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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011385
• Other study ID #: 2014/15/B/HS6/00923_C
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2023
• Source: University of Social Sciences and Humanities, Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: September 30, 2021
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• Individual Planning
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
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
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
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.

Locations

Country	Name	City	State
Poland	University of Social Sciences and Humanities	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
University of Social Sciences and Humanities, Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Habitual physical activity	Self-reported habit index questionnaire for physical activity (based on Gardner et al., 2012)	Change from baseline habitual physical activity at 8 months
Other	Habitual sedentary behavior	Self-reported habit index questionnaire for sedentary behavior (based on Gardner et al., 2012)	Change from baseline habitual sedentary behavior at 8 months
Other	Sedentary behavior	Accelerometry: ActiGraph (the model: wGT3X-B)	Change from baseline habitual sedentary behavior at 8 months
Primary	Physical activity	Accelerometry: ActiGraph (the model: wGT3X-B)	Change from baseline physical activity at 8 months
Secondary	Health-related quality of life (HRQOL)	WHOQOL--BREF Questionnaire (Skevington et al., 2004)	Change from baseline HRQOL at 8 months
Secondary	The use of planning	The self-reported use of planning questionnaire (individual, dyadic and collaborative), based on Luszczynska (2006)	Change from baseline use of planning at 2 months
Secondary	Body mass index (BMI)	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
Secondary	Physical activity	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