NCT02290808

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

3.3 years

First QC Date

April 19, 2014

Last Update Submit

December 10, 2020

Conditions

Physical Activity

Keywords

physicalactivityexercisenew-parentsinterventiontheory-based

Outcome Measures

Primary Outcomes (1)

  • Change in Objective and Self-report Physical activity

    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.

    Baseline, 6 weeks, 3.5 months, and 6 months

Secondary Outcomes (5)

  • Demographic information

    Baseline

  • Health measures

    Baseline and 6 months

  • Motivation for physical activity

    Baseline, 6 weeks, 3.5 months, 6 months

  • Health related quality of life/psychosocial distress

    Baseline, 6 weeks, 3.5 months, 6 months

  • Health related fitness

    Baseline and 6 months

Study Arms (2)

Theory-based group

EXPERIMENTAL

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

Information group

NO INTERVENTION

The information group will serve as the control group and will receive informational materials on the benefits of physical activity.

Interventions

Theory-based groupBEHAVIORAL

Workbooks and mini-counselling sessions will be provided to participants in this group.

Theory-based group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • younger than 18
  • Expecting second or third child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Victoria

Victoria, British Columbia, V8P-5C2, Canada

Location

Related Publications (52)

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  • Rhodes RE, Blanchard CM, Hartson KR, Symons Downs D, Warburton DER, Beauchamp MR. Affective Response to Exercise and Affective Judgments as Predictors of Physical Activity Intention and Behavior among New Mothers in their first 6-Months Postpartum. Ann Behav Med. 2023 Apr 12;57(4):344-353. doi: 10.1093/abm/kaac067.

    PMID: 36745018DERIVED

  • Rhodes RE, Blanchard CM, Quinlan A, Symons Downs D, Warburton DER, Beauchamp MR. Couple-Based Physical Activity Planning for New Parents: A Randomized Trial. Am J Prev Med. 2021 Oct;61(4):518-528. doi: 10.1016/j.amepre.2021.04.020. Epub 2021 Jul 3.

    PMID: 34226094DERIVED

  • Quinlan A, Rhodes RE, Beauchamp MR, Symons Downs D, Warburton DER, Blanchard CM. Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial. BMC Public Health. 2017 Nov 9;17(1):875. doi: 10.1186/s12889-017-4874-7.

    PMID: 29121884DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ryan Rhodes, PhD.

    University of Victoria

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead Investigator

Study Record Dates

First Submitted

April 19, 2014

First Posted

November 14, 2014

Study Start

November 1, 2014

Primary Completion

March 1, 2018

Study Completion

July 1, 2018

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations

CA(1)