Health BehaviorNCT02713438
Effects of Individual, Dyadic, and Collaborative Plans on Physical Activity in Parent-Child Dyads
A study testing Individual Planning, Dyadic Planning and Collaborative Planning in people with Health Behavior, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
Trial summary
AIMS: The project aims at investigating of the effects of three types of planning (individual planning, collaborative planning, and dyadic planning) on physical activity.The influence of three planning interventions are compared with an active control condition, including physical activity education. Read more about this study
- Who is it for?
- Ages 10 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Individual Planning, Dyadic Planning and Collaborative Planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2016to Dec 2023
- 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 10 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy children (age 10-14) and one healthy parents (any gender) or legal guardians
- Child or parent/legal guardian with chronic conditions but without contraindications for moderate intensity physical activity
Who cannot join
- Children younger than 10 years old
- Parents who declared plans for changing residence during the following year (e.g., due to moving to another region of the country)
- No parental consent at the baseline
- No child consent at the baseline
- Existing diseases with contraindications for moderate intensity physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity, and Health-Related Quality of Life: Dyadic Research in the Context of Forming Individual, Dyadic, and Collaborative Plans (Trial 1: Parent-Child Dyads)
AIMS: The project aims at investigating of the effects of three types of planning (individual planning, collaborative planning, and dyadic planning) on physical activity.The influence of three planning interventions are compared with an active control condition, including physical activity education.
PARTICIPANTS: The effects of the interventions are evaluated among parent-child (aged 10-14) dyads, with a minimum of 50 dyads enrolled into the each arm of the trial (a total of 200 dyads). The interventions consist of six planning sessions.
Read more
DESIGN: The dyads are randomly assigned to one of four experimental conditions. The assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after the first intervention session, at post-intervention (after six intervention sessions are completed), and at 6-, and 12-month follow-ups.
OUTCOMES: Physical activity constitutes the main outcome, whereas health-related quality of life (HRQOL), body mass index, as well as the self-regulatory strategy called the use of planning (individual, dyadic and collaborative) are secondary outcomes.
Read the detailed description
Individual planning (also known as implementation intentions or action and coping planning) is a regulatory strategy, which refers to making plans on when, where, and how to perform an intended behavior. In dyadic planning, a target person is setting plans together with a partner on when, where, and how the target person will individually engage in behavior change. The concept of dyadic planning differs from the conceptualization of collaborative plans, where two individuals make plans on how to enact a behavior together.
The study will evaluate the effects of a short-term planning intervention. The intervention includes a total of six sessions: two face-to-face sessions with the experimenter (delivered over two weeks) and three sessions delivered over phone (over the following three weeks), one face-two-face session (delivered at one month after the third session delivered over the phone). The delivery has an individual format (the experimenter + the dyad). The total time from first to sixth session is 2 months. The setting for the interventions will include schools (school nurse office) or/and participant's home. The same format, schedule, delivery, and setting will be used for conducting active control group procedures.
- Conditions
- Health Behavior
- Being tested
- Individual Planning, Dyadic Planning, Collaborative Planning, Education
- Keywords
- Physical activity, Planning, Implementation intention, Quality of life, Body weight
- Medical subject headings
- Health Behavior, Motor Activity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual PlanningBehavioural
CONTENT: The planning materials and forms have sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) 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, risky situations or temptations to not engage in physical activity).
Each participant forms their plans individually, without consulting the dyadic partner, but discussing the plans with the experimenter.
Dyadic PlanningBehavioural
CONTENT: The planning materials and forms have sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) 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, risky situations or temptations to not engage in physical activity).
Both partners in the dyad jointly form one plan. This jointly developed plan is discussed with the experimenter. The plan focuses on physical activity of only one person in the dyad: the child (parent-child dyads).
Collaborative PlanningBehavioural
CONTENT: The planning materials and forms have sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) 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, risky situations or temptations to not engage in physical activity).
Both partners in the dyad jointly form one plan. This jointly developed plan is discussed with the experimenter. The plan focuses on physical activity of both persons within the dyad (parent and child) and include some plans for joint physical activity.
EducationBehavioural
CONTENT: The education materials address physical activity and healthy nutrition guidelines for age groups. Participants receive a set of educational materials about types of physical activity (PA), PA intensity, exercise calorie expenditure, strength and endurance training, stretching, and general nutrition guidelines in terms of meal composition, and nutrients, meal frequency. The materials exclude any planning statements.
The education is delivered by the experimenter to a parent-child dyad and discusses individual guidelines for both dyadic partners.
| Study group | Role | What they receive |
|---|---|---|
| Individual Planning | Experimental | Participants are filling in the planning forms, referring to their individual physical activity. Both members of the dyad form their own, interdependent plans.
