Clinical trial NCT03145688: Family Habit Physical Activity Study
Official title: Promoting Habit Formation in Family Physical Activity
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: Heart and Stroke Foundation of Canada
name: University of British Columbia
name: Dalhousie University
name: University of Alberta
name: King's College London
First posted: 2017-05-09
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
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. Does the habit formation condition improve child health-related quality of life, and health-related fitness outcomes compared to the control and planning conditions at six months? Hypothesis: Child health-related fitness and quality of life will be higher for the habit formation condition in comparison to the control and planning conditions.
2. Can group differences among behavioural, and health-related fitness outcomes be explained through a mediation model? Hypothesis: The covariance of the assigned conditions (habit formation, planning + education, education control) on child physical activity will be explained by parental support habit, and through the use of consistency and cues regulation strategies (i.e., manipulation check). In turn, the covariance between support habit and health-related outcomes will be explained by physical activity among conditions. The habit formation condition will not affect parental support intentions or underlying outcome expectations (benefits of physical activity) for support of child physical activity because its effect on behavior is to tie initial intentions to behavioural action or to work independent of goals and intentions.
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 physical activity via some activities being performed with their children in comparison to the other conditions. No differences in gender or season are hypothesized but these are exploratory research questions because there is limited research at present \[28\] to make any definitive statement.

Eligibility criteria: Inclusion Criteria:

* parents with children between the ages of 6 and 12 years
* self-report low family physical activity
* target child is not meeting Canada's Physical Activity guidelines

Exclusion Criteria:

• participant is unsafe to participate in physical activity as determined by answers to the Physical Activity Readiness Questionnaire (PAR-Q)

Primary outcomes:
measure: Change from baseline in children's physical activity to 6 months
timeFrame: Baseline & 6 months
Secondary outcomes:
measure: Change from baseline in personal physical activity to six months (child PA)
timeFrame: Baseline & 6 months
measure: Change from baseline in self-reported family based physical activity to six months
timeFrame: Baseline & 6 months
measure: Change from baseline in weight at 6 months
timeFrame: baseline and 6 months
measure: Change from baseline in height at 6 months
timeFrame: baseline and 6 months
measure: Change from baseline in waist circumference at 6 months
timeFrame: baseline and 6 months
measure: Change from baseline in BMI at 6 months
timeFrame: baseline and 6 months
measure: Change from baseline in grip strength at 6 months (MSK fitness)
timeFrame: baseline and 6 months
measure: Change from baseline in sit and reach flexibility at 6 months
timeFrame: baseline and 6 months
measure: Change from baseline in plank test time at 6 months
timeFrame: baseline and 6 months
measure: Change from baseline in cardiovascular fitness at 6 months
timeFrame: baseline and 6 months
measure: Change from baseline in parent support of child's physical activity at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from baseline in parent support of child's physical activity at 3 months
timeFrame: baseline and 3 months
measure: Change from baseline in parent support of child's physical activity at 6 months
timeFrame: baseline and 6 months
measure: Change from baseline in parent support habits of child physical activity at 6 months (a)
timeFrame: baseline and 6 months
Other outcomes:
measure: TERTIARY OUTCOME - Change from baseline in personal physical activity to 6 months (parent)
timeFrame: Baseline and 6 months
measure: TERTIARY OUTCOME - Change from baseline in health-related quality of life at 6 months
timeFrame: baseline & 6 months
measure: TERTIARY OUTCOME - Change from baseline in family functioning at 6 months
timeFrame: baseline and 6 months
measure: TERTIARY OUTCOME - Change from baseline in motivations (MPAC constructs) at 6 weeks
timeFrame: baseline & 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: Change from baseline to 6 months in cue consistency (manipulation check)
timeFrame: Baseline and 6 months
Locations:
city: Victoria
country: Canada
facility: Behavioural Medicine Lab, University of Victoria
state: British Columbia
Study officials:
affiliation: University of Victoria
name: Ryan Rhodes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University
name: Chris Blanshard, PhD
role: STUDY_CHAIR
affiliation: University of Alberta
name: Valerie Carson, PhD
role: STUDY_CHAIR
affiliation: King's College London
name: Benjamin Gardner, PhD
role: STUDY_CHAIR
affiliation: University of British Columbia
name: Darren Warburton, PhD
role: STUDY_CHAIR
affiliation: University of British Columbia
name: Mark Beauchamp, PhD
role: STUDY_CHAIR
References:
citation: Medd ER, Beauchamp MR, Blanchard CM, Carson V, Gardner B, Warburton DE, Rhodes RE. Family-based habit intervention to promote parent support for child physical activity in Canada: protocol for a randomised trial. BMJ Open. 2020 Apr 14;10(4):e033732. doi: 10.1136/bmjopen-2019-033732.