Clinical trial NCT02713438: Effects of Individual, Dyadic, and Collaborative Plans on Physical Activity in Parent-Child Dyads
Official title: Physical Activity, and Health-Related Quality of Life: Dyadic Research in the Context of Forming Individual, Dyadic, and Collaborative Plans (Trial 1: Parent-Child Dyads)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Physical activity
Planning
Implementation intention
Quality of life
Body weight
Lead sponsor: University of Social Sciences and Humanities, Warsaw
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 496
Sex: ALL
Minimum age (years): 10
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 parent-child (aged 10-14) dyads, with 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.

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 schools (school nurse office) or/and participant's home. The same format, schedule, delivery, and setting will be used for conducting active control group procedures.

Eligibility criteria: Inclusion Criteria:

* Healthy children (age 10-14) and one healthy parents (any gender) or legal guardians
* Child or parent/legal guardian with chronic conditions but without contraindications for moderate intensity physical activity

Exclusion Criteria:

* Children younger than 10 years old
* Parents who declared plans for changing residence during the following year (e.g., due to moving to another region of the country)
* No parental consent at the baseline
* No child consent at the baseline
* Existing diseases with contraindications for moderate intensity physical activity

Primary outcomes:
measure: Physical activity
timeFrame: Change from the baseline physical activity at 8 months
Secondary outcomes:
measure: Health-related quality of life (HRQOOL)
timeFrame: Change from baseline HRQOL at 8 months
measure: Health-related quality of life (HRQOL)
timeFrame: Change from baseline HRQOL at 8 months
measure: The use of planning
timeFrame: Change from baseline use of planning at 2 months
measure: Body mass index (BMI)
timeFrame: Change from baseline BMI at 8 months
measure: Physical activity behavior
timeFrame: Baseline (before the intervention) to 1 week after the first face-to face intervention session); Baseline to 6-month follow-up
measure: Sedentary behavior
timeFrame: Baseline (before the intervention) to 1 week after the first face-to face intervention session); Baseline to 6-month follow-up
Other outcomes:
measure: Habitual physical activity
timeFrame: Change from baseline habitual physical activity at 8 months
measure: Habitual sedentary behavior
timeFrame: Change from baseline habitual sedentary behavior at 8 months
Locations:
city: Warsaw
country: Poland
facility: University of Social Sciences and Humanities
Study officials:
affiliation: SWPS University of Social Sciences and Humanities
name: Aleksandra Luszczynska, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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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.
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.
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.
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.