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Completed

NCT Number: NCT02713438

Effects of Individual, Dyadic, and Collaborative Plans on Physical Activity in 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.

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Key information

Conditions

Health Behavior Behavior Body Weight Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Social Sciences and Humanities

Warsaw, 03-815, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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 child (parent-child dyads).

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

Education

Behavioral

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.

Primary outcomes

  1. Physical activity

    Time frame: Change from the baseline physical activity at 8 months

    Accelerometry: ActiGraph (the model: wGT3X-B)

Secondary outcomes

  1. 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)

  2. 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

  3. 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)

  4. 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)

  5. 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

  6. 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)

Other outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

University of Social Sciences and Humanities, Warsaw

Other

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2016
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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