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Parents and Children Active Together Study

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ClinicalTrials.gov Identifier: NCT03055871
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : June 7, 2019
Sponsor:
Collaborators:
Canadian Cancer Society Research Institute (CCSRI)
University of British Columbia
Information provided by (Responsible Party):
Ryan Rhodes, University of Victoria

Brief Summary:

The purpose of this study is to examine physical activity habit formation in parents and if this can increase moderate to vigorous physical activity behavior in their children over six months.The Primary Research Question is:

Does the habit formation condition result in increased moderate-vigorous intensity physical activity of the child compared to the control (education) and education + planning conditions at six months? Hypothesis: Child physical activity will be higher for the habit formation condition in comparison to the more standard physical activity education and planning conditions at six months.


Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Habit formation intervention Behavioral: Physical activity planning intervention Not Applicable

Detailed Description:

Secondary Research Questions

  1. Can group differences among behavioural outcomes be explained through a mediation model? Hypothesis: The covariance of the assigned conditions (habit formation, planning + education, education control) on child PA will be explained by parental co-activity habit, and through the use of consistency and cues regulation strategies (i.e., manipulation check). The habit formation condition will not affect parental support intentions or underlying outcome expectations (benefits of PA) for support of child PA because its effect on behavior is to tie initial intentions to behavioural action or to work independent of goals and intentions.
  2. Is there an intergenerational, seasonal, or gender difference across primary outcomes by assigned condition? Hypothesis: Parents in the habit formation condition will show higher PA via the activities being performed with their children in comparison to the other conditions. No differences in gender or season are hypothesized based on the current research at present

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Parents and Children Active Together: Examining Motivational, Regulatory, and Habitual Intervention Approaches
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard education control group
The control group package will consist of Canada's PA guidelines recommending 180 min per week for young children, transitioning to 60 minutes of activity a day for children at five and a breakdown of ways for the parent to help their child achieve this PA (unstructured, endurance, strength, activities) commensurate with this guide. The guide also contains arguments and information about the benefits of PA.
Physical activity planning intervention
The physical activity planning intervention condition will receive the same guidelines as the standard education control group but will also be provided with family physical activity planning material. This material will include workbook on how to plan for family physical activity; brainstorming exercise for children where they list physical activities that they have found fun in the past, as well as activities that they would find enjoyable to do as a family.
Behavioral: Physical activity planning intervention
This arm will receive the control education content, but will also be provided with family PA planning material. This material will include skill training content (workbook on how to plan for family PA). The material includes a brainstorming exercise for parents where they list physical activities they think their children have found fun in the past, as well as activities that they would find enjoyable to do as a family. We also have Canadian parental survey data on the most preferred co-physical activities for children 3-6. We will provide this material as prompts/suggestions. This list helps create the template for PA planning by contextualizing what the parents would like to do with their kids.

Habit formation intervention
The habit formation intervention condition will receive the same content as the education control condition and the physical activity planning condition but with additional material on creating physical activity support habits. The material includes a brief discussion of what habits are with some very straightforward examples such as preparing for sleep routines, or initiating to drive a car to work. A key component of the habit section will be based on planning for context-dependent repetition, with pointers on how to maintain repetition as habit forms.
Behavioral: Habit formation intervention
In addition to the control content and the planning content, this intervention will include material provided to the family that assists with creating physical activity support habits. The material contains a discussion of what habits are, straightforward examples, planning and pointers for forming habits. A key component of the habit intervention will be planning for context-dependent repetition.




Primary Outcome Measures :
  1. Change from baseline in children's physical activity to 6 months [ Time Frame: Baseline and 6 months ]
    Children's physical activity will be quantified by accelerometry. Children will wear an accelerometer for a minimum of 6 hours per day for 7 days at baseline and 6 months. Additionally this measure will assess intermediate outcomes at 6 weeks and 3 months.


Secondary Outcome Measures :
  1. Change from baseline in self-reported child physical activity, family-based physical activity and personal physical activity at 6 weeks [ Time Frame: Baseline and 6 weeks ]
    The parent will complete a modified Godin Leisure-Time Exercise Questionnaire by parent proxy report for physical activity of the target child to assess habitual moderate to vigorous physical activity. The Godin Leisure-Time Exercise Questionnaire (LSI) will be used to measure self-reported family-based physical activity and physical activity in parents. The LSI contains three questions, which assess the frequency of mild, moderate, and strenuous activity performed for at least 15 minutes during free time in a typical week. Change in self-reported physical activity will be examined (6 weeks minus baseline).

  2. Change from baseline in self-reported child physical activity, family-based physical activity and personal physical activity at 3 months [ Time Frame: Baseline and 3 months ]
    The parent will complete a modified Godin Leisure-Time Exercise Questionnaire (LSI) by parent proxy report for physical activity of the target child to assess habitual moderate to vigorous physical activity. The LSI will also be used to measure self-reported family-based physical activity and physical activity in parents. The LSI contains three questions, which assess the frequency of mild, moderate, and strenuous activity performed for at least 15 minutes during free time in a typical week. Change in self-reported physical activity will be examined (3 months minus baseline).

