Clinical trial NCT03492411: Evaluating an eHealth Breastfeeding Resource
Official title: Evaluating an eHealth Breastfeeding Resource for Mothers, Fathers, Partners and Co-parents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breastfeeding, Exclusive
Breastfeeding
Keywords: Breastfeeding
Co-parenting
eHealth
patient education
fathers
Lead sponsor: University of Ontario Institute of Technology
Sponsor class: OTHER
Collaborators: name: Durham Region Health Department
First posted: 2018-04-10
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 150 couples will be randomized to group allocation, intervention group or control group with use sequentially numbered opaque envelopes
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant Feeding Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Breastfeeding Knowledge
timeFrame: baseline, 2 weeks post intervention, 4 weeks postpartum
measure: Breastfeeding Attitude
timeFrame: baseline, 2 weeks post intervention, 4 weeks postpartum
measure: Breastfeeding Self-efficacy
timeFrame: baseline, 2 weeks post intervention, 4 weeks postpartum
measure: Anxiety
timeFrame: baseline, 2 weeks post intervention, 4 weeks postpartum, 12 weeks
measure: Partner support for infant feeding
timeFrame: 4 and 12 weeks postpartum
measure: Co-parenting infant feeding scale
timeFrame: 4 and 12 weeks postpartum
Other outcomes:
Locations:
city: Oshawa
country: Canada
facility: University of Ontario Institute of Technology
state: Ontario
Study officials:
affiliation: Ms.
name: Jennifer Abbass-Dick
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Abbass-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.
citation: Dennis 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.
citation: Dennis 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.
citation: Spitzer 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.
citation: Abbass-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.
citation: Abbass-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.
citation: de 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.
citation: Labbok M, Krasovec K. Toward consistency in breastfeeding definitions. Stud Fam Plann. 1990 Jul-Aug;21(4):226-30.
citation: World Health Oraniazation. (2010). Indicators for Assessing Infant and Child Feeding Practices: part two measurement. Malta: WHO
citation: Breastfeeding Committee for Canada. (2006). Breastfeeding Definitions and Data Collection Periods.