Breastfeeding, ExclusiveNCT03492411
Evaluating an eHealth Breastfeeding Resource
A study testing eHealth Breastfeeding Co-parenting Resource in people with Breastfeeding, Exclusive and Breastfeeding, run by University of Ontario Institute of Technology at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive, Breastfeeding
- What is being tested?
- eHealth Breastfeeding Co-parenting Resource
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteCanada
- Study dates
- 25 Mar 2018to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Ontario Institute of Technology
Oshawa, Ontario, L3T 4L3
About this study
Official title: Evaluating an eHealth Breastfeeding Resource for Mothers, Fathers, Partners and Co-parents
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.
Read the detailed description
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.
- Conditions
- Breastfeeding, Exclusive, Breastfeeding
- Being tested
- eHealth Breastfeeding Co-parenting Resource
- Keywords
- Breastfeeding, Co-parenting, eHealth, patient education, fathers
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth Breastfeeding Co-parenting ResourceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| eHealth Intervention | Experimental | 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. Receives: Other: eHealth Breastfeeding Co-parenting Resource |
| Usual Care | No intervention | This group will not receive any intervention. They will receive emails for 6 weeks reminding them that they are in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 4 and 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start25 Mar 2018
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 150 couples will be randomized to group allocation, intervention group or control group with use sequentially numbered opaque envelopes
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ontario Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Durham Region Health Department
- Responsible party
- Principal investigator, Jennifer Abbass-Dick, University of Ontario Institute of Technology
- Investigators
- Jennifer Abbass-Dick, Principal investigator, Ms.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492411
- Sponsor's protocol ID
- v3vt62d9
- Status last verified
- Mar 2020
- First submitted
- 22 Feb 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbass-Dick J, Xie F, Koroluk J, Alcock Brillinger S, Huizinga J, Newport A, Goodman WM, Dennis CL. The Development and piloting of an eHealth breastfeeding resource targeting fathers and partners as co-parents. Midwifery. 2017 Jul;50:139-147. doi: 10.1016/j.midw.2017.04.004. Epub 2017 Apr 18.
PubMed 28448858Abbass-Dick J, Dennis CL. Breast-feeding Coparenting Framework: A New Framework to Improve Breast-feeding Duration and Exclusivity. Fam Community Health. 2017 Jan/Mar;40(1):28-31. doi: 10.1097/FCH.0000000000000137.
PubMed 27870751Dennis CL, Brown HK, Brennenstuhl S. The Postpartum Partner Support Scale: Development, psychometric assessment, and predictive validity in a Canadian prospective cohort. Midwifery. 2017 Nov;54:18-24. doi: 10.1016/j.midw.2017.07.018. Epub 2017 Jul 29.
PubMed 28780475Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
PubMed 14649593Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Abbass-Dick J, Dennis CL. Maternal and paternal experiences and satisfaction with a co-parenting breastfeeding support intervention in Canada. Midwifery. 2018 Jan;56:135-141. doi: 10.1016/j.midw.2017.10.005. Epub 2017 Oct 18.
PubMed 29101865Abbass-Dick J, Stern SB, Nelson LE, Watson W, Dennis CL. Coparenting breastfeeding support and exclusive breastfeeding: a randomized controlled trial. Pediatrics. 2015 Jan;135(1):102-10. doi: 10.1542/peds.2014-1416. Epub 2014 Dec 1.
PubMed 25452653de la Mora, A., Russell, D. W., Dungy, C.I., Losch, M., & Dusdieker, L. (1999). The Iowa Infant Feeding Attitude Scale: Analysis of reliability and validity. Journal of Applied Social Psychology, 29, 2362-2380.
Labbok M, Krasovec K. Toward consistency in breastfeeding definitions. Stud Fam Plann. 1990 Jul-Aug;21(4):226-30.
