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First-time Parents Physical Activity Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290808
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ryan Rhodes, University of Victoria

Brief Summary:

This study will be investigating whether a theory-based physical activity intervention can maintain/improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over the eight months of having a child compared to a control group of new parents.

Hypothesis: The theory-based condition will change salient underlying motives (theory of planned behaviour constructs) for physical activity. Health-related fitness and quality of life will also be higher for this condition in comparison to the control condition. (Note: improvements in both groups of mothers may occur due to recovery from pregnancy, but our hypotheses will still hold). All outcomes will remain significantly higher at eight months in the theory-based condition compared to the standard condition


Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Theory-based group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: First-time Parents Physical Activity Intervention
Actual Study Start Date : March 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Theory-based group
The theory-based intervention group will receive strategies based on the Theory of Planned Behaviour to help increase physical activity among couples. Parents will receive materials on how to work together.
Behavioral: Theory-based group
Workbooks and mini-counselling sessions will be provided to participants in this group.

No Intervention: Information group
The information group will serve as the control group and will receive informational materials on the benefits of physical activity.



Primary Outcome Measures :
  1. Change in Objective and Self-report Physical activity [ Time Frame: Baseline, 6 weeks, 3.5 months, and 6 months ]
    Physical activity will be measured objectively for 7 consecutive days using the wGT3X-BT Activity Monitor combined with self-report of PA using the Godin Leisure-Time Exercise Questionnaire (LSI) at each time period.


Secondary Outcome Measures :
  1. Demographic information [ Time Frame: Baseline ]
    Basic information on gender, age, ethnicity, income, education level will be gathered.

  2. Health measures [ Time Frame: Baseline and 6 months ]
    Information on leave status, child care status, diet, sleep (Pittsburgh sleep quality index) and breastfeeding status, smoking, alcohol consumption will be included in this assessment.

  3. Motivation for physical activity [ Time Frame: Baseline, 6 weeks, 3.5 months, 6 months ]
    Motivation will be measured using the constructs of the theory of planned behaviour. Items will measure all components of the model (affective attitude, instrumental attitude, injunctive norm, descriptive norm, perceived control, planning) including behavioural, normative, and control beliefs.

  4. Health related quality of life/psychosocial distress [ Time Frame: Baseline, 6 weeks, 3.5 months, 6 months ]
    This will be assessed with parents using the Satisfaction with Life Scale. In addition, we will assess depressive and anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS), which also has sound reliability and validity compared to similar instruments.

  5. Health related fitness [ Time Frame: Baseline and 6 months ]
    We will assess the key components of health-related physical fitness including body composition, aerobic fitness and musculoskeletal fitness which are valid for males and females.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Married or common law couples
  • Living in Greater Victoria
  • Expecting first child
  • 18 years of age or older

Exclusion Criteria:

  • younger than 18
  • Expecting second or third child

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290808


Locations
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Canada, British Columbia
University of Victoria
Victoria, British Columbia, Canada, V8P-5C2
Sponsors and Collaborators
University of Victoria
Investigators
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Principal Investigator: Ryan Rhodes, PhD. University of Victoria
Study Director: Mark Beauchamp, PhD University of British Columbia
Study Director: Chris Blanchard, PhD Dalhousie
Study Director: Darren Warburton, PhD University of British Columbia
Study Director: Danielle Downs, PhD Penn State University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ryan Rhodes, Lead Investigator, University of Victoria
ClinicalTrials.gov Identifier: NCT02290808    
Other Study ID Numbers: 133614
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Keywords provided by Ryan Rhodes, University of Victoria:
physical
activity
exercise
new-parents
intervention
theory-based