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

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)

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

496

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Warsaw, Poland, 03-815
        • University of Social Sciences and Humanities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

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.

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.

Experimental: Dyadic Planning

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.

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.

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).

Experimental: Collaborative Planning

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.

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.

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.

Active Comparator: Education
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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: Change from the baseline physical activity at 8 months
Accelerometry: ActiGraph (the model: wGT3X-B)
Change from the baseline physical activity at 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life (HRQOOL)
Time Frame: Change from baseline HRQOL at 8 months
WHOQOL-BREF (Skevington et al., 2004), the measure HRQOL among adults (parents)
Change from baseline HRQOL at 8 months
Health-related quality of life (HRQOL)
Time Frame: Change from baseline HRQOL at 8 months
KIDSCREEN-10 (Ravens-Sieberer et al., 2010); the measure HRQOL among children
Change from baseline HRQOL at 8 months
The use of planning
Time Frame: Change from baseline use of planning at 2 months
The self-reported use of planning (individual, dyadic and collaborative) questionnaire, based on Luszczynska (2006)
Change from baseline use of planning at 2 months
Body mass index (BMI)
Time Frame: Change from baseline BMI at 8 months
Certified and standardized body weight scales (Beurer; European Union safety certificate; measurement error < 5%) and measuring rods will be used. BMI will be calculated as body weight (in kilograms) divided by a square height (in meters)
Change from baseline BMI at 8 months
Physical activity behavior
Time Frame: Baseline (before the intervention) to 1 week after the first face-to face intervention session); Baseline to 6-month follow-up
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
Baseline (before the intervention) to 1 week after the first face-to face intervention session); Baseline to 6-month follow-up
Sedentary behavior
Time Frame: Baseline (before the intervention) to 1 week after the first face-to face intervention session); Baseline to 6-month follow-up
Accelerometry: ActiGraph (the model: wGT3X-B)
Baseline (before the intervention) to 1 week after the first face-to face intervention session); Baseline to 6-month follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Habitual physical activity
Time Frame: Change from baseline habitual physical activity at 8 months
Self-reported habit index (physical activity) questionnaire (Gardner et al., 2012)
Change from baseline habitual physical activity at 8 months
Habitual sedentary behavior
Time Frame: Change from baseline habitual sedentary behavior at 8 months
Self-reported habit index (sedentary behavior) questionnaire (Gardner et al., 2012)
Change from baseline habitual sedentary behavior at 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aleksandra Luszczynska, PhD, SWPS University of Social Sciences and Humanities

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

March 10, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimated)

March 18, 2016

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2014/15/B/HS6/00923_PCD
  • 2014/15/B/HS6/00923 (Other Grant/Funding Number: National Science Centre, Poland)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Study Data/Documents

  1. Study Protocol
    Information comments: The handbook with the protocol for experimenters (in English)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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