Feasibility of a Web-Based Intervention to Prevent Perinatal Depression and Promote Human Milk Feeding: Randomized Pilot Trial

Background Mothers who identify as Black or African American are more likely to report depressed moods in late pregnancy and early postpartum and have the lowest rates of human milk feeding compared with all other racial groups in the United States. Internet interventions offer the potential to extend preventative and supportive services as they address key barriers, particularly for those navigating the complex and vulnerable early postpartum period. However, there is limited evidence on the feasibility of such interventions for preventing perinatal mental health disorders and improving human milk feeding outcomes in Black mothers. Objective This pilot study aimed to assess the feasibility and preliminary findings of a web-based cognitive behavioral therapy–based internet intervention, with and without human milk feeding education and support, to prevent perinatal depression and promote human milk feeding in Black mothers. Methods Participants were Black-identifying individuals between 20 and 28 weeks of pregnancy with human milk feeding intention and mild to moderate depressive symptoms (Patient Health Questionnaire scores 5-14). Participants were randomized to either Sunnyside, a 6-week cognitive behavioral therapy–based web-based intervention, or Sunnyside Plus, which included additional education and support to promote human milk feeding. Assessments occurred at baseline, third trimester (end of antenatal treatment), 6 weeks postpartum (end of postpartum treatment), and 12 weeks postpartum. The primary focus of this randomized pilot trial was the feasibility and preliminary outcomes of mental health and human milk feeding. Results A total of 22 tertiary-educated participants were randomized. The mean number of log-ins was 7.3 (SD 5.3) for Sunnyside and 13.8 (SD 10.5) for Sunnyside Plus. Scores of depression and anxiety measures remained below the clinical threshold for referral to treatment in both groups. All the participants initiated human milk feeding (18/18, 100%). Most participants reported at least some human milk feeding at both 6 and 12 weeks postpartum (6/7, 86%; 11/11, 100%, or 10/10, 100%, for Sunnyside and Sunnyside Plus, respectively). Conclusions The results suggest that tertiary-educated Black mothers at risk for perinatal depression and who intended to human milk feed were receptive to and satisfied with a web-based cognitive behavioral therapy–based internet intervention, with and without human milk feeding education and support. Preliminary findings indicate that both Sunnyside and Sunnyside Plus interventions have the potential to affect symptoms of depression, anxiety, and human milk feeding outcomes. Trial Registration ClinicalTrials.gov NCT04128202; https://www.clinicaltrials.gov/ct2/show/NCT04128202

The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.
The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scientific societies endorsing the checklist.
As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Mandatory reporting items are marked with a red *. In the textboxes, either copy & paste the relevant sections from your manuscript into this form -please include any quotes from your manuscript in QUOTATION MARKS, or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study. yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes inconclusive: more research is needed Other: not submitted yet -in early draft status not submitted yet -in late draft status, just before submission submitted to a journal but not reviewed yet submitted to a journal and after receiving initial reviewer comments submitted to a journal and accepted, but not published yet If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) T   1  a  )  T  I  T  L  E  :  I  d  e  n  t  i  f  i  c  a  t  i  o  n  a  s  a  r  a  n  d  o  m  i  z  e  d  t  r  i  a  l  i  n  t  h  e  t  i  t  l  Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.  