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Effect of the 'Mother and Baby' Program on Well-Being

11 augusti 2008 uppdaterad av: University of Melbourne

Effect of the 'Mother and Baby' Program on New Mothers' Psychological and Physical Well-Being.

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

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

Background

The benefits of exercise, in particular group exercise, for women in early motherhood include improved body image, decreased anxiety, improved energy and building of social networks. Exercise has also been shown to be beneficial in the management of mood disorders such as depression and more specifically, postnatal depression. However there has been no suggestion that exercise may reduce symptoms of psychotic disorders that require medication, psychiatric therapy and possible hospitalisation. The number of women experiencing postnatal depression (PND) has increased to one in five women following childbirth. Some of the risks of development of PND include lack of social support during the childbearing year and lack of involvement in the community. new mothers have identified that reasons for inactivity include no child care, limited opportunity to exercise with their baby, reduced self-esteem, poor body image, or they are too busy. Research to date is limited and qualitative in nature, with no standardised measurement tools used to assess quality of life in postnatal women.

The 'Mother and Baby' (M&B) program is an 8-week program involving one hour of group exercise with mothers and their babies conducted by a physiotherapist and a 30-minute education session provided by various health professionals (physiotherapist, nutritionist, speech pathologist, psychologists and midwives). Education topics include baby massage, nutrition for mothers, introducing solids, adjusting to a new lifestyle, communicating with the baby, sun care for the baby and play development. The aim of the study is to explore the benefits of the M&B program on new mothers' psychological and physical well-being as well as the social benefits of exercise.

Research Plan

The design of the study is a comprehensive cohort design incorporating a randomised controlled trial (RCT)of the effects of the M&B program on the health of health women 6-10 weeks following the birth of their baby. The cohort design will complement the results of a classic RCT by allowing the investigation of outcomes in a setting that simulates the 'real-world' treatment process.

Women who have had their babies at the Angliss Hospital and are ready for discharge will be invited to participate in the study. Potential participants will be asked if they have a preference for the M&B program or Education sessions only, or if they would be willing to be part of an RCT. Those who agree to be part of the RCT will be randomised to M&B or Education only sessions. Allocation will be controlled by the chief investigator and will be concealed, with codes placed in opaque sealed enveloped. Randomisation will be stratified according to parity (first time mothers vs multiparous) and blocked in groups of 16.

All participants will receive and complete a questionnaire booklet and will return this in a pre-paid envelope. Questionnaires include:

  1. The Affect Balance Scale. This is the primary outcome measure. It is a highly reliable scale comprising ten questions indicating psychological reactions (positive and negative) to events in daily life.
  2. Edinburgh Postnatal Depression Scale. This is a widely used scale for the detection of risk factors for postnatal depression.
  3. Questions regarding exercise. Three questions regarding exercise will be asked and answers will be compared to tables of the number of metabolic equivalents (METS) required to perform the activity.
  4. Program evaluation. Participants undertaking the M&B program will complete a standardised evaluation form.

Sample size

A preliminary power calculation has been conducted from studies using the Affect Balance Scale in similar settings. With 80 subjects per group we will have 80% power to detect a 1.4 unit difference between the two groups. An advantage of 1.4 units (or 7% to 10% across a scale) is regarded as a clinically important difference. A pilot study will be undertaken to confirm the sample size.

Studietyp

Interventionell

Inskrivning (Faktisk)

160

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Victoria
      • Ferntree Gully, Victoria, Australien, 3156
        • The Angliss Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 45 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous history of postnatal depression

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 2
Education only
Written educational material
Andra namn:
  • Educational material
Experimentell: 1
"Mother and Baby" Program comprising exercise and education.
Weekly exercise and education program for 8 weeks
Andra namn:
  • Träning

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Affect Balance Scale
Tidsram: 4 weeks
4 weeks

Sekundära resultatmått

Resultatmått
Tidsram
Edinburgh Postnatal Depression Scale
Tidsram: 4 weeks
4 weeks
Exercise level
Tidsram: 4 weeks
4 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studierektor: Mary P Galea, PhD, University of Melbourne
  • Huvudutredare: Emily Ashby, BPhysio, The Angliss Hospital
  • Huvudutredare: Margaret Sherburn, MWHlth, University of Melbourne
  • Huvudutredare: Richard Osborne, PhD, University of Melbourne

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2005

Primärt slutförande (Faktisk)

1 augusti 2006

Avslutad studie (Faktisk)

1 augusti 2006

Studieregistreringsdatum

Först inskickad

7 augusti 2006

Först inskickad som uppfyllde QC-kriterierna

7 augusti 2006

Första postat (Uppskatta)

8 augusti 2006

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

13 augusti 2008

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 augusti 2008

Senast verifierad

1 juli 2006

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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