Evaluating an eHealth Breastfeeding Resource

Study Overview
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Brief Summary
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This trial will evaluate an eHealth breastfeeding co-parenting resource designed for mothers and their co-parents. Couples will be randomized to study groups and the intervention group will receive information about this resource or the control group will receive usual care. The primary outcomes will be exclusive breastfeeding at 4 and 24 weeks postpartum.

Detailed Description
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This trial will evaluate an eHealth breastfeeding co-parenting resource designed for mothers and their co-parents. Couples will be randomized to study groups and the intervention group will receive information about this resource with an online demonstration and weekly emails for 6 weeks reminding them about the resource. The control group will receive usual care and 6 weekly emails reminding them that they are in the study. The primary outcomes will be exclusive breastfeeding at 4 and 24 weeks postpartum. Additional outcomes will include: breastfeeding initiation, duration, challenges, attitude, knowledge, confidence, anxiety, partners support and co-parenting.

Official Title
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Evaluating an eHealth Breastfeeding Resource for Mothers, Fathers, Partners and Co-parents

Conditions
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Breastfeeding, Exclusive, Breastfeeding

Intervention / Treatment
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* Other: eHealth Breastfeeding Co-parenting Resource


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older, over 25 weeks pregnant, planning to breastfeed, lives with co-parent who is willing to participate, first time mother or mother who has not previously breastfed, Exclusion Criteria: does not have access to the internet and telephone, does not reads and speaks English, does not lives in Ontario, Canada, is expecting more than one child with this pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 150 couples will be randomized to group allocation, intervention group or control group with use sequentially numbered opaque envelopes
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eHealth Intervention<br>This group will receive information about an eHealth breastfeeding co-parenting resource. They will have a short demonstration of the site and will receive weekly emails for 6 weeks reminding them about the resource and their participation in the study. | Other: eHealth Breastfeeding Co-parenting Resource<br>* The eHealth breastfeeding co-parenting resource was designed using a participatory model in partnership with the target population. It contains extensive information about breastfeeding and co-parenting. The topics include not only the importance of breastfeeding and technique but also information on how to manage common issues during breastfeeding establishment as well as over the child's first years, since breastfeeding is recommended to two years and beyond. Interactive learning elements, videos, and links to additional resources are included in the resources.<br>|
| No Intervention: Usual Care<br>This group will not receive any intervention. They will receive emails for 6 weeks reminding them that they are in the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Feeding Questionnaire | The primary outcome for this study is the rate of exclusive breastfeeding at 4 weeks postpartum. This is defined as no food or liquid other than breast milk (not even water) given to the infant and includes feeding expressed breast milk. However, under this definition of exclusive breastfeeding, undiluted drops or syrups consisting of vitamins, minerals supplements or medicines are included (Breastfeeding Committee for Canada, 2006; WHO, 2010). Exclusive breastfeeding will be determined by asking the mother what she has fed her baby in the last 7 days and what she usually feeds her baby. In this trial exclusive breastfeeding will be consistent with full breastfeeding described by Labbok and Krasovec (1990). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding Knowledge | This outcome will be assessed using a questionnaire designed for this study by a literature review and a group of breastfeeding experts including both professionals and lay individuals. The questionnaire included 32 items with scores ranging from 0-32. Each correct response was given a score of 1. Higher scores indicate greater breastfeeding knowledge. | baseline, 2 weeks post intervention, 4 weeks postpartum | 
| Breastfeeding Attitude | Iowa Infant Feeding Attitude Scale (IIFAS) measures attitude towards infant feeding methods. This scale consists of 17 items that cover various dimensions of infant feeding. The respondent indicate they agreed or disagreed with each statement, on a five point Likert scale that ranges from strongly agree (5) to strongly disagree (1). The items are worded so that about half are favourable of each feeding method. Items that favour formula feeding are then reverse scored. The items total score range from 17-85 and the lower scores reflect a preference for formula feeding whereas the higher scores reflect a preference for breastfeeding. (de la Mora, Russell, Dungy, Losch & Dusdieker, 1999). | baseline, 2 weeks post intervention, 4 weeks postpartum | 
| Breastfeeding Self-efficacy | To measure this variable the Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF; Dennis, 2003) will used. This instrument has 14 items. The response format is on a Likert scale, ranging from 'not at all confident' (1) to 'very confident' (5) where items are summed to produce a total score, ranging from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy. (Dennis, 2003) | baseline, 2 weeks post intervention, 4 weeks postpartum | 
| Anxiety | Mothers and co-parent will complete an Anxiety screening scale (GAD-7). This is a 7 item scale to measure generalized anxiety. The response format is on a Likert scale ranging from not at all (0) to nearly every day (3) where items are summed to produce a total score, ranging from 0 to 21, with higher scores indicating higher levels of generalized anxiety. (Spitzer, Kroenke, Williams & Löwe, 2006) | baseline, 2 weeks post intervention, 4 weeks postpartum, 12 weeks | 
| Partner support for infant feeding | A version of the Postpartum Partner Support Scale (PPSS) adapted for infant feeding is 22-item self-report instrument being used to assess partner infant-feeding-specific perceptions of support. This scale was developed to assess functional elements of support: appraisal/emotional, informational, and instrumental. Two items were included to examine negative support from the partner. Items are rated on a 4-point scale to produce a summative score ranging from 22 to 88, with higher scores indicating higher levels of infant feeding-specific partner support. (Dennis, Brown & Brennenstuhl, 2017) | 4 and 12 weeks postpartum | 
| Co-parenting infant feeding scale | Mother will complete a co-parenting infant feeding scale. This 15-item self-report instrument being used to assess co-parent infant feeding behaviours. This scale was developed to assess functional elements of breastfeeding coparenting framework. Items are rated on a 4-point scale to produce a summative score ranging from 15 to 60, with higher scores indicating higher levels of coparenting infant feeding behaviours. (Abbass-Dick & Dennis, 2017) | 4 and 12 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Co-parenting, eHealth, patient education, fathers