PubMed 2219227World Health Oraniazation. (2010). Indicators for Assessing Infant and Child Feeding Practices: part two measurement. Malta: WHO
Breastfeeding Committee for Canada. (2006). Breastfeeding Definitions and Data Collection Periods.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an eHealth Breastfeeding Resource for Mothers, Fathers, Partners and Co-parents
- ClinicalTrials.gov ID
- NCT03492411
- Acronym / sponsor ID
- v3vt62d9
- Conditions
- Breastfeeding, Exclusive, Breastfeeding
- Keywords
- Breastfeeding, Co-parenting, eHealth, patient education, fathers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of Ontario Institute of TechnologyUniversity, hospital or other
- Collaborators
- Durham Region Health Department
- Study start
- 25 Mar 2018 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 150 couples will be randomized to group allocation, intervention group or control group with use sequentially numbered opaque envelopes
| Arm | Type | Receives |
|---|---|---|
| eHealth Intervention | Experimental | Other: eHealth Breastfeeding Co-parenting ResourceThis 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. |
| Usual Care | No intervention | –This group will not receive any intervention. They will receive emails for 6 weeks reminding them that they are in the study. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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,
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth Breastfeeding Co-parenting ResourceThe 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. | Other | eHealth Intervention |
Primary outcome
Infant Feeding Questionnaire
Time frame: 4 weeks
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).
6 secondary outcomes
Breastfeeding Knowledge
Time frame: baseline, 2 weeks post intervention, 4 weeks postpartum
Breastfeeding Attitude
Time frame: baseline, 2 weeks post intervention, 4 weeks postpartum
Breastfeeding Self-efficacy
Time frame: baseline, 2 weeks post intervention, 4 weeks postpartum
Anxiety
Time frame: baseline, 2 weeks post intervention, 4 weeks postpartum, 12 weeks
Partner support for infant feeding
Time frame: 4 and 12 weeks postpartum
Co-parenting infant feeding scale
Time frame: 4 and 12 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Background: PubMed 28448858Abbass-Dick J, Xie F, Koroluk J, Alcock Brillinger S, Huizinga J, Newport A, Goodman WM, Dennis CL. The Development and piloting of an eHealth breastfeeding resource targeting fathers and partners as co-parents. Midwifery. 2017 Jul;50:139-147. doi: 10.1016/j.midw.2017.04.004. Epub 2017 Apr 18.
- Background: PubMed 27870751Abbass-Dick J, Dennis CL. Breast-feeding Coparenting Framework: A New Framework to Improve Breast-feeding Duration and Exclusivity. Fam Community Health. 2017 Jan/Mar;40(1):28-31. doi: 10.1097/FCH.0000000000000137.
- Background: PubMed 28780475Dennis CL, Brown HK, Brennenstuhl S. The Postpartum Partner Support Scale: Development, psychometric assessment, and predictive validity in a Canadian prospective cohort. Midwifery. 2017 Nov;54:18-24. doi: 10.1016/j.midw.2017.07.018. Epub 2017 Jul 29.
- Background: PubMed 14649593Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 29101865Abbass-Dick J, Dennis CL. Maternal and paternal experiences and satisfaction with a co-parenting breastfeeding support intervention in Canada. Midwifery. 2018 Jan;56:135-141. doi: 10.1016/j.midw.2017.10.005. Epub 2017 Oct 18.
- Background: PubMed 25452653Abbass-Dick J, Stern SB, Nelson LE, Watson W, Dennis CL. Coparenting breastfeeding support and exclusive breastfeeding: a randomized controlled trial. Pediatrics. 2015 Jan;135(1):102-10. doi: 10.1542/peds.2014-1416. Epub 2014 Dec 1.
- Backgroundde la Mora, A., Russell, D. W., Dungy, C.I., Losch, M., & Dusdieker, L. (1999). The Iowa Infant Feeding Attitude Scale: Analysis of reliability and validity. Journal of Applied Social Psychology, 29, 2362-2380.
- Background: PubMed 2219227Labbok M, Krasovec K. Toward consistency in breastfeeding definitions. Stud Fam Plann. 1990 Jul-Aug;21(4):226-30.
- BackgroundWorld Health Oraniazation. (2010). Indicators for Assessing Infant and Child Feeding Practices: part two measurement. Malta: WHO
- BackgroundBreastfeeding Committee for Canada. (2006). Breastfeeding Definitions and Data Collection Periods.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Abbass-Dick principal investigator
Ms.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth Breastfeeding Co-parenting Resource in people with Breastfeeding, Exclusive and Breastfeeding, run by University of Ontario Institute of Technology at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Feeding Questionnaire (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03492411, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020; AzTrials last refreshed its copy on 30 Oct 2026.