T  R  A  C  T  :  S  t  r  u  c  t  u  r  e  d  s  u  m  m  a  r  y  o  f  t  r  i  a  l  d  e  s  i  g  n  ,  m  e  t  h  o  d  s  ,  r  e  s  u  l  t  s  ,  a  n  d  c  o  n  c  l  u  s  i  o  n  s   N  P  T  e  x  t  e  n  s  i  o  n  :  D  e  s  c  r  i  p  t  i  o  n  o  f  e  x  p  e  r  i  m  e  n  t  a  l  t  r  e  a  t  m  e  n  t  ,  c  o  m  p  a  r  a  t  o  r  ,  c  a  r  e  p  r  o  v  i  d  e  r  s  ,  c  e  n  t  e  r  s  ,  a  n  d  b  l  i  n  d  i  n  g  s  t  a  t  u  s  . subitem not at all important a  t  u  r  e  s  /  f  u  n  c  t  i  o  n  a  l  i  t  i  e  s  /  c  o  m  p  o  n  e  n  t  s  o  f  t  h  e  i  n  t  e  r  v  e  n  t  i  o  n  a  n  d  c  o  m  p  a  r  a  t  o  r  i  n  t  h  e  M  E  T  H  O  D  S  s  e  c  t  i  o  n  o  f  t  h  e  A  B  S  T  R  A  C  T Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Participants were recruited online. All assessments were either self report and online. Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A total of 22 tertiary-educated participants were randomized. The mean number of log-ins was 7.3 (SD 5.3) for Sunnyside and 13.8 (SD 10.5) for Sunnyside Plus." subitem not at all important Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The results suggest that tertiary-educated Black mothers at risk for perinatal depression and who intended to human milk feed were receptive to and satisfied with a web-based cognitive behavioral therapy-based internet intervention, with and without human milk feeding education and support." subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Inclusion criteria were as follows: (1) pregnant and between 20 and 28 weeks of gestation, (2) aged ≥18 years, (3) Black or African American, (4) intending to HM-feed their child, (5) self-reporting mild to moderate depressive symptoms (Patient Health Questionnaire [PHQ]-8 score of 5-14), (6) access to a broadband internet connection, and (7) proficiency in the English language. Exclusion criteria were as follows: (1) pregnant with multiples; (2) visual, hearing, voice, or motor impairment that would prevent completion of the study procedures; (3) diagnosed with a major depressive episode, psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder, or other diagnoses for which participation in this trial was either inappropriate or dangerous based on self-report; or (4) currently receiving treatment (medication or psychotherapy) and having an intention to resume antidepressant medication after birth (ie, those who discontinued their medication during pregnancy)." Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Computer / internet literacy was not assessed. Participants were recruited via online methods so literacy was assumed.
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Data was collected online, via video call, or via text message.
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Following consent, qualifying individuals were immediately directed to complete the baseline assessment surveys that were provided via a REDCap (Research Electronic Data Capture; Vanderbilt University) link; study data were collected and managed using REDCap electronic data capture tools hosted by the UIC [35,36]." "Follow-up assessments using REDCap took place following the completion of 6 weeks of web-based lessons during pregnancy (third trimester) and at 6 and 12 weeks postpartum. A brief assessment of HM feeding continuation and exclusivity (yes or no reply) was performed on a weekly basis via SMS text messaging (SimpleTexting [38]) from 1 to 6 weeks postpartum." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The Sunnyside intervention is a web-based intervention (a website with didactic material and tools) targeting skills to manage mood during and after pregnancy [33]. Sunnyside comprises 6 weeks of web-based lessons during pregnancy and web-based booster sessions at 2, 4, and 6 weeks postpartum. The intervention website was based on CBT and interpersonal therapy principles and comprised 12 learning modules covering basic skills (eg, behavioral activation and cognitive restructuring). Tools to assist in learning and implementing skills were associated with each learning module. The Feel Tool (ie, mood rating and feelings entry) encouraged participants to rate their mood each time they visited the site to obtain a better sense of their day-to-day feelings. The Think Tool (ie, thought record) was used to track one's thoughts and discern between helpful and harmful thinking. Participants tracked their daily behaviors, identified patterns, and planned future positive activities using the Do Tool (ie, activity scheduling or monitoring and goal setting).
