An interventional study of eHealth Breastfeeding Co-parenting Resource in Breastfeeding, Exclusive and Breastfeeding, sponsored by University of Ontario Institute of Technology. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 88 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by University of Ontario Institute of Technology · Not applicable, Interventional, and Prevention
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.
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.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's enrollment of 217 is above the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →University of Ontario Institute of Technology is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
This group will not receive any intervention. They will receive emails for 6 weeks reminding them that they are in the study.
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.
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).
Time frame: 4 weeks
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.
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 4 and 12 weeks postpartum
Plan to share: No
Started Mar 2018 (actual). Primary completion is estimated for May 2020, 25 months after the start.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 25 months is above that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Ontario Institute of Technology