- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04131270
Explaining Sedentary Behavior With Planning (the Revised HAPA Model)
Explaining Sedentary Behavior With the Revised Reflective + Impulsive Health Action Process Approach (HAPA) Model
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The effects of three sessions (3 education sessions versus 3 education sessions+ forming plans to replace sedentary behavior with physical activity) will be investigated among participants from three age groups: adolescents (12-17 years old), adults (18-60 years old), and older adults (>60 years old). Compared to education only, forming plans about how to replace time spent on sedentary activities with physical activity is expected to result in a significantly larger change (a reduction) of sedentary time at the follow-up. Accelerometers will be used to evaluate short-term and mid-term changes in total sedentary time and the relative proportion of time spent on sedentary behavior vs light-intensity and moderate-to-vigorous- intensity physical activity.
Additionally, the study will observe changes in if the cognitions included in the Health Action Process Approach model (HAPA), such risk perception, self-efficacy, outcome expectancies, intention, action control, as well as changes in behavioral habit, presence of sedentary behavior cues in physical environment, and physical activity behavior. The observations will be conducted three times, at the baseline (before the intervention), the 2-month follow up, and at the 8-month follow-up.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aleksandra Luszczynska, PhD
- Phone Number: +48694441765
- Email: aluszczynska@swps.edu.pl
Study Contact Backup
- Name: Ewa Kulis, MA
- Phone Number: +48723527172
- Email: ekulis@swps.edu.pl
Study Locations
-
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Lower Silezia
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Wroclaw, Lower Silezia, Poland, 53-328
- Recruiting
- SWPS University of Social Sciences and Humanities
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Contact:
- Katarzyna Byrka, PhD
- Email: kbyrka@swps.edu.pl
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Contact:
- Martyna Kuszneruk, MA
- Email: mkuszneruk@swps.edu.pl
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Sub-Investigator:
- Zofia Szczuka, MA
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Sub-Investigator:
- Ewa Kulis, MA
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Sub-Investigator:
- Monika Boberska, MA
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Sub-Investigator:
- Magdalena Kruk, MA
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- not meeting physical activity guidelines proposed by the World Health Organization
Exclusion Criteria:
- any existing diseases with contraindications for moderate intensity physical activity, confirmed by patient's primary care physician or a specialist in cardiovascular diseases/endocrinology/rehabilitation medicine providing care for the patient during the recruitment and follow-ups
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Planning + Education
3 education sessions + 1 planning session (integrated into the 3rd education session); delivered face-to-face over 3 weeks (after the baseline measurement), individually. Planning: The planning materials and forms have sections: (a) instructions of what should be included in a good plan (the when, where, and how components), (b) formulating action and coping plans. Action plans (referring to when, when, and how the individual will act) as well as coping plans (referring to how to overcome potential difficulties) will be formed. After forming the plans individually, experimenters will discuss the plans with the participants. |
Planning: Participants will fill in the planning forms that efer to replacing sedentary behavior with physical activity. The following behavior change techniques are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all behavior change techniques would include references to planning.
The education would include extended sedentary behavior and physical activity education, delivered face-to-face by the experimenters.
The education includes: (1) the behavioral guidelines, tailored to age and health status of the participants, (2) the examples of exercises and their metabolic equivalent, and (3) the education about ways to break sedentary behavior with active breaks.
|
Active Comparator: Education
3 education sessions; delivered face-to-face over 3 weeks (after the baseline measurement), individually. The education includes extended physical activity and sedentary behavior education using participant-educator discussions and printed materials. |
The education would include extended sedentary behavior and physical activity education, delivered face-to-face by the experimenters.
