None listed
Conditions
Brief summary
This 3-year RCT will involve the development, implementation and evaluation of an intervention to increase the duration of breastfeeding amongst participating families in metropolitan Perth WA. The study will require the development and testing of additional intervention elements to enhance those already developed during the FIFI trial. This will be followed by the implementation of a RCT involving a sample of 1200 parents (1200 fathers and 1200 mothers) recruited from hospitals in the Perth metropolitan area. The interventions will consist of a control group intervention (the usual antenatal education offered by that hospital), two medium interventions groups and one high level intervention group. Beneficial outcomes may include increased duration of breastfeeding, delaying the use of infant formula and solid foods, a better start to life for the infants and less potential disease later in life. The study will also explore the cost effectivness of each of the three interventions.
Interventions
There are three (3) interventions - two medium level and one high level. Medium intervention 1 will consist of an additional specialised 1 hour antenatal education session delivered to the fathers when the mother is at least 32 weks gestation. The session content will focus on fatherhood and the positive role of fathers in relation to breastfeeding support, the importance/benefits of breast feeding to infants and mothers and anticipatory problem solving (eg. for breastfeeding issues like engorg
There are three (3) interventions - two medium level and one high level. Medium intervention 1 will consist of an additional specialised 1 hour antenatal education session delivered to the fathers when the mother is at least 32 weks gestation. The session content will focus on fatherhood and the positive role of fathers in relation to breastfeeding support, the importance/benefits of breast feeding to infants and mothers and anticipatory problem solving (eg. for breastfeeding issues like engorgement and mastitis). Infant developmental milestones and postnatal depression will also be specifically included. In addition, fathers will receive associated take-home educational print material for both parents to support the anticipatory problem solvoing and decision making component of the session. For medium intervention 2, the content will be similar to that for medium intervention 1 but it will be delivered sequentially with information relevant to the infant developmental milestones at the time. Material will be delivered to the father via the internet and mobile phone technology on a weekly basis for the first 6 weeks after birth and then every two weeks from 6-26 weeks or until breastfeeding stops, if earlier than 26 weeks. Materials will include goal setting exercises and short quizzes. Links to web-based materials will be provided, which participants will access using a unique log-in. High intervention comprises medium intervention 1 and medium intervention 2 combined (ie specialised antenatal class and social support). Process evaluation at the end of the intervention will determine participant self-reported use and acceptance of materials with questions included in the final questionnaire. Participation in phone app exercises and visits to web-pages can also be monitored at the participant level.
Sponsors
Curtin University
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For couples to be eligible to participate they must own a ‘Smart’ phone and have internet access, reside within WA, both partners must intend to participate in the rearing of their child and there are no existing medical conditions in the mother that are likely to inhibit the initiation of breastfeeding or exclusive breastfeeding.
Exclusion criteria
Couples don't own a ‘Smart’ phone nor have internet access, don't reside within WA, both partners don't intend to participate in the rearing of their child, couples are same sex and there are existing medical conditions in the mother that are likely to inhibit the initiation of breastfeeding or exclusive breastfeeding.
Outcome results
None listed