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Clinical Trials/NCT04578925
NCT04578925
Completed
Not Applicable

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

OhioHealth1 site in 1 country128 target enrollmentOctober 1, 2020
ConditionsBreast Feeding

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Feeding
Sponsor
OhioHealth
Enrollment
128
Locations
1
Primary Endpoint
Breastfeeding Self-Efficacy: Breastfeeding self-efficacy scale short form
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
March 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
OhioHealth
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 6 months postpartum

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.

Breastfeeding Rate

Time Frame: 6 months postpartum

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.

Secondary Outcomes

  • Hair Cortisol(0-2 days postpartum)
  • Mood(6 months postpartum)
  • Postnatal Depression(6 months postpartum)
  • Coping Behavior(6 months postpartum)
  • Postpartum Partner Support(6 months postpartum)
  • Partner Support(6 months postpartum)
  • Sleep Quality (hair cortisol covariate): Pittsburgh Sleep Quality Index (PSQI)(0-2 days postpartum)
  • Depression, Anxiety, Stress(6 months postpartum)

Study Sites (1)

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