The following behavior change techniques (BCT) are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning. Receives: Behavioral: Individual Planning; Behavioral: Education |
| Dyadic Planning | Experimental | Participants are filling in the planning forms jointly. Planning refers to physical activity of only one person in the dyad, the child. The parent is actively participating in forming plans by the child.
The following BCT are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning. Receives: Behavioral: Dyadic Planning; Behavioral: Education |
| Collaborative Planning | Experimental | Participants are filling in the planning forms jointly. Planning refers to physical activity of both persons in the dyad (child and parent). Physical activity may be performed jointly by both persons in the dyad.
The following BCT are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning. Receives: Behavioral: Collaborative Planning; Behavioral: Education |
| Education | Active comparator | The education group received extended physical activity and healthy nutrition education program. The education includes: (1) the guidelines for physical activity and healthy nutrition, tailored to age and health status of the participant, (2) the examples of exercises and their metabolic equivalent; (3) information about healthy body mass and body composition. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Accelerometry: ActiGraph (the model: wGT3X-B)
Measured: Change from the baseline physical activity at 8 months
Secondary outcomes (6)
Health-related quality of life (HRQOOL)
WHOQOL-BREF (Skevington et al., 2004), the measure HRQOL among adults (parents)
Measured: Change from baseline HRQOL at 8 months
Health-related quality of life (HRQOL)
KIDSCREEN-10 (Ravens-Sieberer et al., 2010); the measure HRQOL among children
Measured: Change from baseline HRQOL at 8 months
The use of planning
The self-reported use of planning (individual, dyadic and collaborative) questionnaire, based on Luszczynska (2006)
Measured: Change from baseline use of planning at 2 months
Body mass index (BMI)
Certified and standardized body weight scales (Beurer; European Union safety certificate; measurement error < 5%) and measuring rods will be used. BMI will be calculated as body weight (in kilograms) divided by a square height (in meters)
Measured: Change from baseline BMI at 8 months
Physical activity behavior
The International Physical Activity Questionnaire (IPAQ) (Craig et al., 2003); open-ended questions indicating the minutes and the number of occasions of physical activity behavior per week; higher scores represent better outcome
Measured: Baseline (before the intervention) to 1 week after the first face-to face intervention session); Baseline to 6-month follow-up
Sedentary behavior
Accelerometry: ActiGraph (the model: wGT3X-B)
Measured: Baseline (before the intervention) to 1 week after the first face-to face intervention session); Baseline to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Health 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Sciences and Humanities, Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksandra Luszczynska, PhD, Principal investigator, SWPS University of Social Sciences and Humanities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713438
- Sponsor's protocol ID
- 2014/15/B/HS6/00923_PCD
- Other IDs
- 2014/15/B/HS6/00923
- Status last verified
- Dec 2023
- First submitted
- 10 Mar 2016
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be made publicly available in 3 years after the completion of the trial
Publications
Burkert S, Knoll N, Luszczynska A, Gralla O. The interplay of dyadic and individual planning of pelvic-floor exercise in prostate-cancer patients following radical prostatectomy. J Behav Med. 2012 Jun;35(3):305-17. doi: 10.1007/s10865-012-9416-2. Epub 2012 Mar 28.
PubMed 22454228Prestwich A, Conner MT, Lawton RJ, Ward JK, Ayres K, McEachan RR. Randomized controlled trial of collaborative implementation intentions targeting working adults' physical activity. Health Psychol. 2012 Jul;31(4):486-95. doi: 10.1037/a0027672. Epub 2012 Apr 2.
PubMed 22468716Luszczynska A. An implementation intentions intervention, the use of a planning strategy, and physical activity after myocardial infarction. Soc Sci Med. 2006 Feb;62(4):900-8. doi: 10.1016/j.socscimed.2005.06.043. Epub 2005 Aug 10.
PubMed 16095786Ravens-Sieberer U, Erhart M, Rajmil L, Herdman M, Auquier P, Bruil J, Power M, Duer W, Abel T, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J; European KIDSCREEN Group. Reliability, construct and criterion validity of the KIDSCREEN-10 score: a short measure for children and adolescents' well-being and health-related quality of life. Qual Life Res. 2010 Dec;19(10):1487-500. doi: 10.1007/s11136-010-9706-5. Epub 2010 Jul 30.
PubMed 20668950Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
PubMed 15085902Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Hagger MS, Luszczynska A. Implementation intention and action planning interventions in health contexts: state of the research and proposals for the way forward. Appl Psychol Health Well Being. 2014 Mar;6(1):1-47. doi: 10.1111/aphw.12017. Epub 2013 Oct 8.
