Clinical trial NCT03055871: Parents and Children Active Together Study
Official title: Parents and Children Active Together: Examining Motivational, Regulatory, and Habitual Intervention Approaches
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Activity
Keywords: Behavioural: Family physical activity habit
Lead sponsor: University of Victoria
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
name: University of British Columbia
First posted: 2017-02-16
Enrollment: 240
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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. 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

Eligibility 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.

Primary outcomes:
measure: Change from baseline in children's physical activity to 6 months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change from baseline to 6 months in child physical activity by parent proxy self-report
timeFrame: Baseline and 6 months
measure: Change from baseline in self-reported parental co-activity habit to 6 months
timeFrame: Baseline and 6 months
Other outcomes:
measure: TERTIARY OUTCOME - Change from baseline in parent physical activity to 6 months
timeFrame: Baseline and 6 months
measure: TERTIARY OUTCOME - Change from baseline to 6 months in self-reported parent physical activity
timeFrame: Baseline and 6 months
measure: TERTIARY OUTCOME - Change from baseline in self-reported parent-child co-activity to 6 months
timeFrame: Baseline and 6 months
measure: TERTIARY OUTCOME - Change from baseline in objectively assessed parent-child co-activity to 6 months.
timeFrame: Baseline and 6 months
measure: TERTIARY OUTCOME - Change from baseline in motivations (MPAC constructs) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: TERTIARY OUTCOME - Change from baseline in motivations (MPAC constructs) at 3 months
timeFrame: Baseline and 3 months
measure: TERTIARY OUTCOME - Change from baseline in motivations (MPAC constructs) at 6 months
timeFrame: Baseline and 6 months
measure: TERTIARY OUTCOME - Change from baseline in health-related quality of life at 6 months
timeFrame: Baseline and 6 months
measure: TERTIARY OUTCOME - Change from baseline in parental competence at 6 months
timeFrame: Baseline and 6 months
measure: TERTIARY OUTCOME - Change from baseline in family functioning at 6 months
timeFrame: Baseline and 6 months
measure: MANIPULATION CHECK - Change from baseline to 6 months in cue consistency
timeFrame: Baseline and 6 months
Locations:
city: Victoria
country: Canada
facility: Behavioural Medicine Lab
state: British Columbia
Study officials:
affiliation: University of Victoria
name: Ryan Rhodes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Mark Beauchamp, PhD
role: STUDY_CHAIR
affiliation: Dalhousie University
name: Chris Blanchard, PhD
role: STUDY_CHAIR
affiliation: University of Alberta
name: Valerie Carson, PhD
role: STUDY_CHAIR
affiliation: King's College
name: Benjamin Gardner, PhD
role: STUDY_CHAIR
affiliation: University of British Columbia
name: Darren Warburton, PhD
role: STUDY_CHAIR
References:
citation: Grant SJ, Beauchamp MR, Blanchard CM, Carson V, Gardner B, Warburton DER, Rhodes RE. Parents and children active together: a randomized trial protocol examining motivational, regulatory, and habitual intervention approaches. BMC Public Health. 2020 Sep 21;20(1):1436. doi: 10.1186/s12889-020-09465-z.