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

NCT ID: NCT04578925

Last Updated: 2023-07-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-03-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Mother partner pairs will be randomly assigned to the HHL program or care as usual.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
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.

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.

Group Type EXPERIMENTAL

Happy, Healthy, Loved

Intervention Type 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.

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.

Group Type NO_INTERVENTION

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. primiparous mothers,
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

1. mothers who have other biological children,
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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Denison University

UNKNOWN

Sponsor Role collaborator

Claremont McKenna College

OTHER

Sponsor Role collaborator

OhioHealth

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Cooper, RN

Role: PRINCIPAL_INVESTIGATOR

OhioHealth

Locations

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OhioHealth

Columbus, Ohio, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 39060974 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Maternal Informed Consent

View Document

Document Type: Informed Consent Form: Partner Informed Consent

View Document

Other Identifiers

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1296284

Identifier Type: -

Identifier Source: org_study_id

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