  3. Change from baseline in self-reported child physical activity, family-based physical activity and personal physical activity at 6 months [ Time Frame: Baseline and 6 months ]
    The parent will complete a modified Godin Leisure-Time Exercise Questionnaire (LSI) by parent proxy report for physical activity of the target child to assess habitual moderate to vigorous physical activity. The LSI will also be used to measure self-reported family-based physical activity and physical activity in parents. The LSI contains three questions, which assess the frequency of mild, moderate, and strenuous activity performed for at least 15 minutes during free time in a typical week. Change in self-reported physical activity will be examined (6 months minus baseline).

  4. Change from baseline in motivation at 6 weeks [ Time Frame: Baseline and 6 weeks ]
    Motivations for family based physical activity and personal physical activity will be measured using the constructs of the TPB and SDT including affective attitude, instrumental attitude, injunctive norm, descriptive norm, perceived control, behavioural, normative, control beliefs, intrinsic motivation, extrinsic motivation, and amotivation. Change in motivation variables will be examined (6 weeks minus baseline).

  5. Change from baseline in motivation at 3 months [ Time Frame: Baseline and 3 months ]
    Motivations for physical activity will be using the constructs of the TPB and SDT including affective attitude, instrumental attitude, injunctive norm, descriptive norm, perceived control, behavioural, normative, control beliefs, intrinsic motivation, extrinsic motivation, and amotivation. Change in motivation variables will be examined (3 months minus baseline).

  6. Change from baseline in motivation at 6 months [ Time Frame: Baseline and 6 months ]
    Motivations for physical activity will be using the constructs of the TPB and SDT including affective attitude, instrumental attitude, injunctive norm, descriptive norm, perceived control, behavioural, normative, control beliefs, intrinsic motivation, extrinsic motivation, and amotivation. Change in motivation variables will be examined (6 months minus baseline).

  7. Change from baseline in health-related quality of life/psychosocial distress at 6 months [ Time Frame: Baseline and 6 months ]
    Quality of life will be assessed with parents using the 12 item Short Form Health Survey. Change in health-related quality of life/ psychosocial distress from baseline to 6 months (i.e., post-intervention) will be examined.

  8. Change from baseline in physical activity habits at 6 months [ Time Frame: Baseline and 6 months ]
    Physical activity habits will be measured using 4 items.

  9. Change from baseline to 6 months in cue consistency [ Time Frame: Baseline and 6 months ]
    Cue consistency will be assessed using a 6 item survey. Changes in cue consistency will be examined (6 months minus baseline).

  10. Change from baseline to 6 months in Parent Support Identity [ Time Frame: Baseline and 6 months ]
    Parent support identity will be measured via a modified exercise identity scale. Changes in support identity will be examined (6 months minus baseline).

  11. Change from baseline to 6 months in Parental Habit for Co-activity [ Time Frame: Baseline and 6 months ]
    Parental Habit for Co-activity will be measured using 12 items. Changes in Parent Habit for Co-activity will be examined (6 months minus baseline).

  12. Change from baseline in strategies and goal commitment for family based physical activity and personal physical activity at 6 weeks [ Time Frame: Baseline and 6 weeks ]
    Strategies for planning family based physical activity and personal physical activity will be measure using 12 items. Changes in strategies and goal commitment will be examined (6 weeks minus baseline).

  13. Change from baseline in strategies and goal commitment for family based physical activity and personal physical activity at 3 months [ Time Frame: Baseline and 3 months ]
    Strategies for planning family based physical activity and personal physical activity will be measure using 12 items. Changes in strategies and goal commitment will be examined (3 months minus baseline).

  14. Change from baseline in strategies and goal commitment for family based physical activity and personal physical activity at 6 months [ Time Frame: Baseline and 6 months ]
    Strategies for planning family based physical activity and personal physical activity will be measure using 12 items. Changes in strategies and goal commitment will be examined (6 months minus baseline).



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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants will be at least one parent with at least one child between the ages of 3 and 5 years. Families will reside in greater Victoria, British Columbia. Parents can be single parents or co-parents (i.e. we only require one parent and one child to participate). Families will be included if they have at least one parent who will participate and one child between the ages of 3 and 5 who is not meeting current physical activity guidelines (>=60 minutes a day of moderate to vigorous physical activity. There will be no delimitations to the sample based on socio-economic or ethnic variables.

Exclusion Criteria:

  • Exclusion Criteria: If child is meeting the current physical activity guidelines >=60 minutes a day of moderate to vigorous physical activity per day.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055871


Locations
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Canada, British Columbia
Behavioural Medicine Lab Recruiting
Victoria, British Columbia, Canada, V8P 5C2
Contact: Stina Grant, BA    250 472 5288    bml@uvic.ca   
Principal Investigator: Ryan Rhodes, PhD         
Sponsors and Collaborators
University of Victoria
Canadian Cancer Society Research Institute (CCSRI)
University of British Columbia
Investigators
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Principal Investigator: Ryan Rhodes, PhD University of Victoria
Study Chair: Mark Beauchamp, PhD University of British Columbia
Study Chair: Chris Blanchard, PhD Dalhousie University
Study Chair: Valerie Carson, PhD University of Alberta
Study Chair: Benjamin Gardner, PhD King's College
Study Chair: Darren Warburton, PhD University of British Columbia

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Responsible Party: Ryan Rhodes, Professor, University of Victoria
ClinicalTrials.gov Identifier: NCT03055871     History of Changes
Other Study ID Numbers: 704959
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ryan Rhodes, University of Victoria:
Behavioural: Family physical activity habit