Trial record 6 of 10 for:    Open Studies | "Family Planning Services"

Family Planning to Promote Regular Physical Activity

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Victoria
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Dalhousie University
University of British Columbia
Information provided by (Responsible Party):
Ryan Rhodes, University of Victoria
ClinicalTrials.gov Identifier:
NCT01882192
First received: June 5, 2012
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.

Condition Intervention
Physical Activity
Behavioral: Family physical activity planning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Family Planning to Promote Regular Physical Activity: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Victoria:

Primary Outcome Measures:
  • Change from baseline in children's physical activity at 6 months [ Time Frame: baseline & 6 months ] [ Designated as safety issue: No ]
    Children's physical activity will be quantified by accelerometry. Children 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.


Secondary Outcome Measures:
  • Change from baseline in parent's physical activity at 6 months [ Time Frame: baseline & 6 months ] [ Designated as safety issue: No ]
    Parent's physical activity will be quantified by accelerometry. Parents will wear an accelerometer for 7 days at baseline, 6 weeks, 3 and 6 months, for a minimum of 10 hours per day.

  • Change from baseline in motivation at 6 weeks [ Time Frame: baseline & 6 weeks ] [ Designated as safety issue: No ]
    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. The Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2) will be completed by both parents and the target child. Change in motivation variables will be examined (6 weeks minus baseline).

  • Change from baseline in self-reported family based physical activity and personal physical activity at 6 weeks [ Time Frame: baseline & 6 weeks ] [ Designated as safety issue: No ]
    The target child will complete a modified version of the Physical Activity Questionnaire for Children (PAQ-C) to assess habitual moderate to vigorous physical activity. The Godin Leisure-Time Exercise Questionnaire (LSI) will be used to measure self-reported 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).

  • Change from baseline in health-related quality of life / psychosocial distress at 6 months [ Time Frame: baseline & 6 months ] [ Designated as safety issue: No ]
    Quality of life will be assessed with parents using the Satisfaction with Life Scale and the 12 item Short Form Health Survey. The target child's quality of life will be assessed using the 5-item Satisfaction with Life Scale Adapted for Children (SWLS-C). Change in health-related quality of life/ psychosocial distress from baseline to 6 months (i.e., post-intervention) will be examined.

  • Change from baseline in physical home environment at 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    The physical home environment will be assessed using three sections from the Active Where surveys (i.e., Section A. equipment checklist, Section P. Home Environment, & Section R. Sedentary Behavior). The Active Where surveys include items designed to to assess how the physical environment impacts the physical activity and eating behaviors of youth. Change in physical environment will be examined from baseline to 6 months (post-intervention).

  • Change from baseline in body composition at 6 months. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Skinfolds (triceps, biceps, subscapular, supra iliac, medial calf) will be measured using standard anthropometric procedures. Change in body mass index (BMI), waist circumference, and sum of 5 sites will be examined from baseline to 6 months (post-intervention)

  • Change from baseline in cardiovascular fitness at 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    A submaximal cycle ergometer test on a calibrated Monark cycle ergometer will be used to assess cardiovascular fitness in both parents and target child. Heart rate, and blood pressure (sphygmomanometer and a stethoscope) will be monitored at rest and during exercise. Change in cardiovascular fitness from baseline to 6 months (i.e., post-intervention) will be examined.

  • Change from baseline in motivation at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    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. The BREQ-2 will be completed by both parents and the target child. Change in motivation variables will be examined (3 months minus baseline).

  • Change from baseline in self-reported physical activity at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    The target child will complete a modified version of the PAQ-C to assess habitual moderate to vigorous physical activity. The LSI will be used to measure self-reported 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).

  • Change from baseline in motivation at 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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. The BREQ-2 will be completed by both parents and the target child. Change in motivation variables will be examined (6 months minus baseline).

  • Change from baseline in self-reported physical activity at 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    The target child will complete a modified version of the PAQ-C to assess habitual moderate to vigorous physical activity. The LSI will be used to measure self-reported 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)

  • Change from baseline in physical activity habits at 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Physical activity habits will be measured using 4 items.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Change from baseline in musculoskeletal fitness at 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Grip strength, push ups, sit & reach flexibility, partial curl-ups, vertical jump,and back extension will be measured to determine the musculoskeletal fitness of both the children and parents using the Canadian CSEP standardized protocols. Change in musculoskeletal fitness from baseline to 6 months (i.e., post-intervention) will be examined.


Estimated Enrollment: 160
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family physical activity planning
The intervention condition will receive the same guidelines as the comparison condition but will also be provided with family physical activity planning material.
Behavioral: Family physical activity planning
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.
No Intervention: Control
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882192

Contacts
Contact: Greg Mulligan 250-472-5288 bml@uvic.ca

Locations
Canada, British Columbia
Behavioural Medicine Laboratory Recruiting
Victoria, British Columbia, Canada, V8P 5C2
Contact: Greg Mulligan    250-472-5288    bml@uvic.ca   
Principal Investigator: Ryan E Rhodes, PhD         
Sponsors and Collaborators
University of Victoria
Canadian Institutes of Health Research (CIHR)
Dalhousie University
University of British Columbia
Investigators
Principal Investigator: Ryan Rhodes, PhD University of Victoria
Study Chair: Chris Blanchard, PhD Dalhousie University
Study Chair: Darren Warburton, PhD University of British Columbia
Study Chair: Patti Jean Naylor, PhD University of Victoria
  More Information

No publications provided

Responsible Party: Ryan Rhodes, Professor, University of Victoria
ClinicalTrials.gov Identifier: NCT01882192     History of Changes
Other Study ID Numbers: CIHR113798
Study First Received: June 5, 2012
Last Updated: June 17, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Victoria:
family
physical activity
planning

ClinicalTrials.gov processed this record on July 24, 2014