NCT02713438

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
496

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 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

First Submitted

Initial submission to the registry

March 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

7.6 years

First QC Date

March 10, 2016

Last Update Submit

December 13, 2023

Conditions

Keywords

Physical activityPlanningImplementation intentionQuality of lifeBody weight

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    Accelerometry: ActiGraph (the model: wGT3X-B)

    Change from the baseline physical activity at 8 months

Secondary Outcomes (6)

  • Health-related quality of life (HRQOOL)

    Change from baseline HRQOL at 8 months

  • 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 behavior

    Baseline (before the intervention) to 1 week after the first face-to face intervention session); Baseline to 6-month follow-up

  • +1 more secondary outcomes

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 PlanningBehavioral: 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 child. The parent is actively participating in forming plans by the child. 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 PlanningBehavioral: Education

Collaborative Planning

EXPERIMENTAL

Participants are filling in the planning forms jointly. Planning refers to physical activity of both persons in the dyad (child and parent). 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 PlanningBehavioral: Education

Education

ACTIVE COMPARATOR

The education group received 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

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 forms their plans individually, without consulting the dyadic partner, but discussing the plans with the experimenter.

Individual Planning
Dyadic PlanningBEHAVIORAL

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 child (parent-child dyads).

Dyadic Planning

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 (parent and child) and include some plans for joint physical activity.

Collaborative Planning
EducationBEHAVIORAL

CONTENT: The education materials address physical activity and healthy nutrition guidelines for age groups. 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 parent-child dyad and discusses individual guidelines for both dyadic partners.

Collaborative PlanningDyadic PlanningEducationIndividual Planning

Eligibility Criteria

Age10 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 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
  • Ravens-Sieberer U, Erhart M, Rajmil L, Herdman M, Auquier P, Bruil J, Power M, Duer W, Abel T, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J; European KIDSCREEN Group. Reliability, construct and criterion validity of the KIDSCREEN-10 score: a short measure for children and adolescents' well-being and health-related quality of life. Qual Life Res. 2010 Dec;19(10):1487-500. doi: 10.1007/s11136-010-9706-5. Epub 2010 Jul 30.

    PMID: 20668950BACKGROUND
  • 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

MeSH Terms

Conditions

Health BehaviorMotor ActivityBody Weight

Interventions

Educational Status

Condition Hierarchy (Ancestors)

BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

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

March 10, 2016

First Posted

March 18, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

December 14, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Data will be made publicly available in 3 years after the completion of the trial

Available IPD Datasets

Study Protocol Access

Locations