In this study, participants were given unlimited access to the web intervention content that comprised lessons and tools and were encouraged to use the site at least twice weekly as new modules become available (every 3-4 days). The web-based lessons that were to be completed during pregnancy required approximately 40 to 60 minutes per week for 6 weeks. The web-based lessons completed during the first 6 weeks postpartum required approximately 10 to 20 minutes per week for 6 weeks." "Sunnyside Plus is built upon Sunnyside but also includes additional education and support to promote HM feeding. Education and skill promotion for HM feeding was provided during the 6 weeks of webbased lessons during pregnancy and then continued through 6 weeks postpartum. This postpartum support involved weekly web-based lessons, text support messages, and video support calls with a lactation specialist. The research team requested that at least 2 lactation support calls take place; however, beyond that, support was provided on an asneeded basis determined by the participant. Importantly, the participants had the option to choose who provided lactation support from a racially diverse team. Text support messages were sent using SimpleTexting [38], a user-friendly text-marketing software. Frequency of messages tapered from 3 to 1 message per week during the first 6 weeks postpartum. The SMS text message content included HM feeding encouragement and a reminder of the webbased lactation support." subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study New lessons were released twice per week. Participants were encouraged to come back for those lessons as desired.

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Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The research team requested that at least 2 lactation support calls take place; however, beyond that, support was provided on an as-needed basis determined by the participant. Importantly, the participants had the option to choose who provided lactation support from a racially diverse team." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The primary focus of this randomized pilot trial was feasibility (adherence to and satisfaction with the intervention) and preliminary outcomes on depression and anxiety symptom severity and HM feeding initiation, continuation, and exclusivity. Participants' sociodemographic data, parity, pregnancy-related variables, HM feeding history, mental health history, and birth-related variables were also measured." "Follow-up assessments using REDCap took place following the completion of 6 weeks of web-based lessons during pregnancy (third trimester) and at 6 and 12 weeks postpartum."

5
subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The REDCap randomization mechanism was used.
Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Significance testing for within-and between-group differences in mental health and HM feeding outcomes were assessed; however, this feasibility study was not powered for these types of analyses; therefore, our data are largely presented descriptively. These results should be interpreted with caution because of the small sample size." Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4] Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Qualifying individuals provided electronic consent to participate. All procedures were approved by the institutional review board at the University of Illinois Chicago (UIC)." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A total of 22 tertiary-educated Black pregnant individuals in their second trimester (mean EGA 22.6 [SD 2.5] weeks) participated in this US-based study." "Approximately 78% (7/9) of Sunnyside participants and 77% (10/13) of Sunnyside Plus participants completed the study through 12 weeks postpartum. Approximately 9% (2/22) of participants (1 from each intervention group) withdrew from the study after the baseline assessment. One of the Sunnyside participants did not complete the third trimester follow-up assessment but continued with the study. One of the participants in the Sunnyside Plus group did not engage in the web-based intervention or complete the assessments and was therefore withdrawn by the research team after the baseline assessment. Approximately 9% (2/22) of additional participants (1 from each intervention group) were considered lost to follow-up during the postpartum period; their mood scores did not differ from those who completed the study." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Approximately 78% (7/9) of Sunnyside participants and 77% (10/13) of Sunnyside Plus participants completed the study through 12 weeks postpartum. Approximately 9% (2/22) of participants (1 from each intervention group) withdrew from the study after the baseline assessment. One of the Sunnyside participants did not complete the third trimester followup assessment but continued with the study. One of the participants in the Sunnyside Plus group did not engage in the web-based intervention or complete the assessments and was therefore withdrawn by the research team after the baseline assessment. Approximately 9% (2/22) of additional participants (1 from each intervention group) were considered lost to follow-up during the postpartum period; their mood scores did not differ from those who completed the study." subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The trial did not end / was not stopped early.
