Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-24 @ 10:32 PM
Study NCT ID:
NCT01882192
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2012-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Planning to Promote Regular Physical Activity
Sponsor:
University of Victoria
Organization:
Study Overview
Official Title:
Family Planning to Promote Regular Physical Activity: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary research question is:
1\) Does the planning condition improve adherence to regular physical activity compared to the control condition at six months? Hypothesis: Adherence will be higher for the planning condition in comparison to the more standard physical activity education condition. The effect may wane over time from the initial measurement period but all outcomes will remain significantly higher at six months.
Secondary Research Questions
1. Does the planning condition improve motivational, health-related quality of life, and health-related fitness outcomes compared to the control condition at six months?
Hypothesis: The planning condition will not affect intentions or underlying motives (theory of planned behaviour constructs) for physical activity because its effect on behavior is to tie initial intentions better to behavioural action (i.e., behavioural regulation) and not to enhance motivation. Health-related fitness and quality of life, however, will be higher for the planning condition in comparison to the standard physical activity education intervention condition. The effect may wane over time from the initial measurement period but all outcomes will remain significantly higher at six months in the planning condition compared to the standard physical activity education group.
2. Can group differences among these motivational, behavioural, and health-related fitness outcomes be explained through a mediation model? Hypothesis: The covariance of the assigned conditions (planning, education) on use/adherence will be explained by planning and use of behavioural regulation strategies (i.e., manipulation check). In turn, the covariance between planning and behavioural regulation strategies and health-related outcomes will be explained by physical activity adherence among conditions.
3. Can motivational variables predict adherence? Do these differ by condition?
Hypothesis: The approach will test Ajzen's theory of planned behavior, extended by the concept of active planning. Affective attitude and perceived behavioural control will predict intention, intention will predict planning and planning will predict adherence across conditions.
4. Is there an intergenerational, seasonal, or gender difference across primary outcomes by assigned condition? Hypothesis: Children will show greater adherence to the planning condition than their parents. No differences in gender or season are hypothesized but these are exploratory research questions because there is limited research at present to make any definitive statement.
1\) Does the planning condition improve adherence to regular physical activity compared to the control condition at six months? Hypothesis: Adherence will be higher for the planning condition in comparison to the more standard physical activity education condition. The effect may wane over time from the initial measurement period but all outcomes will remain significantly higher at six months.
Secondary Research Questions
1. Does the planning condition improve motivational, health-related quality of life, and health-related fitness outcomes compared to the control condition at six months?
Hypothesis: The planning condition will not affect intentions or underlying motives (theory of planned behaviour constructs) for physical activity because its effect on behavior is to tie initial intentions better to behavioural action (i.e., behavioural regulation) and not to enhance motivation. Health-related fitness and quality of life, however, will be higher for the planning condition in comparison to the standard physical activity education intervention condition. The effect may wane over time from the initial measurement period but all outcomes will remain significantly higher at six months in the planning condition compared to the standard physical activity education group.
2. Can group differences among these motivational, behavioural, and health-related fitness outcomes be explained through a mediation model? Hypothesis: The covariance of the assigned conditions (planning, education) on use/adherence will be explained by planning and use of behavioural regulation strategies (i.e., manipulation check). In turn, the covariance between planning and behavioural regulation strategies and health-related outcomes will be explained by physical activity adherence among conditions.
3. Can motivational variables predict adherence? Do these differ by condition?
Hypothesis: The approach will test Ajzen's theory of planned behavior, extended by the concept of active planning. Affective attitude and perceived behavioural control will predict intention, intention will predict planning and planning will predict adherence across conditions.
4. Is there an intergenerational, seasonal, or gender difference across primary outcomes by assigned condition? Hypothesis: Children will show greater adherence to the planning condition than their parents. No differences in gender or season are hypothesized but these are exploratory research questions because there is limited research at present to make any definitive statement.
Detailed Description:
Background:
Obesity is rapidly becoming one of the more serious public health challenges of this century, especially when considering that overweight and obese children are likely to stay obese into adulthood and are at a higher risk of developing chronic diseases at a younger age. The need for changes to modifiable risk factors associated with obesity and chronic diseases is paramount. Physical activity is associated with the reduction of several chronic diseases in adults, including breast cancer, colorectal cancer, CVD, stroke, high blood pressure, type 2 diabetes, osteoporosis, and hypertension. In children 5 to 17 years old, physical activity and high physical fitness help guard against high blood pressure, high blood cholesterol, metabolic syndrome, low bone density, depression, injuries, and obesity. Unfortunately in Canada, well over half the adult population, and almost half the child population, are not active enough to reap these health benefits. Children spend considerable time within the care of their parents, and indeed parents appear to be the 'gatekeepers' of children and their experiences during family time. Our review of 34 intergenerational studies showed that parental support was synonymous with physical activity in their children. Thus, focusing on the parent as a means to changing youth physical activity appears a necessity. At present, physical activity interventions focused on the family are limited and have resulted in negligible changes. A recent review of these studies demonstrated very low success in producing behavior change - considerably lower than the comparable adult literature. The authors suggest that focused research attention needs to be placed on the family in order to improve our current practice of physical activity promotion. Our pilot study \[15\], which serves as the template for this research proposal, demonstrated that focused planning on when, what, how, where, and overcoming other expected barriers followed by prompts and cues resulted in a significant change in physical activity over the more standard persuasion/education approach. The following proposal is an extension of this line of successful research with improvements to the methodological rigor and sample generalizability used in the pilot study.
