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Effects of Individual, Dyadic, and Collaborative Plans on Physical Activity in Patient-Partner Dyads

Physical Activity, and Health-Related Quality of Life: Dyadic Research in the Context of Forming Individual, Dyadic, and Collaborative Plans (Trial 2: Patient-Partner Dyads)

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02712255
Enrollment
0
Registered
2016-03-18
Start date
2016-03-31
Completion date
2023-07-31
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

Keywords

Physical activity, Quality of life, Planning, Implementation intentions, Cardiovascular disease, Diabetes

Brief summary

THE 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 dyads of patient and his/her partner. The patients with physical activity-related chronic diseases (cerebrovascular diseases or diabetes) 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, 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 physician's offices and participant's home. The same format, schedule, delivery, and setting will be used for conducting active control group procedures.

Interventions

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 will form their plans individually, without consulting the dyadic partner, but discussing the plans with the experimenter.

BEHAVIORALDyadic Planning

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 patient.

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 (the patient and the partner) and include some plans for joint physical activity.

BEHAVIORALEducation

CONTENT: 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 patient-partner dyad and discusses individual guidelines for both dyadic partners.

Sponsors

University of Social Sciences and Humanities, Warsaw
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* One person in the dyad (defined as the patient) has (1) a cardiovascular disease (any type) with recommended physical activity change or (2) diabetes (any type) with recommended physical activity change * The other person in the dyad (defined as the partner) is healthy or has a chronic condition without contraindications for moderate intensity physical activity * The partner may be a romantic partner, a next of kin, a family member, or a friend who is willing to join the study together with the patient * The patient and partner 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 * Participants who meet the 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

Design outcomes

Primary

MeasureTime frameDescription
Physical activityChange from the baseline physical activity at 8 monthsThe International Physical Activity Questionnaire (IPAQ) (Craig et al., 2003)

Secondary

MeasureTime frameDescription
Health-related quality of life (HRQOL)Change from baseline HRQOL at 8 monthsWHOQOL-BREF (Skevington et al., 2004)
The use of planningChange from baseline use of planning at 2 monthsThe self-reported use of planning questionnaire (individual, dyadic and collaborative), based on Luszczynska (2006)
Body mass index (BMI)Change from baseline BMI at 8 monthsCertified 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.
Physical activityChange from baseline physical activity at 8 monthsAccelerometry: ActiGraph (model wGT3X-B)

Other

MeasureTime frameDescription
Habitual physical activityChange from baseline habitual physical activity at 8 monthsSelf-reported habit index questionnaire for physical activity (Gardner et al., 2012)
Habitual sedentary behaviorChange from baseline habitual sedentary behavior at 8 monthsSelf-reported habit index questionnaire for sedentary behavior (Gardner et al., 2012)

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026