Parents and Children Active Together Study

Physical Activity Clinical Trial

Official title:

Parents and Children Active Together: Examining Motivational, Regulatory, and Habitual Intervention Approaches

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03055871
• Other study ID #: 704959
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: August 2023

Study information

• Verified date: November 2022
• Source: University of Victoria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. Do factors such as quality of life, parental competence, and family functioning improve with increased PA? Hypothesis: Conditions that increase PA will show commensurate increases in these factors.

3. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Behavioural Medicine Lab	Victoria	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of Victoria	Canadian Cancer Society (CCS), University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TERTIARY OUTCOME - Change from baseline in parent physical activity to 6 months	Parental physical activity will be quantified by accelerometry. Parents will wear an accelerometer for a minimum of 10 hours per day for 7 days at baseline and 6 months. Additionally this measure will assess intermediate outcomes at 6 weeks and 3 months.	Baseline and 6 months
Other	TERTIARY OUTCOME - Change from baseline to 6 months in self-reported parent physical activity	As a tertiary outcome measure, the Godin Leisure-Time Exercise Questionnaire will be used to measure self-reported physical activity at baseline, 6 weeks, 3 months, 6 months. Questions assess intensity, frequency, and duration of physical activity in an average week.	Baseline and 6 months
Other	TERTIARY OUTCOME - Change from baseline in self-reported parent-child co-activity to 6 months	Parents will complete a modified Godin Leisure Time Exercise Questionnaire to assess parent-child co-activity. This measure will be assessed at baseline, 6 weeks, 3 months, and 6 months. Intermediate outcomes will be at 6 weeks and 3 months.	Baseline and 6 months
Other	TERTIARY OUTCOME - Change from baseline in objectively assessed parent-child co-activity to 6 months.	An accelerometer Bluetooth-enabled feature measures proximity detection, allowing for the objective assessment of co-activity between parent and child. Parent and child will wear accelerometers at baseline, 6 weeks, 3 months, and 6 months to assess co-activity. Intermediate co-activity outcomes will be at 6 weeks and 3 months.	Baseline and 6 months
Other	TERTIARY OUTCOME - Change from baseline in motivations (MPAC constructs) at 6 weeks	Tertiary Outcome Measure Motivations for parent-child co-activity will be measured using affective attitude, instrumental attitude, perceived capability, behavioural regulation, intention, automaticity and identity. These measures are all part of the Multi Process Action Control Framework (MPAC).	Baseline and 6 weeks
Other	TERTIARY OUTCOME - Change from baseline in motivations (MPAC constructs) at 3 months	Tertiary Outcome Measure Motivations for parent-child co-activity will be measured using affective attitude, instrumental attitude, perceived capability, behavioural regulation, intention, automaticity and identity. These measures are all part of the Multi Process Action Control Framework (MPAC).	Baseline and 3 months
Other	TERTIARY OUTCOME - Change from baseline in motivations (MPAC constructs) at 6 months	Tertiary Outcome Measure Motivations for parent-child co-activity will be measured using affective attitude, instrumental attitude, perceived capability, behavioural regulation, intention, automaticity and identity. These measures are all part of the Multi Process Action Control Framework (MPAC).	Baseline and 6 months
Other	TERTIARY OUTCOME - Change from baseline in health-related quality of life at 6 months	Tertiary Outcome Measure Quality of life will be assessed with parents using the 12 item Short Form Health Survey. Change in health-related quality of life from baseline to 6 months (i.e., post-intervention) will be examined with intermediate time points of 6 weeks and 3 months as well.	Baseline and 6 months
Other	TERTIARY OUTCOME - Change from baseline in parental competence at 6 months	Tertiary Outcome Measure Parental competence will be measured via the Parenting Sense of Competence Scale at baseline and 6 months with intermediate time points of 6 weeks and 3 months.	Baseline and 6 months
Other	TERTIARY OUTCOME - Change from baseline in family functioning at 6 months	Tertiary Outcome Measure Family Environment Scale is used to assess family functioning at baseline, 6 weeks, 3 months, and 6 months.	Baseline and 6 months
Other	MANIPULATION CHECK - Change from baseline to 6 months in cue consistency	To examine the manipulation check outcomes, a 6 item survey assessing the utilization of context-dependent repetition/cues and consistency/repeated action is used. Changes in cue consistency will be examined at 6 months with intermediate time points of 6 weeks and 3 months.	Baseline and 6 months
Primary	Change from baseline in children's physical activity to 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.	Baseline and 6 months
Secondary	Change from baseline to 6 months in child physical activity by parent proxy self-report	The parent will complete a modified Godin Leisure-Time Exercise Questionnaire to report physical activity of the target child to assess habitual moderate to vigorous physical activity at baseline, 6 weeks, 3 months, 6 months. Questions assess intensity, frequency, and duration of physical activity in an average week. Additionally this measure will assess intermediate outcomes at 6 weeks and 3 months.	Baseline and 6 months
Secondary	Change from baseline in self-reported parental co-activity habit to 6 months	The parent will complete an adapted self-reported habit strength index for co-activity with their child at baseline, 6 weeks, 3 months, and 6 months. Intermediate outcomes will be at 6 weeks and 3 months.	Baseline and 6 months