. Changes in Duration of Breaks from Sitting as a Student [ Time Frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8) ]
    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.

  3. Changes in Time Spent Standing as a Student [ Time Frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8) ]
    Five-item modified Occupational Sitting and Physical Activity Questionnaire (OSPAQ; Chau, Van Der Ploeg, Dunn, Kurko, & Bauman, 2012)

  4. Changes in Time Spent Engaged in Light-Intensity Physical Activity (i.e., walking) as a Student [ Time Frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8) ]
    Five-item modified Occupational Sitting and Physical Activity Questionnaire (OSPAQ; Chau, Van Der Ploeg, Dunn, Kurko, & Bauman, 2012)


Secondary Outcome Measures :
  1. Action Planning towards reducing occupational (student) sitting time [ Time Frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8) ]
    Four-items; five-point Likert scale (1 = "completely disagree" to 5 = "totally agree")

  2. Coping Planning towards reducing occupational (student) sitting time [ Time Frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8) ]
    Five-items; five-point Likert scale (1 = "completely disagree" to 5 = "totally agree")

  3. Action Control towards reducing occupational (student) sitting time [ Time Frame: Baseline, Weeks 2, 4, 6, and at the 2-week follow-up (Week 8) ]
    Six-items; five-point Likert scale (1 = "completely disagree" to 5 = "totally agree")

  4. Self-rated Work Performance [ Time Frame: Baseline, Week 6 ]
    One-item, 11-point Likert scale (0-10; 0 = Absolutely unacceptable, 10 = Absolutely Ideal). Higher values represent a better outcome.

  5. Role limitations due to physical health [ Time Frame: Baseline, Week 6 ]
    RAND 36-item Short Form Survey (SF-36; Ware and Sherbourne, 1992) modified version (16-item). Four-items will assess participant's perceived role limitations due to physical health problems; 2-point scale (yes, no)

  6. Role limitations due to emotional health [ Time Frame: Baseline, Week 6 ]
    RAND 36-item Short Form Survey (SF-36; Ware and Sherbourne, 1992) modified version (16-item). Three-items will assess role limitations due to personal or emotional problems; 2-point scale (yes, no)

  7. Emotional well-being [ Time Frame: Baseline, Week 6 ]
    RAND 36-item Short Form Survey (SF-36; Ware and Sherbourne, 1992) modified version (16-item). Five-items will assess perceived emotional well-being; 5-point Likert scale (All of the time =1, Most of the time = 2, Some of the time = 3, A little of the time = 4, None of the time = 5)

  8. Energy/Fatigue [ Time Frame: Baseline, Week 6 ]
    RAND 36-item Short Form Survey (SF-36; Ware and Sherbourne, 1992) modified version (16-item). Four-items will assess perceived energy/fatigue; 5-point Likert scale (All of the time =1, Most of the time = 2, Some of the time = 3, A little of the time = 4, None of the time = 5)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760393


Locations
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Canada, Ontario
The University of Western Ontario
London, Ontario, Canada
Sponsors and Collaborators
Western University, Canada
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Responsible Party: Dr. Harry Prapavessis, Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT03760393    
Other Study ID Numbers: HAPA Planning & SB in Students
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Harry Prapavessis, Western University, Canada:
Sedentary Behaviour
Health Behaviour Change
Health Action Process Approach
mHealth
Intervention
Non-Sedentary Behaviours
Break Frequency
Break Duration
Action Planning
Coping Planning
Work Performance
Health Outcomes