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

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

Interventional

Enrollment (Actual)

640

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Wroclaw, Poland, 53-238
        • University of Social Sciences and Humanities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.
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.

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
Accelerometry: ActiGraph (the model: wGT3X-B)
Change from baseline physical activity at 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The use of planning
Time Frame: Change from baseline use of planning at 2 months
The self-reported use of planning questionnaire (individual, dyadic and collaborative), based on Luszczynska (2006)
Change from baseline use of planning at 2 months
Body mass index (BMI)
Time Frame: 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.
Change from baseline BMI at 8 months
Health-related quality of life (HRQOL)
Time Frame: Change from baseline HRQOL at 8 months
WHOQOL--BREF Questionnaire (Skevington et al., 2004)
Change from baseline HRQOL at 8 months
Physical activity
Time Frame: Change from the baseline physical activity at 8 months
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
Change from the baseline physical activity at 8 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Habitual physical activity
Time Frame: Change from baseline habitual physical activity at 8 months
Self-reported habit index questionnaire for physical activity (based on Gardner et al., 2012)
Change from baseline habitual physical activity at 8 months
Habitual sedentary behavior
Time Frame: Change from baseline habitual sedentary behavior at 8 months
Self-reported habit index questionnaire for sedentary behavior (based on Gardner et al., 2012)
Change from baseline habitual sedentary behavior at 8 months
Sedentary behavior
Time Frame: Change from baseline habitual sedentary behavior at 8 months
Accelerometry: ActiGraph (the model: wGT3X-B)
Change from baseline habitual sedentary behavior at 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aleksandra Luszczynska, PhD, SWPS University of Social Sciences and Humanities

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

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)?

YES

IPD Plan Description

As agreed with the funding institution (the National Science Centre, Poland) the dataset will be publicly available (for research use) not later than in 2023 at the website of the SWPS University of Social Sciences and Humanities, Wroclaw, Poland

Study Data/Documents

  1. Study Protocol
    Information comments: The file includes the protocol for data collection and intervention sessions

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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