NCT03011385

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

3.2 years

First QC Date

January 3, 2017

Last Update Submit

May 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    Accelerometry: ActiGraph (the model: wGT3X-B)

    Change from baseline physical activity at 8 months

Secondary Outcomes (4)

  • Health-related quality of life (HRQOL)

    Change from baseline HRQOL at 8 months

  • The use of planning

    Change from baseline use of planning at 2 months

  • Body mass index (BMI)

    Change from baseline BMI at 8 months

  • Physical activity

    Change from the baseline physical activity at 8 months

Other Outcomes (3)

  • Habitual physical activity

    Change from baseline habitual physical activity at 8 months

  • Habitual sedentary behavior

    Change from baseline habitual sedentary behavior at 8 months

  • Sedentary behavior

    Change from baseline habitual sedentary behavior at 8 months

Study Arms (4)

Individual Planning

EXPERIMENTAL

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.

Behavioral: Individual PlanningBehavioral: Education

Dyadic Planning

EXPERIMENTAL

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.

Behavioral: Dyadic PlanningBehavioral: Education

Collaborative Planning

EXPERIMENTAL

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.

Behavioral: Collaborative PlanningBehavioral: Education

Education

ACTIVE COMPARATOR

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.

Behavioral: Education

Interventions

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.

Individual Planning
Dyadic PlanningBEHAVIORAL

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.

Dyadic Planning

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.

Collaborative Planning
EducationBEHAVIORAL

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.

Collaborative PlanningDyadic PlanningEducationIndividual Planning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Social Sciences and Humanities

Wroclaw, 53-238, Poland

Location

Related Publications (9)

  • 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.

    PMID: 22454228BACKGROUND
  • 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.

    PMID: 22468716BACKGROUND
  • 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.

    PMID: 16095786BACKGROUND
  • 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.

    PMID: 15085902BACKGROUND
  • 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.

    PMID: 12900694BACKGROUND
  • 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.

    PMID: 24591064BACKGROUND
  • 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.

    PMID: 16480553BACKGROUND
  • 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.

    PMID: 21807446BACKGROUND
  • 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.

MeSH Terms

Conditions

Health Behavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Aleksandra Luszczynska, PhD

    SWPS University of Social Sciences and Humanities

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 5, 2017

Study Start

December 1, 2016

Primary Completion

February 28, 2020

Study Completion

September 30, 2021

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

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

Available IPD Datasets

Study Protocol Access

Locations