Sedentary BehaviorNCT04131270
Explaining Sedentary Behavior With Planning (the Revised HAPA Model)
A study testing Planning + Education and Education in people with Sedentary Behavior, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
Trial summary
This study would investigate the effects of forming action plans on a reduction of sedentary behaviors. Participants will be randomly assigned to either active control group (education on sedentary behaviors and physical activity) or the intervention group (forming action plans referring to replacing sedentary… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Planning + Education and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jan 2020to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- not meeting physical activity guidelines proposed by the World Health Organization
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
SWPS University of Social Sciences and Humanities
Wroclaw, Lower Silezia, 53-328
Katarzyna Byrka, PhD, kbyrka@swps.edu.pl
Martyna Kuszneruk, MA, mkuszneruk@swps.edu.pl
About this study
Official title: Explaining Sedentary Behavior With the Revised Reflective + Impulsive Health Action Process Approach (HAPA) Model
This study would investigate the effects of forming action plans on a reduction of sedentary behaviors. Participants will be randomly assigned to either active control group (education on sedentary behaviors and physical activity) or the intervention group (forming action plans referring to replacing sedentary activities with physical activity. The effects of the intervention will be evaluated at the 2-month follow-up and at the 8-month follow-up.
Read the 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.
- Conditions
- Sedentary Behavior
- Being tested
- Planning + Education, Education
- Keywords
- Planning, Physical Activity
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planning + EducationBehavioural
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.
EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Planning + Education | Experimental | 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. Receives: Behavioral: Planning + Education; Behavioral: Education |
| Education | Active comparator | 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. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary behavior
minutes of sedentary behavior per day assessed with ActiGraph wGT3X-BT accelerometer
Measured: change from the baseline sedentary behavior at 8 months
Secondary outcomes (2)
The composition of waking time
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
Measured: change from the baseline composition of waking time at 8 months
Physical activity
minutes of light, moderate and vigorous intensity physical activity per day measured with ActiGraph wGT3X-BT accelerometer
Measured: change from the baseline physical activity at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start2 Jan 2020
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to an active control group (education on sedentary behavior and physical activity) or to a planning intervention (education on sedentary behavior and physical activity + education on how to form behavior change plans + forming a plan to change sedentary behavior using a planning sheet)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Social Sciences and Humanities, Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Centre, Poland
- Responsible party
- Principal investigator, Aleksandra Luszczynska, University of Social Sciences and Humanities, Warsaw
- Investigators
- Aleksandra Luszczynska, PhD, Principal investigator, SWPS University of Social Sciences and Humanities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131270
- Sponsor's protocol ID
- USSHWarsaw
- Other IDs
- 2017/27/B/HS6/00092, 2021/43/O/HS6/00712/
- Status last verified
- Mar 2024
- First submitted
- 15 Oct 2019
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary, secondary, and additional outcome measures will be made available.
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.
PubMed 25207647Schwarzer 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.
PubMed 25886356Maher 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.
PubMed 26690644Keller 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.
PubMed 26048006Berli 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.
PubMed 24229317Luszczynska 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.
PubMed 27410961Krzywicka P, Kulis E, Szczuka Z, Siwa M, Banik A, Wietrzykowska D, Kornafel A, Zaleskiewicz H, Misiakowska J, Boberska M, Knoll N, Radtke T, Luszczynska A. Adding planning strategies to an experiential and conceptual knowledge-based intervention: Does it help to reduce sedentary time? Psychol Sport Exerc. 2025 Mar;77:102782. doi: 10.1016/j.psychsport.2024.102782. Epub 2024 Nov 20.
PubMed 39577821
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explaining Sedentary Behavior With the Revised Reflective + Impulsive Health Action Process Approach (HAPA) Model
- ClinicalTrials.gov ID
- NCT04131270
- Acronym / sponsor ID
- USSHWarsaw
- Conditions
- Sedentary Behavior
- Keywords
- Planning, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of Social Sciences and Humanities, WarsawUniversity, hospital or other
- Collaborators
- National Science Centre, Poland
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study would investigate the effects of forming action plans on a reduction of sedentary behaviors. Participants will be randomly assigned to either active control group (education on sedentary behaviors and physical activity) or the intervention group (forming action plans referring to replacing sedentary activities with physical activity. The effects of the intervention will be evaluated at the 2-month follow-up and at the 8-month follow-up.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to an active control group (education on sedentary behavior and physical activity) or to a planning intervention (education on sedentary behavior and physical activity + education on how to form behavior change plans + forming a plan to change sedentary behavior using a planning sheet)
| Arm | Type | Receives |
|---|---|---|
| Planning + Education | Experimental | Behavioral: Planning + Education, Behavioral: Education3 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. |
| Education | Active comparator | Behavioral: Education3 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- not meeting physical activity guidelines proposed by the World Health Organization
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Planning + EducationPlanning: 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. | Behavioural | Planning + Education |
| EducationThe 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. | Behavioural | Education, Planning + Education |
Primary outcome
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
2 secondary outcomes
The composition of waking time
Time frame: change from the baseline composition of waking time at 8 months
Physical activity
Time frame: change from the baseline physical activity at 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Background: PubMed 25207647Gardner 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.
- BackgroundSchwarzer R, Luszczynska A. Health action process approach. In: Norman P, Conner M, editors. Predicting and changing health behavior. Maidenead, UK: McGraw-Hill; 2015.
- Background: PubMed 25886356Sallis 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.
- Background: PubMed 26690644Maher 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.
- Background: PubMed 26048006Keller 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.
- Background: PubMed 24229317Berli 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.
- Background: PubMed 27410961Luszczynska 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.
- Derived from this study: PubMed 39577821Krzywicka P, Kulis E, Szczuka Z, Siwa M, Banik A, Wietrzykowska D, Kornafel A, Zaleskiewicz H, Misiakowska J, Boberska M, Knoll N, Radtke T, Luszczynska A. Adding planning strategies to an experiential and conceptual knowledge-based intervention: Does it help to reduce sedentary time? Psychol Sport Exerc. 2025 Mar;77:102782. doi: 10.1016/j.psychsport.2024.102782. Epub 2024 Nov 20.
- Study protocol in PolishLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary, secondary, and additional outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Luszczynska, PhD principal investigator
SWPS University of Social Sciences and Humanities
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planning + Education and Education in people with Sedentary Behavior, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksandra Luszczynska, PhD (+48694441765, aluszczynska@swps.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedentary behavior (time frame: change from the baseline sedentary behavior at 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04131270, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.