NCT00361478

Brief Summary

The study investigates the effect of the 'Mother and Baby' (M\&B) program on the psychological health and well-being of new mothers 6-10 weeks following the birth of their baby. The M\&B program is an 8-week program of group exercise and education sessions provided by various health professionals. The design of the study is a comprehensive cohort design, including a randomised controlled trial. The primary outcome measure is the Affect Balance Scale. The hypotheses are:

  1. 1.The M\&B program has a positive effect on new mothers' psychological health and well-being.
  2. 2.The M\&B program increases participation in regular physical activity.
  3. 3.the M\&B program benefits first time mothers more than women who have had more than one child.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_3

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

July 1, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
Last Updated

August 13, 2008

Status Verified

July 1, 2006

Enrollment Period

1.1 years

First QC Date

August 7, 2006

Last Update Submit

August 11, 2008

Conditions

Postnatal Depression

Keywords

exercisepostnatal depressionpsychological healthwell-being

Outcome Measures

Primary Outcomes (1)

  • Affect Balance Scale

    4 weeks

Secondary Outcomes (2)

  • Edinburgh Postnatal Depression Scale

    4 weeks

  • Exercise level

    4 weeks

Study Arms (2)

1

EXPERIMENTAL

"Mother and Baby" Program comprising exercise and education.

Behavioral: Exercise and education

2

ACTIVE COMPARATOR

Education only

Behavioral: Education

Interventions

Exercise and educationBEHAVIORAL

Weekly exercise and education program for 8 weeks

Also known as: Exercise
1
EducationBEHAVIORAL

Written educational material

Also known as: Educational material
2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women giving birth at the Angliss Hospital (primiparous and multiparous)

You may not qualify if:

  • Previous history of postnatal depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Angliss Hospital

Ferntree Gully, Victoria, 3156, Australia

Location

Related Publications (1)

  • Norman E, Sherburn M, Osborne RH, Galea MP. An exercise and education program improves well-being of new mothers: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):348-55. doi: 10.2522/ptj.20090139. Epub 2010 Jan 7.

    PMID: 20056720DERIVED

MeSH Terms

Conditions

Depression, PostpartumMotor ActivityPsychological Well-Being

Interventions

ExerciseEducational Status

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Mary P Galea, PhD

    University of Melbourne

    STUDY DIRECTOR

  • Emily Ashby, BPhysio

    The Angliss Hospital

    PRINCIPAL INVESTIGATOR

  • Margaret Sherburn, MWHlth

    University of Melbourne

    PRINCIPAL INVESTIGATOR

  • Richard Osborne, PhD

    University of Melbourne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2006

First Posted

August 8, 2006

Study Start

July 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

August 13, 2008

Record last verified: 2006-07

Locations

AU(1)