Online Intervention to Prevent Perinatal Depression and Promote Breastfeeding

"SunnysidePlus" will functionally integrate a web based intervention targeting skills to promote and support breastfeeding, manage mood,and prevent depression. Sunnyside Plus will build upon the previously tested "Sunnyside" intervention which targeted skills to manage mood through an interactive website with didactic material and tools. Women in weeks 20-28 of their pregnancy will be randomized to receive either Sunnyside Plus or Sunnyside. The Sunnyside intervention will consist of 6 weeks of online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Sunnyside Plus will include additional education and support to improve breastfeeding outcomes. Breastfeeding education and skills will be provided during the 6 weeks of online lessons during pregnancy. Breastfeeding support will continue through 6 weeks postpartum. This postpartum support will involve weekly online lessons, text support, and video support calls with a Lactation Educator provided on an as-needed basis. SunnysidePlus has the potential to provide a novel paradigm for improving breastfeeding outcomes and preventing depression; one that is accessible, highly scalable and cost-effective.

Study Overview

• Status: Completed
• Conditions: Depression; Breastfeeding
• Intervention / Treatment: Behavioral: Sunnyside; Behavioral: Sunnyside Plus

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female
• Black or African American
• 18 years and older
• Pregnant and between 20 and 28 weeks gestation
• Intend to breastfeed their child
• Have a score of 5-14 on the Patient Health Questionnaire-8 (PHQ-8)
• Have access to a broadband internet connection
• Are able to read and speak English

Exclusion Criteria:

• Are pregnant with multiples
• Have visual, hearing, voice, or motor impairment that would prevent completion of study procedures
• Diagnosed with a major depressive episode, psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder or other diagnosis for which participation in this trial is either inappropriate or dangerous based on self-report
• Are currently receiving treatment (medication or psychotherapy),have an intention to resume antidepressant medication after delivery (i.e., women who discontinued their medication during pregnancy).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Sunnyside; An online intervention to better manage mood during and after pregnancy.	Behavioral: Sunnyside; The Sunnyside intervention is an online intervention (an interactive website with didactic material and interactive tools) targeting skills to manage mood during and after pregnancy. The Sunnyside intervention will consist of 6weeks of online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Each lesson takes approximately 10 minutes to complete.
EXPERIMENTAL: Sunnyside Plus; An online intervention to better manage mood and promote and support breastfeeding during and after pregnancy.	Behavioral: Sunnyside Plus; Sunnyside Plus will build upon the Sunnyside intervention, plus include additional education and support to promote breastfeeding. Breastfeeding education and skills will be provided during the 6weeks of online lessons during pregnancy; each lesson takes approximately 10 minutes to complete. Breastfeeding support will continue through 6 weeks postpartum. This postpartum support will involve weekly online lessons(each taking approximately 10 minutes to complete), text support messages(3 sent during weeks 1 and 2, 2 sent during weeks 3 and 4, 1 sent during weeks 5 and 6), and video support calls with a Lactation Educator (LE)provided on an as-needed basis(exception: at least 1 video call is required during both week 1 postpartum and week 2 postpartum).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 is composed of 9 scored items and 1 unscored item which reflect overall functioning and impairment due to the depressive symptoms. PHQ-9 scoring interpretations are as follows: 1-4: minimal depressive symptoms; 5-9 mild depressive symptoms; 10-14: moderate depressive symptoms; 15-19: moderately severe depressive symptoms: 20-27: severe depressive symptoms.	2 weeks
Breastfeeding Status	Breastfeeding initiation, exclusivity, and duration will be assessed in the postpartum period.	Through 12 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago

Publications and helpful links

General Publications

• Pezley L, Tussing-Humphreys L, Koenig MD, Maki P, Odoms-Young A, Freels S, DiPiazza B, Cann F, Cares K, Depa C, Klejka G, Lima Oliveira M, Prough J, Roe T, Buscemi J, Duffecy J. Feasibility of a Web-Based Intervention to Prevent Perinatal Depression and Promote Human Milk Feeding: Randomized Pilot Trial. JMIR Form Res. 2022 May 3;6(5):e32226. doi: 10.2196/32226.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2020
• Primary Completion (ACTUAL): July 1, 2021
• Study Completion (ACTUAL): July 15, 2021

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (ACTUAL): October 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 2019-0519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No