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

NCT02712255 | Withdrawn

• 2 other identifiers: 2014/15/B/HS6/00923_PPD2014/15/B/HS6/00923
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Physical activity

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

  Change from the 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 baseline physical activity at 8 months

Other Outcomes (2)

• Habitual physical activity

  Change from baseline habitual physical activity at 8 months

• Habitual sedentary behavior

  Change from baseline habitual sedentary behavior at 8 months

Study Arms (4)

Individual Planning

EXPERIMENTAL

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.

Behavioral: Individual Planning; Behavioral: Education

Dyadic Planning

EXPERIMENTAL

Participants 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

Behavioral: Dyadic Planning; Behavioral: Education

Collaborative Planning

EXPERIMENTAL

Participants 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.

Behavioral: Collaborative Planning; Behavioral: Education

Education

ACTIVE COMPARATOR

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 participant, (2) the examples of exercises and their metabolic equivalent; (3) information about healthy body mass and body composition.

Behavioral: Education

Interventions

Individual Planning BEHAVIORAL

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.

Individual Planning

Dyadic Planning BEHAVIORAL

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.

Dyadic Planning

Collaborative Planning BEHAVIORAL

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.

Collaborative Planning

Education BEHAVIORAL

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.

Collaborative Planning; Dyadic Planning; Education; Individual Planning

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• University of Social Sciences and Humanities, Warsaw: lead

Study Sites (1)

University of Social Sciences and Humanities

Warsaw, 03-815, 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: 22454228 BACKGROUND

• 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: 22468716 BACKGROUND

• 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: 16095786 BACKGROUND

• 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: 15085902 BACKGROUND

• 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: 12900694 BACKGROUND

• 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: 24591064 BACKGROUND

• 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: 16480553 BACKGROUND

• 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: 21807446 BACKGROUND

• Gardner B, Abraham C, Lally P, de Bruijn GJ. Towards parsimony in habit measurement: testing the convergent and predictive validity of an automaticity subscale of the Self-Report Habit Index. Int J Behav Nutr Phys Act. 2012 Aug 30;9:102. doi: 10.1186/1479-5868-9-102.

  PMID: 22935297 BACKGROUND

MeSH Terms

Conditions

Health Behavior; Motor Activity; Cardiovascular Diseases; Diabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population 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: March 10, 2016
• First Posted: March 18, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)