subitem not at all important Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention. In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The mean number of log-ins across the 6-week intervention plus booster sessions was 7.3 (SD 5.3) for Sunnyside and 13.8 (SD 10.5) for Sunnyside Plus. Within the Sunnyside group, the average number of lessons accessed during pregnancy (from a total of 13) was 10.1 (SD 3.5) and during postpartum (from a total of 3) was 1.6 (SD 1.3). Within the Sunnyside Plus group, the average number of lessons accessed during pregnancy (from a total of 13) was 9.7 (SD 4.1) and during postpartum (from a total of 9) was 2.6 (SD 3.3). Approximately 67% (6/9) of Sunnyside participants and 58% (7/12) of Sunnyside Plus participants completed at least 50% of the available lessons. The average number of tools used was 11 (SD 6.6) for Sunnyside and 25. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study D  I  S  C  U  S  S  I  O  N   2  2  )  I  n  t  e  r  p  r  e  t  a  t  i  o  n  c  o  n  s  i  s  t  e  n  t  w  i  t  h  r  e  s  u  l  t  s  ,  b  a  l  a  n  c  i  n  g  b  e  n  e  f  i  t  s  a  n  d  h  a  r  Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This study describes the feasibility and preliminary findings of a novel CBT-based internet intervention to prevent perinatal depression and promote HM feeding in Black mothers with mild to moderate depressive symptoms and intention to HM-feed. Although both active treatment groups aimed to target skills to manage mood, the newly developed Sunnyside Plus intervention used evidence-based practices to promote and actively support the HM feeding." "The results of this study suggest that tertiary-educated Black mothers at risk for perinatal depression and who intended to HM-feed were receptive to, engaged with, and satisfied with a web-based CBT-based internet intervention, with and without HM feeding education and support, spanning from midpregnancy through 6 weeks postpartum.
Preliminary findings indicate that both Sunnyside and Sunnyside Plus interventions have the potential to affect symptoms of depression, anxiety, and HM feeding outcomes." subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This study had several limitations. Although the recruitment response was high, with an average of approximately 17 respondents each day during the 3-month recruitment period, the use of a convenient internet sample may have led to a bias toward higher education levels. In addition, our recruitment method through Ovia Health might not have been the best route, given the characteristics of those using the platform, and future projects should consider other recruitment routes. The major factors for exclusion were race and EGA. Future recruitment efforts should target internet-based applications used by those who identify as Black or African American. In addition, a system that allows for future rescreening might capture those who meet all inclusion criteria, except for the current EGA. As a small pilot study, this trial was not powered to reliably detect small significant differences or associations. The results should be interpreted with caution, and a larger trial is needed to verify these outcomes. Furthermore, the primary outcome data were based on self-report assessments, which may introduce recall bias. Finally, with no true control group, we relied on outside data to compare the rates of mental health and HM feeding outcomes  T  o  g  e  n  e  r  a  t  e  a  r  e  c  o  r  d  t  h  a  t  y  o  u  f  i  l  l  e  d  i  n  t  h  i  s  f  o  r  m  ,  w  e  r  e  c  o  m  m  e  n  d  t  o  g  e  n  e  r  a  t  e  a  P  D  F  o  f  t  h  i  s  p  a  g  e  (  o  n  a  M  a  c  ,  s  i  m  p  l  y  s  e  l  e  c  t  "  p  r  i  n  t  "  a  n  d  t  h  e  n  s  e  l  e  c  t  "  p  r  i  n  t  a  s  P  D  F  "  )  b  e  f  o  r  e  y  o  u  s  u  b  m  i  t  i  t  .   W  h  e  n  y  o  u  s  u  b  m  i  t  y  o  u  r  (  r  e  v  i  s  e  d  )  p  a  p  e  r  t  o  J  M  I  R  ,  p  l  e  a  s  e  u  p  l  o  a  d  t  h  e  P  D  F  a  s  s  u  p  p  l  e  m  e  n  t  a  r  y  f  i  l  e  .   D  o  n  '  t  w  o  r  r  y  i  f  s  o  m  e  t  e  x  t  i  n  t  h  e  t  e  x  t  b  o  x  e  s  i  s  c  u  t  o  f  f  ,  a  s  w  e  s  t  i  l  l  h  a  v  e  t  h  e  c  o  m  p  l  e  t  e  i  n  f  o  r  m  a  t  i  o  n  i  n  o  u  r  d  a