- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03011385
Effects of Individual, Dyadic, and Collaborative Plans on Physical Activity in Partner-Partner Dyads
Physical Activity and Health-related Quality of Life: Dyadic Research in the Context of Forming Individual, Dyadic, and Collaborative Plans. Trial 3
OBJECTIVE: The project aims at investigating of the effects of three types of planning (individual planning, collaborative planning, and dyadic planning) on physical activity among dyads.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 dyads of two adults (partner-partner dyads). Adults forming dyads (e.g. two romantic partners, two relatives, two co-workers, two friends) who are in regular contact for at least one year will be enrolled. 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, and sedentary behavior as well as the self-regulatory strategy called the use of planning (individual, dyadic and collaborative) are secondary outcomes.
Study Overview
Status
Conditions
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 physician's offices and participant's home. The same format, schedule, delivery, and setting will be used for conducting active control group procedures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wroclaw, Poland, 53-238
- University of Social Sciences and Humanities
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both partners in the dyad are adults
- At least one partner in the dyad does not meet the World Health Organization guidelines for physical activity for their respective age group and health status
- Participants are healthy or with a diagnosed chronic illness (without contraindications for moderate intensity physical activity
- The partners may be a romantic relationship or in another relationship: next of kin, family members, friends who are willing to join the study together
- The dyadic partners are in the stable relationship for at least one year or meet and spend time together regularly for at least one year
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
- Both participants in the dyad meet the World Health Organization guidelines for physical activity for their respective age group and health status in terms of minutes per week, the intensity of physical activity, and the types of exercises
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: Individual Planning
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) will be formed. Each participant will form their plans individually, without consulting the dyadic partner, but discussing the plans with the experimenter. |
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.
The education group participants receive 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 participants, (2) the examples of exercises and their metabolic equivalent; (3) information about healthy body mass and body composition.
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Experimental: Dyadic Planning
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 as well as coping plans will be formed. 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. This target person will be selected jointly by the participants if both participants are healthy. If one participant has a chronic disease, e.g. diabetes or a cardiovascular disease, the plans are formed for the person with a disease. |
The education group participants receive 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 participants, (2) the examples of exercises and their metabolic equivalent; (3) information about healthy body mass and body composition.
Participants are filling in the planning forms jointly. Planning refers to physical activity of only one person in the dyad. The other person in the dyad is actively participating in forming plans by the target person. 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. |
Experimental: Collaborative Planning
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 and coping plans will be formed. 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 (both partners) and include some plans for joint physical activity. |
The education group participants receive 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 participants, (2) the examples of exercises and their metabolic equivalent; (3) information about healthy body mass and body composition.
Participants are filling in the planning forms jointly.
Planning refers to physical activity of both persons in the dyad.
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.
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Active Comparator: Education
The education materials address physical activity and healthy nutrition guidelines for age groups and chronic disease.
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 partner-partner dyad and discusses individual guidelines for both dyadic partners.
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The education group participants receive 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 participants, (2) the examples of exercises and their metabolic equivalent; (3) information about healthy body mass and body composition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity
Time Frame: Change from baseline physical activity at 8 months
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Accelerometry: ActiGraph (the model: wGT3X-B)
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Change from baseline physical activity at 8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The use of planning
Time Frame: Change from baseline use of planning at 2 months
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The self-reported use of planning questionnaire (individual, dyadic and collaborative), based on Luszczynska (2006)
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Change from baseline use of planning at 2 months
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Body mass index (BMI)
Time Frame: Change from baseline BMI 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 baseline BMI at 8 months
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Health-related quality of life (HRQOL)
Time Frame: Change from baseline HRQOL at 8 months
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WHOQOL--BREF Questionnaire (Skevington et al., 2004)
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Change from baseline HRQOL at 8 months
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Physical activity
Time Frame: Change from the baseline physical activity at 8 months
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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
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Change from the baseline physical activity at 8 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Habitual physical activity
Time Frame: Change from baseline habitual physical activity at 8 months
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Self-reported habit index questionnaire for physical activity (based on Gardner et al., 2012)
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Change from baseline habitual physical activity at 8 months
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Habitual sedentary behavior
Time Frame: Change from baseline habitual sedentary behavior at 8 months
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Self-reported habit index questionnaire for sedentary behavior (based on Gardner et al., 2012)
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Change from baseline habitual sedentary behavior at 8 months
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Sedentary behavior
Time Frame: Change from baseline habitual sedentary behavior at 8 months
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Accelerometry: ActiGraph (the model: wGT3X-B)
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Change from baseline habitual sedentary behavior at 8 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Aleksandra Luszczynska, PhD, SWPS University of Social Sciences and Humanities
Publications and helpful links
General Publications
- Craig 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.
- Hagger 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.
- Skevington 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.
- 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.
- Prestwich 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.
- Luszczynska 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.
- Sniehotta 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.
- Burkert 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.
- Kulis E, Szczuka Z, Keller J, Banik A, Boberska M, Kruk M, Knoll N, Radtke T, Scholz U, Rhodes RE, Luszczynska A. Collaborative, dyadic, and individual planning and physical activity: A dyadic randomized controlled trial. Health Psychol. 2022 Feb;41(2):134-144. doi: 10.1037/hea0001124. Epub 2021 Dec 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2014/15/B/HS6/00923_C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Study Protocol
Information comments: The file includes the protocol for data collection and intervention sessions
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