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Completed

NCT Number: NCT03011385

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

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.

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Key information

Conditions

Health Behavior Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Social Sciences and Humanities

Wroclaw, 53-238, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individual Planning

Behavioral

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.

Dyadic Planning

Behavioral

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.

Collaborative Planning

Behavioral

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.

Education

Behavioral

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.

Primary outcomes

  1. Physical activity

    Time frame: Change from baseline physical activity at 8 months

    Accelerometry: ActiGraph (the model: wGT3X-B)

Secondary outcomes

  1. Health-related quality of life (HRQOL)

    Time frame: Change from baseline HRQOL at 8 months

    WHOQOL--BREF Questionnaire (Skevington et al., 2004)

  2. 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)

  3. 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.

  4. 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

Other outcomes

  1. 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)

  2. 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)

  3. Sedentary behavior

    Time frame: Change from baseline habitual sedentary behavior at 8 months

    Accelerometry: ActiGraph (the model: wGT3X-B)

Sponsors and collaborators

Lead sponsor

University of Social Sciences and Humanities, Warsaw

Other

Registry information

Official study title

Physical Activity and Health-related Quality of Life: Dyadic Research in the Context of Forming Individual, Dyadic, and Collaborative Plans. Trial 3

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Jan 5, 2017
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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