Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents (HHL)

O

OhioHealth

Status

Completed

Conditions

Breast Feeding

Treatments

Behavioral: Happy, Healthy, Loved

Study type

Interventional

Funder types

Other

Identifiers

NCT04578925
1296284

Details and patient eligibility

About

The purpose of this study is to test if a mobile device delivered intervention program can improve breast-feeding self-efficacy in primiparous mothers.

Full description

The proposed study will test if a mobile device based intervention program, called "Happy, Healthy, Loved (HHL)", will impact breast feeding rates and breastfeeding self-efficacy when compared to care as usual. Primiparous women and their partners will be randomly assigned to the HHL program or usual care.

Enrollment

128 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • primiparous mothers,
  • living with a partner or spouse,
  • have an intention to breastfeed their infant for at least 6-weeks postpartum;
  • whose infant is not in the Neonatal Intensive Care Unit,
  • have a mobile phone with text message capability,
  • have no current self-reported depressive episode, and;
  • English as a primary language

Exclusion criteria

  • mothers who have other biological children,
  • have infants in the Neonatal Intensive Care Unit,
  • do not have a mobile phone with text message capabilities,
  • report current episodes of depression, or are receiving antidepressant treatment or psychotherapy for depression,
  • 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)
  • do not speak, read and write English

Trial design

128 participants in 2 patient groups

Happy, Healthy, Loved
Experimental group
Description:
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.
Treatment:
Behavioral: Happy, Healthy, Loved
Control
No Intervention group
Description:
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.

Trial documents
3

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems