Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents
NCT ID: NCT04578925
Last Updated: 2023-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2020-10-01
2023-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Happy, Healthy, Loved
Both parents will complete surveys on a tablet during the postpartum hospital stay. Surveys cover three topic areas related to breast-feeding; modeling and feedback, partner support, and stress coping. For the next 6 weeks participants' will receive 4 personalized text messages per week based on their tablet survey responses. Participants will be asked one yes/no question each week ("still breastfeeding? Text Y for yes, N for no"). Once a "no" response has been received from a participant, all remaining text messages will emphasize coping and partner support rather than breastfeeding.
Happy, Healthy, Loved
A text message based, mobile-device delivered intervention that provides educational information to primiparous mothers and their partners about breast-feeding and coping with stress.
Control
Control group participants will complete surveys on a tablet during the postpartum hospital stay. Surveys cover three topic areas related to breast-feeding; modeling and feedback, partner support, and stress coping. The control group participants will be sent 4 text messages per week for the first 6 weeks, but the content of the texts will be non-breastfeeding related. The content will instead summarize infant development facts.
No interventions assigned to this group
Interventions
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Happy, Healthy, Loved
A text message based, mobile-device delivered intervention that provides educational information to primiparous mothers and their partners about breast-feeding and coping with stress.
Eligibility Criteria
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Inclusion Criteria
2. living with a partner or spouse,
3. have an intention to breastfeed their infant for at least 6-weeks postpartum;
4. whose infant is not in the Neonatal Intensive Care Unit,
5. have a mobile phone with text message capability,
6. have no current self-reported depressive episode, and;
7. English as a primary language
Exclusion Criteria
2. have infants in the Neonatal Intensive Care Unit,
3. do not have a mobile phone with text message capabilities,
4. report current episodes of depression, or are receiving antidepressant treatment or psychotherapy for depression,
5. have initial study survey that indicates suicide risks (participants who are identified as suicidal ideation at 6 weeks or 6 months will receive further assessment and referral but not be excluded from the program because it may be more harmful and penalizing to remove them from the program if they find it helpful. We will remind the participant that continuing is voluntary and there is no penalty if they wish to discontinue participation)
6. do not speak, read and write English
18 Years
FEMALE
No
Sponsors
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Denison University
UNKNOWN
Claremont McKenna College
OTHER
OhioHealth
OTHER
Responsible Party
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Principal Investigators
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Marie Cooper, RN
Role: PRINCIPAL_INVESTIGATOR
OhioHealth
Locations
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OhioHealth
Columbus, Ohio, United States
Countries
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References
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Henshaw E, Cooper M, Wood T, Krishna S, Lockhart M, Doan S. A randomized controlled trial of the Happy, Healthy, Loved personalized text-message program for new parent couples: impact on breastfeeding self-efficacy and mood. BMC Pregnancy Childbirth. 2024 Jul 26;24(1):506. doi: 10.1186/s12884-024-06684-9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Maternal Informed Consent
Document Type: Informed Consent Form: Partner Informed Consent
Other Identifiers
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1296284
Identifier Type: -
Identifier Source: org_study_id
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