PubMed 24591064Sniehotta FF, Scholz U, Schwarzer R. Action plans and coping plans for physical exercise: A longitudinal intervention study in cardiac rehabilitation. Br J Health Psychol. 2006 Feb;11(Pt 1):23-37. doi: 10.1348/135910705X43804.
PubMed 16480553Burkert S, Scholz U, Gralla O, Roigas J, Knoll N. Dyadic planning of health-behavior change after prostatectomy: a randomized-controlled planning intervention. Soc Sci Med. 2011 Sep;73(5):783-92. doi: 10.1016/j.socscimed.2011.06.016. Epub 2011 Jul 12.
PubMed 21807446
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, and Health-Related Quality of Life: Dyadic Research in the Context of Forming Individual, Dyadic, and Collaborative Plans (Trial 1: Parent-Child Dyads)
- ClinicalTrials.gov ID
- NCT02713438
- Acronym / sponsor ID
- 2014/15/B/HS6/00923_PCD
- Conditions
- Health Behavior
- Keywords
- Physical activity, Planning, Implementation intention, Quality of life, Body weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- University of Social Sciences and Humanities, WarsawUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Nov 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 18 Mar 2016 (estimated)
- 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.
AIMS: The project aims at investigating of the effects of three types of planning (individual planning, collaborative planning, and dyadic planning) on physical activity.The influence of three planning interventions are compared with an active control condition, including physical activity education.
PARTICIPANTS: The effects of the interventions are evaluated among parent-child (aged 10-14) dyads, with a minimum of 50 dyads enrolled into the each arm of the trial (a total of 200 dyads). The interventions consist of six planning sessions.
DESIGN: The dyads are randomly assigned to one of four experimental conditions. The assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after the first intervention session, at post-intervention (after six intervention sessions are completed), and at 6-, and 12-month follow-ups.
OUTCOMES: Physical activity constitutes the main outcome, whereas health-related quality of life (HRQOL), body mass index, as well as the self-regulatory strategy called the use of planning (individual, dyadic and collaborative) are secondary outcomes.
Detailed description
Individual planning (also known as implementation intentions or action and coping planning) is a regulatory strategy, which refers to making plans on when, where, and how to perform an intended behavior. In dyadic planning, a target person is setting plans together with a partner on when, where, and how the target person will individually engage in behavior change. The concept of dyadic planning differs from the conceptualization of collaborative plans, where two individuals make plans on how to enact a behavior together.
The study will evaluate the effects of a short-term planning intervention. The intervention includes a total of six sessions: two face-to-face sessions with the experimenter (delivered over two weeks) and three sessions delivered over phone (over the following three weeks), one face-two-face session (delivered at one month after the third session delivered over the phone). The delivery has an individual format (the experimenter + the dyad). The total time from first to sixth session is 2 months. The setting for the interventions will include schools (school nurse office) or/and participant's home. The same format, schedule, delivery, and setting will be used for conducting active control group procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Individual Planning | Experimental | Behavioral: Individual Planning, Behavioral: EducationParticipants are filling in the planning forms, referring to their individual physical activity. Both members of the dyad form their own, interdependent plans. The following behavior change techniques (BCT) are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning. |
| Dyadic Planning | Experimental | Behavioral: Dyadic Planning, Behavioral: EducationParticipants are filling in the planning forms jointly. Planning refers to physical activity of only one person in the dyad, the child. The parent is actively participating in forming plans by the child. The following BCT are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning. |
| Collaborative Planning | Experimental | Behavioral: Collaborative Planning, Behavioral: EducationParticipants are filling in the planning forms jointly. Planning refers to physical activity of both persons in the dyad (child and parent). Physical activity may be performed jointly by both persons in the dyad. The following BCT are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning. |
| Education | Active comparator | Behavioral: EducationThe education group received extended physical activity and healthy nutrition education program. The education includes: (1) the guidelines for physical activity and healthy nutrition, tailored to age and health status of the participant, (2) the examples of exercises and their metabolic equivalent; (3) information about healthy body mass and body composition. |
Who may qualify
- Ages
- 10 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy children (age 10-14) and one healthy parents (any gender) or legal guardians
- Child or parent/legal guardian with chronic conditions but without contraindications for moderate intensity physical activity
Key exclusion criteria (5 listed)
- Children younger than 10 years old
- Parents who declared plans for changing residence during the following year (e.g., due to moving to another region of the country)
- No parental consent at the baseline
- No child consent at the baseline
- Existing diseases with contraindications for moderate intensity physical activity
