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

Not Applicable
Withdrawn
Conditions
Health Behavior
Interventions
Behavioral: Individual Planning
Behavioral: Dyadic Planning
Behavioral: Collaborative Planning
Behavioral: Education
Registration Number
NCT02712255
Lead Sponsor
University of Social Sciences and Humanities, Warsaw
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Individual PlanningEducationParticipants 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.
Collaborative PlanningEducationParticipants are filling in the planning forms jointly. Planning refers to physical activity of both persons in the dyad (the patient and the partner). 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.
Individual PlanningIndividual PlanningParticipants 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 PlanningDyadic PlanningParticipants are filling in the planning forms jointly. Planning refers to physical activity of only one person in the dyad, the patient. The partner is actively participating in forming plans by the patient. 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
EducationEducationThe 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 participant, (2) the examples of exercises and their metabolic equivalent; (3) information about healthy body mass and body composition.
Dyadic PlanningEducationParticipants are filling in the planning forms jointly. Planning refers to physical activity of only one person in the dyad, the patient. The partner is actively participating in forming plans by the patient. 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 PlanningCollaborative PlanningParticipants are filling in the planning forms jointly. Planning refers to physical activity of both persons in the dyad (the patient and the partner). 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.
Primary Outcome Measures
NameTimeMethod
Physical activityChange from the baseline physical activity at 8 months

The International Physical Activity Questionnaire (IPAQ) (Craig et al., 2003)

Secondary Outcome Measures
NameTimeMethod
The use of planningChange from baseline use of planning at 2 months

The self-reported use of planning questionnaire (individual, dyadic and collaborative), based on Luszczynska (2006)

Body mass index (BMI)Change from baseline BMI at 8 months

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.

Health-related quality of life (HRQOL)Change from baseline HRQOL at 8 months

WHOQOL-BREF (Skevington et al., 2004)

Physical activityChange from baseline physical activity at 8 months

Accelerometry: ActiGraph (model wGT3X-B)

Trial Locations

Locations (1)

University of Social Sciences and Humanities

🇵🇱

Warsaw, Poland

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