Clinical trial NCT04578925: Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents
Official title: Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Lead sponsor: OhioHealth
Sponsor class: OTHER
Collaborators: name: Denison University
name: Claremont McKenna College
First posted: 2020-10-08
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mother partner pairs will be randomly assigned to the HHL program or care as usual.
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Breastfeeding Self-Efficacy: Breastfeeding self-efficacy scale short form
timeFrame: 6 weeks postpartum
measure: Breastfeeding Self-Efficacy: Breastfeeding self-efficacy scale short form
timeFrame: 6 months postpartum
measure: Breastfeeding Rate
timeFrame: 6 weeks postpartum
measure: Breastfeeding Rate
timeFrame: 6 months postpartum
Secondary outcomes:
measure: Coping Behavior
timeFrame: 6 weeks postpartum
measure: Coping Behavior
timeFrame: 6 months postpartum
measure: Postpartum Partner Support
timeFrame: 6 weeks postpartum
measure: Partner Support
timeFrame: 6 weeks postpartum
measure: Postpartum Partner Support
timeFrame: 6 months postpartum
measure: Partner Support
timeFrame: 6 months postpartum
measure: Hair Cortisol
timeFrame: 0-2 days postpartum
measure: Sleep Quality (hair cortisol covariate): Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 0-2 days postpartum
measure: Postnatal Depression
timeFrame: 0-2 days postpartum
measure: Postnatal Depression
timeFrame: 6 weeks postpartum
measure: Postnatal Depression
timeFrame: 6 months postpartum
measure: Depression, Anxiety, Stress
timeFrame: 0-2 days postpartum
measure: Depression, Anxiety, Stress
timeFrame: 6 weeks postpartum
measure: Depression, Anxiety, Stress
timeFrame: 6 months postpartum
measure: Mood
timeFrame: 0-2 days postpartum
measure: Mood
timeFrame: 6 weeks postpartum
measure: Mood
timeFrame: 6 months postpartum
Other outcomes:
measure: Acceptability: Happy Healthy Loved Acceptability Scale
timeFrame: 6 weeks postpartum
measure: Acceptability: Happy Healthy Loved Acceptability Scale
timeFrame: 6 months postpartum
measure: Adherence
timeFrame: 6 months postpartum
Locations:
city: Columbus
country: United States
facility: OhioHealth
state: Ohio
Study officials:
affiliation: OhioHealth
name: Marie Cooper, RN
role: PRINCIPAL_INVESTIGATOR
References: