Effect of the 'Mother and Baby' Program on Well-Being
Condition: Postnatal Depression
MeSH terms: Depression, Postpartum; Depression
Study type: Interventional
Phase: Phase 3

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. 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.
    

Detailed description: 
      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.
    

Intervention name(s): Exercise and education; Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly exercise and education program for 8 weeks; Written educational material
Other intervention name(s): Exercise; Educational material
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: exercise; postnatal depression; psychological health; well-being