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

NCT04578925 | Completed

• 1 other identifier: 1296284
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Feeding

Outcome Measures

Primary Outcomes (4)

• Breastfeeding Self-Efficacy: Breastfeeding self-efficacy scale short form

  Breastfeeding self-efficacy scale short form (McCarter-Spaulding \& Dennis, 2010)- The Breastfeeding self-efficacy scale short form (BSES-SF) will be used to measure breastfeeding self-efficacy. The scores for this scale range from 1-5, with higher scores indicating greater self-efficacy related to breastfeeding.

  6 weeks postpartum

• Breastfeeding Self-Efficacy: Breastfeeding self-efficacy scale short form

  Breastfeeding self-efficacy scale short form (McCarter-Spaulding \& Dennis, 2010)- The Breastfeeding self-efficacy scale short form (BSES-SF) will be used to measure breastfeeding self-efficacy. The scores for this scale range from 1-5, with higher scores indicating greater self-efficacy related to breastfeeding.

  6 months postpartum

• Breastfeeding Rate

  Index of breastfeeding status - Women will be asked to identify the level that accurately described their breastfeeding behaviors within the previous 24 hours. Four levels will be reported: exclusive breastfeeding (breast milk only), partial breastfeeding (breast milk and at least 1 bottle of formula per day), token breastfeeding (breast given to comfort baby not for nutrition), and no breastfeeding. Higher values represent more exclusive breastfeeding.

  6 weeks postpartum

• Breastfeeding Rate

  Index of breastfeeding status - Women will be asked to identify the level that accurately described their breastfeeding behaviors within the previous 24 hours. Four levels will be reported: exclusive breastfeeding (breast milk only), partial breastfeeding (breast milk and at least 1 bottle of formula per day), token breastfeeding (breast given to comfort baby not for nutrition), and no breastfeeding. Higher values represent more exclusive breastfeeding.

  6 months postpartum

Secondary Outcomes (17)

• Coping Behavior

  6 weeks postpartum

• Coping Behavior

  6 months postpartum

• Postpartum Partner Support

  6 weeks postpartum

• Partner Support

  6 weeks postpartum

• Postpartum Partner Support

  6 months postpartum

Other Outcomes (3)

• Acceptability: Happy Healthy Loved Acceptability Scale

  6 weeks postpartum

• Acceptability: Happy Healthy Loved Acceptability Scale

  6 months postpartum

• Adherence

  6 months postpartum

Study Arms (2)

Happy, Healthy, Loved

EXPERIMENTAL

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.

Behavioral: Happy, Healthy, Loved

Control

NO INTERVENTION

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.

Interventions

Happy, Healthy, Loved BEHAVIORAL

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.

Happy, Healthy, Loved

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OhioHealth: lead
• Denison University: collaborator
• Claremont McKenna College: collaborator

Study Sites (1)

OhioHealth

Columbus, Ohio, 43214, United States

Location

Related Publications (1)

• 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.

  PMID: 39060974 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Marie Cooper, RN

  OhioHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study staff will randomize patients to the intervention or control arm and not inform subjects of their randomization assignment. Intervention group participants will receive text messages that provide resources and encouragement related to breast-feeding. Control group participants will receive text messages with non-breast-feeding related content.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mother partner pairs will be randomly assigned to the HHL program or care as usual.

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: October 8, 2020
• Study Start: October 1, 2020
• Primary Completion: September 26, 2022
• Study Completion: March 1, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)