Clinical trial NCT02958475: Mother's Milk Messaging: Evaluation of a Bilingual Application (APP) to Support Initiation and Exclusive Breastfeeding in New Mothers
Official title: Mother's Milk Messaging: Evaluation of a Bilingual Application (APP) to Support Initiation and Exclusive Breastfeeding in New Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: W.K. Kellogg Foundation
First posted: 2016-11-08
Enrollment: 346
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is being conducted to evaluate the breastfeeding support program utilizing bilingual English-Spanish tailored text messages and online support to support exclusive and continuous breastfeeding for new mothers--comparing texting alone, texting with an online support group to those with usual care. The cost involved in moderating the online groups and providing bidirectional consultation when needed will be evaluated and qualitative feedback from a subset of mothers in both intervention groups will be evaluated to determine what was effective, as well as suggestions for improvement of the messaging program.

Detailed description: Women of child-bearing age are in the generation most likely to use texting to communicate, and most own a cellular phone, and that cell phones have been demonstrated to be efficacious in increasing Human Immunodeficiency Virus (HIV) medication compliance and smoking cessation, and in improving diabetes management, the investigators consider this may be a promising strategy to increase breastfeeding. The investigators developed theoretically-based text message content along with breast feeding informational and video content designed for delivery via closed private groups on social media based on formative work and then conducted a pilot study to text the effects of interactive messaging sent over a 12 week period (i.e. 6 weeks prior and after birth) that targeted barriers (e.g. insufficient milk, pain/sore nipples, breastfeeding in public, among others) on exclusivity and continuation of breastfeeding. The investigators innovative approach, called Mother's Milk Messaging (MMM) specifically targets low-income and minority mothers and has the potential to reach unprecedented numbers of mothers, to be standardized for later scalability, and to be cost-effective.

While Text4Baby texting application uses a similar approach, the text messages are not interactive and they do not address specific issues with breastfeeding. The device's social media content facilitates private, peer and expert support for breastfeeding in real time on a channel preferred by first time mothers.

Applying a theoretically-based framework, the investigators developed content stemming from Dr. Maya Bunik's previous published Breastfeeding Telephone Triage and Advice. Content was adapted for delivery via a mobile application (App) with attention to an Integrated Theory of mobile Health (mHealth) using best practices for app design for health promotion using social and mobile technology. The content was modified to facilitate engagement with content using technology, utilizing communication theories such as Gain and Loss Framing and Elaboration theory, and theories to support social networking and social support, along with behavioral health theories such as the Theory of Planned Behavior and Social Cognitive Theory.

The MMM app has three main elements: text messages via push notification are stored and searchable on the app, access to a breastfeeding social support group on Facebook, and access to videos and written material to facilitate knowledge acquisition and skills building. The text messages are targeted at specific theoretical constructs such as outcome expectations/attitudes, barrier self-efficacy, reinforcing a message using peripheral (expert) opinion, eliciting a sense of social currency or providing a cue-to-action. The breastfeeding social support group on Facebook will be moderated to facilitate posting of shared experiences. Short videos, photographs, and written blurbs on related topics are posted on the Facebook page to reinforce the messaging and content of the texts. After a successful pilot study of MMM the investigators are ready to test the benefits of supporting new mothers with breastfeeding using the investigators bilingual mobile phone application (app) and online support program.

Eligibility criteria: Inclusion Criteria:

* Women who are first time mothers
* Women ages 18-40
* Who can converse and write in English and/or Spanish
* Who reside in the U.S.
* Who are expecting a normal singleton birth
* Who are pregnant
* Have access to a computer connected to the Internet
* Have access to a mobile device that can receive text messages and access the Internet (smart phone)

Exclusion Criteria:

* Decisionally challenged

Primary outcomes:
measure: Change in Breastfeeding exclusivity
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
measure: Change in Breastfeeding Self-Efficacy Scale (BSES)
timeFrame: Baseline, 3 and 6 months
measure: Change in Iowa Infant Feeding Attitudes Scale (IIFAS)
timeFrame: Baseline, 3 and 6 months
measure: Change in Infant Feeding Intentions Scale (IFIS)
timeFrame: Baseline, 3 and 6 months
measure: Change in Infant Feeding Practices Survey II (IFPS-II)
timeFrame: Baseline, 3 and 6 months
measure: Change in Social Support Questionnaire (SSQ6)
timeFrame: Baseline, 3 and 6 months
measure: Change in Perceived Breastfeeding Support Assessment Tool (PBSAT)
timeFrame: Baseline, 3 and 6 months
measure: The Bidirectional Acculturation Scale for Hispanic (BAS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: Colorado School of Public Health
name: Maya Bunik, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Colorado School of Public Health
name: Jennifer Leiferman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Colorado School of Public Health
name: Sheana Bull, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Holmes AV, McLeod AY, Bunik M. ABM Clinical Protocol #5: Peripartum breastfeeding management for the healthy mother and infant at term, revision 2013. Breastfeed Med. 2013 Dec;8(6):469-73. doi: 10.1089/bfm.2013.9979.
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