NCT00419211

Brief Summary

To refine, implement and evaluate a motivationally-tailored exercise intervention for increasing physical activity and mental health during pregnancy and the postpartum.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P75+ for early_phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

May 25, 2012

Status Verified

May 1, 2012

Enrollment Period

4.9 years

First QC Date

January 4, 2007

Last Update Submit

May 23, 2012

Conditions

Keywords

Pregnancy, Exercise, Depression

Outcome Measures

Primary Outcomes (3)

  • Physical Activity Level

    post-intervention and 3 months after felivery

  • Depressed Mood

    post-intervention and 3 months following delivery

  • Health related quality of life

    post-intervention and 3 months following delivery

Secondary Outcomes (6)

  • state anxiety

    post-intervention and 3 months following delivery

  • sleep quality

    post-intervention and 3 months following delivery

  • fatigue levels

    post-intervention and 3 months following delivery

  • exercise stage of change

    post-intervention and 3 months following delivery

  • self-efficacy for exercise

    post-intervention and 3 months following delivery

  • +1 more secondary outcomes

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Tailored exercise program

Behavioral: Exercise

No Intervention

NO INTERVENTION

Usual care group

Interventions

ExerciseBEHAVIORAL

Tailored exercise program

Lifestyle counseling

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant

You may not qualify if:

  • Regular participation in moderate intensity exercise for at least 30 minutes, 3 or more times a week at the time of study entry
  • Contraindications for participating in exercise during pregnancy as outlined by the SOGC/CSEP clinical practice guidelines
  • Inability to communicate in either English or French.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

DepressionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Deborah Da Costa, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 8, 2007

Study Start

January 1, 2007

Primary Completion

December 1, 2011

Last Updated

May 25, 2012

Record last verified: 2012-05

Locations