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 |
|---|---|---|
| Individual PlanningCONTENT: The planning materials and forms have sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) 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, risky situations or temptations to not engage in physical activity). Each participant forms their plans individually, without consulting the dyadic partner, but discussing the plans with the experimenter. | Behavioural | Individual Planning |
| Dyadic PlanningCONTENT: The planning materials and forms have sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) 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, risky situations or temptations to not engage in physical activity). Both partners in the dyad jointly form one plan. This jointly developed plan is discussed with the experimenter. The plan focuses on physical activity of only one person in the dyad: the child (parent-child dyads). | Behavioural | Dyadic Planning |
| Collaborative PlanningCONTENT: The planning materials and forms have sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) 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, risky situations or temptations to not engage in physical activity). Both partners in the dyad jointly form one plan. This jointly developed plan is discussed with the experimenter. The plan focuses on physical activity of both persons within the dyad (parent and child) and include some plans for joint physical activity. | Behavioural | Collaborative Planning |
| EducationCONTENT: The education materials address physical activity and healthy nutrition guidelines for age groups. Participants receive a set of educational materials about types of physical activity (PA), PA intensity, exercise calorie expenditure, strength and endurance training, stretching, and general nutrition guidelines in terms of meal composition, and nutrients, meal frequency. The materials exclude any planning statements. The education is delivered by the experimenter to a parent-child dyad and discusses individual guidelines for both dyadic partners. | Behavioural | Collaborative Planning, Dyadic Planning, Education, Individual Planning |
Primary outcome
Physical activity
Time frame: Change from the baseline physical activity at 8 months
Accelerometry: ActiGraph (the model: wGT3X-B)
6 secondary outcomes
Health-related quality of life (HRQOOL)
Time frame: Change from baseline HRQOL at 8 months
Health-related quality of life (HRQOL)
Time frame: Change from baseline HRQOL at 8 months
The use of planning
Time frame: Change from baseline use of planning at 2 months
Body mass index (BMI)
Time frame: Change from baseline BMI at 8 months
Physical activity behavior
Time frame: Baseline (before the intervention) to 1 week after the first face-to face intervention session); Baseline to 6-month follow-up
Sedentary behavior
Time frame: Baseline (before the intervention) to 1 week after the first face-to face intervention session); Baseline to 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Background: PubMed 22454228Burkert S, Knoll N, Luszczynska A, Gralla O. The interplay of dyadic and individual planning of pelvic-floor exercise in prostate-cancer patients following radical prostatectomy. J Behav Med. 2012 Jun;35(3):305-17. doi: 10.1007/s10865-012-9416-2. Epub 2012 Mar 28.
- Background: PubMed 22468716Prestwich A, Conner MT, Lawton RJ, Ward JK, Ayres K, McEachan RR. Randomized controlled trial of collaborative implementation intentions targeting working adults' physical activity. Health Psychol. 2012 Jul;31(4):486-95. doi: 10.1037/a0027672. Epub 2012 Apr 2.
- Background: PubMed 16095786Luszczynska A. An implementation intentions intervention, the use of a planning strategy, and physical activity after myocardial infarction. Soc Sci Med. 2006 Feb;62(4):900-8. doi: 10.1016/j.socscimed.2005.06.043. Epub 2005 Aug 10.
- Background: PubMed 20668950Ravens-Sieberer U, Erhart M, Rajmil L, Herdman M, Auquier P, Bruil J, Power M, Duer W, Abel T, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J; European KIDSCREEN Group. Reliability, construct and criterion validity of the KIDSCREEN-10 score: a short measure for children and adolescents' well-being and health-related quality of life. Qual Life Res. 2010 Dec;19(10):1487-500. doi: 10.1007/s11136-010-9706-5. Epub 2010 Jul 30.
- Background: PubMed 15085902Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 24591064Hagger MS, Luszczynska A. Implementation intention and action planning interventions in health contexts: state of the research and proposals for the way forward. Appl Psychol Health Well Being. 2014 Mar;6(1):1-47. doi: 10.1111/aphw.12017. Epub 2013 Oct 8.
- Background: PubMed 16480553Sniehotta FF, Scholz U, Schwarzer R. Action plans and coping plans for physical exercise: A longitudinal intervention study in cardiac rehabilitation. Br J Health Psychol. 2006 Feb;11(Pt 1):23-37. doi: 10.1348/135910705X43804.
- Background: PubMed 21807446Burkert S, Scholz U, Gralla O, Roigas J, Knoll N. Dyadic planning of health-behavior change after prostatectomy: a randomized-controlled planning intervention. Soc Sci Med. 2011 Sep;73(5):783-92. doi: 10.1016/j.socscimed.2011.06.016. Epub 2011 Jul 12.
- Individual participant dataSharing planned: Yes. Data will be made publicly available in 3 years after the completion of the trial
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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 Individual Planning, Dyadic Planning and Collaborative Planning in people with Health 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 14 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: Change from the baseline physical activity 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 NCT02713438, which also lists 9 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 14 Dec 2023.