The education includes: (1) the behavioral guidelines, tailored to age and health status of the participants, (2) the examples of exercises and their metabolic equivalent, and (3) the education about ways to break sedentary behavior with active breaks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sedentary behavior
Time Frame: change from the baseline sedentary behavior at 8 months
|
minutes of sedentary behavior per day assessed with ActiGraph wGT3X-BT accelerometer
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change from the baseline sedentary behavior at 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The composition of waking time
Time Frame: change from the baseline composition of waking time at 8 months
|
the proportion of time spent on sedentary behavior (minutes per day) to time spent on light-intensity physical activity (minutes per day) and moderate-to-vigorous physical activity (minutes per day) assessed with ActiGraph wGT3X-BT accelerometer
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change from the baseline composition of waking time at 8 months
|
Physical activity
Time Frame: change from the baseline physical activity at 8 months
|
minutes of light, moderate and vigorous intensity physical activity per day measured with ActiGraph wGT3X-BT accelerometer
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change from the baseline physical activity at 8 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sedentary behavior habit
Time Frame: change from the baseline sedentary behavior habit at 8 months
|
Self-Reported Habit Scale; mean item score ranging from 1 to 4, higher scores indicate stronger sedentary behavior habit
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change from the baseline sedentary behavior habit at 8 months
|
Self-efficacy for reducing sedentary behavior
Time Frame: change from the baseline self-efficacy at 8 months
|
9 self-efficacy questionnaire items; mean item score ranging from 1 to 4, higher scores indicate stronger self-efficacy
|
change from the baseline self-efficacy at 8 months
|
Risk perception
Time Frame: change from the baseline risk perception at 8 months
|
3 questionnaire items to assess risk perception; mean item score ranging from 1 to 4, higher scores indicate higher risk perception
|
change from the baseline risk perception at 8 months
|
Outcome expectancies
Time Frame: change from the baseline outcome expectancies at 8 months
|
18 items assessing positive (9 items) and negative (9 items) outcome expectancies; item score ranging from 1 to 4, higher scores indicate more positive outcome expectancies
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change from the baseline outcome expectancies at 8 months
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Action control
Time Frame: change from the baseline outcome expectancies at 8 months
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10 questionnaire items assessing action control; mean item score ranging from 1 to 4, higher scores indicate stronger action control
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change from the baseline outcome expectancies at 8 months
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Intention
Time Frame: change from the baseline intention at 8 months
|
3 questionnaire items assessing intention to reduce sedentary behavior; mean item score ranging from 1 to 4, higher scores indicate stronger intention to reduce sedentary behavior
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change from the baseline intention at 8 months
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Self-reported planning
Time Frame: change from the baseline planning at 8 months
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4 questionnaire items assessing action planning; mean item score ranging from 1 to 4, higher scores indicate a higher level of self-reported planning
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change from the baseline planning at 8 months
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Environmental cues for sedentary behavior
Time Frame: change from the baseline planning at 8 months
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10 questionnaire items assessing physical environment cues for sedentary behavior and its reduction; the total sum score ranging from 0 to 10; higher scores indicate more environmental cues for sedentary behavior
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change from the baseline planning at 8 months
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Body mass index (BMI)
Time Frame: change from the baseline planning at 8 months
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Certified and standardized body weight scales (Beurer; European Union safety certificate; measurement error < 5%) and measuring rods will be used.
Body mass index will be calculated using the following formula: body weight [in kg] divided by a square of body height (in meters).
Body weight will be recorded in kilograms and body height will be recorded in meters.
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change from the baseline planning at 8 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Aleksandra Luszczynska, PhD, SWPS University of Social Sciences and Humanities
Publications and helpful links
General Publications
- Gardner B. A review and analysis of the use of 'habit' in understanding, predicting and influencing health-related behaviour. Health Psychol Rev. 2015;9(3):277-95. doi: 10.1080/17437199.2013.876238. Epub 2014 Jan 21.
- Schwarzer R, Luszczynska A. Health action process approach. In: Norman P, Conner M, editors. Predicting and changing health behavior. Maidenead, UK: McGraw-Hill; 2015.
- Sallis JF, Spoon C, Cavill N, Engelberg JK, Gebel K, Parker M, Thornton CM, Lou D, Wilson AL, Cutter CL, Ding D. Co-benefits of designing communities for active living: an exploration of literature. Int J Behav Nutr Phys Act. 2015 Feb 28;12:30. doi: 10.1186/s12966-015-0188-2.
- Maher JP, Conroy DE. A dual-process model of older adults' sedentary behavior. Health Psychol. 2016 Mar;35(3):262-72. doi: 10.1037/hea0000300. Epub 2015 Dec 21.
- Keller C, Siegrist M. The weight management strategies inventory (WMSI). Development of a new measurement instrument, construct validation, and association with dieting success. Appetite. 2015 Sep;92:322-36. doi: 10.1016/j.appet.2015.05.037. Epub 2015 Jun 3.
- Berli C, Loretini P, Radtke T, Hornung R, Scholz U. Predicting physical activity in adolescents: the role of compensatory health beliefs within the Health Action Process Approach. Psychol Health. 2014;29(4):458-74. doi: 10.1080/08870446.2013.865028. Epub 2013 Dec 20.
- Luszczynska A, Hagger MS, Banik A, Horodyska K, Knoll N, Scholz U. Self-Efficacy, Planning, or a Combination of Both? A Longitudinal Experimental Study Comparing Effects of Three Interventions on Adolescents' Body Fat. PLoS One. 2016 Jul 13;11(7):e0159125. doi: 10.1371/journal.pone.0159125. eCollection 2016.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- USSHWarsaw
- 2017/27/B/HS6/00092 (Other Grant/Funding Number: National Science Centre, Poland)
- 2021/43/O/HS6/00712/ (Other Grant/Funding Number: National Science Centre, Poland)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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