Target population:
The targeted population will be inactive families within the Greater Victoria Area, British Columbia.
Sample size:
A total of 160 families will be recruited (n=80 per group).
Intervention:
The intervention will follow the prior work conducted in our successful pilot trial. The standard (comparison group) package will consist of Canada's family guide to physical activity guidelines recommending 60 minutes of activity a day in bouts as short as five to ten minutes for children and a breakdown of ways for the family to achieve this physical activity (structured, unstructured, endurance, strength, activities, less than 60 minutes of sustained sedentary activity, reduce screen viewing by 30 min per day) commensurate with this guide. This will include the new insert by CSEP. The guide also contains arguments and information about the benefits of physical activity.
The intervention condition will receive the same guidelines as the comparison condition but will also be provided with family physical activity planning material. This material will include skill training content (workbook how to plan for family physical activity) and practical material to create a plan (i.e., a colourful dry erase wall calendar for family activities with fridge magnets). The skill training material for planning is based on several streams of prior work in the adult physical activity literature. Families were instructed to plan for "when," "where," "how," and "what" physical activity will be performed commensurate with the creation of implementation intentions/action planning. The workbook, however, also focuses on problem solving barriers to physical activity which is more akin to coping planning and traditional goal setting. The design of all material was created for the pilot study and features graphic design and colour images that represent family physical activity.
Obesity is rapidly becoming one of the more serious public health challenges of this century, especially when considering that overweight and obese children are likely to stay obese into adulthood and are at a higher risk of developing chronic diseases at a younger age. The need for changes to modifiable risk factors associated with obesity and chronic diseases is paramount. Physical activity is associated with the reduction of several chronic diseases in adults, including breast cancer, colorectal cancer, CVD, stroke, high blood pressure, type 2 diabetes, osteoporosis, and hypertension. In children 5 to 17 years old, physical activity and high physical fitness help guard against high blood pressure, high blood cholesterol, metabolic syndrome, low bone density, depression, injuries, and obesity. Unfortunately in Canada, well over half the adult population, and almost half the child population, are not active enough to reap these health benefits. Children spend considerable time within the care of their parents, and indeed parents appear to be the 'gatekeepers' of children and their experiences during family time. Our review of 34 intergenerational studies showed that parental support was synonymous with physical activity in their children. Thus, focusing on the parent as a means to changing youth physical activity appears a necessity. At present, physical activity interventions focused on the family are limited and have resulted in negligible changes. A recent review of these studies demonstrated very low success in producing behavior change - considerably lower than the comparable adult literature. The authors suggest that focused research attention needs to be placed on the family in order to improve our current practice of physical activity promotion. Our pilot study \[15\], which serves as the template for this research proposal, demonstrated that focused planning on when, what, how, where, and overcoming other expected barriers followed by prompts and cues resulted in a significant change in physical activity over the more standard persuasion/education approach. The following proposal is an extension of this line of successful research with improvements to the methodological rigor and sample generalizability used in the pilot study.
Target population:
The targeted population will be inactive families within the Greater Victoria Area, British Columbia.
Sample size:
A total of 160 families will be recruited (n=80 per group).
Intervention:
The intervention will follow the prior work conducted in our successful pilot trial. The standard (comparison group) package will consist of Canada's family guide to physical activity guidelines recommending 60 minutes of activity a day in bouts as short as five to ten minutes for children and a breakdown of ways for the family to achieve this physical activity (structured, unstructured, endurance, strength, activities, less than 60 minutes of sustained sedentary activity, reduce screen viewing by 30 min per day) commensurate with this guide. This will include the new insert by CSEP. The guide also contains arguments and information about the benefits of physical activity.
The intervention condition will receive the same guidelines as the comparison condition but will also be provided with family physical activity planning material. This material will include skill training content (workbook how to plan for family physical activity) and practical material to create a plan (i.e., a colourful dry erase wall calendar for family activities with fridge magnets). The skill training material for planning is based on several streams of prior work in the adult physical activity literature. Families were instructed to plan for "when," "where," "how," and "what" physical activity will be performed commensurate with the creation of implementation intentions/action planning. The workbook, however, also focuses on problem solving barriers to physical activity which is more akin to coping planning and traditional goal setting. The design of all material was created for the pilot study and features graphic design and colour images that represent family physical activity.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: