Mother's Milk Messaging: Evaluation of a Bilingual Application (APP) to Support Initiation and Exclusive Breastfeeding in New Mothers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mother's Milk Messaging: Evaluation of a Bilingual Application (APP) to Support Initiation and Exclusive Breastfeeding in New Mothers

Conditions
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Breastfeeding

Intervention / Treatment
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* Behavioral: Social Support Group (Facebook)
* Behavioral: Breastfeeding messages
* Behavioral: Injury Prevention Messages


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attention Control<br>Participants in control arm will receive normal standard messages about infant injury prevention. | Behavioral: Injury Prevention Messages<br>* The Mother's Milk Messaging app will provide participants in the control group with genetic injury prevention message.<br>|
| Active Comparator: Breastfeeding Messages plus Social Support<br>Participant will receive between 5-7 text messages weekly through push notifications to their phone. 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. In addition they will be able to download the MMM app, which will store text messages received. Additionally, participants in this arm will be able to link within the app to a private Facebook page. Participants can access this page through their app or directly via Facebook where they can view, comment, and share in response to posts. 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. | Behavioral: Social Support Group (Facebook)<br>* 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.<br>Behavioral: Breastfeeding messages<br>* The Mother's Milk Messaging app gives participants access to text messages via push notification on the app, as well as 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.<br>|
| Active Comparator: Breastfeeding Messages only<br>Participant will receive between 5-7 text messages weekly through push notifications to their phone. 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. | Behavioral: Breastfeeding messages<br>* The Mother's Milk Messaging app gives participants access to text messages via push notification on the app, as well as 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Breastfeeding exclusivity | Percent of exclusive feeds as a measured in the past 24 hrs (e.g. 80% breastmilk) | Baseline, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Breastfeeding Self-Efficacy Scale (BSES) | Breastfeeding self-efficacy is very important variable in breastfeeding duration, as it predicts whether a mother chooses to breastfeed, how much effort she will put into it and how she will respond to breastfeeding related difficulties. Using the BSES Long form 33-item scale we will assess participants self-efficacy related to breastfeeding intention and duration. | Baseline, 3 and 6 months | 
| Change in Iowa Infant Feeding Attitudes Scale (IIFAS) | Assessing participants self-efficacy (confidence) toward infant feeding methods, The scale consists of 17 items, with items worded so that approximately half of the questions are favorable toward breast-feeding and the remaining questions favorable toward formula-feeding. These scores are then computed so that a high score reflects a preference for breast-feeding. | Baseline, 3 and 6 months | 
| Change in Infant Feeding Intentions Scale (IFIS) | To quantitatively assess strength of intentions to initiate breastfeeding and continue to provide breast milk as the sole source of milk throughout the first 6 months (as recommended by public health agencies). | Baseline, 3 and 6 months | 
| Change in Infant Feeding Practices Survey II (IFPS-II) | IFPS-II was a longitudinal study focusing on infant feeding practices throughout the first year of life and the diets of women in their 3rd trimester and at four months postpartum. Infant feeding behaviors include patterns of breastfeeding, formula feeding, solid food intake, and feeding other complementary foods and liquids. We will focus on assessing participants breastfeeding intention, attitudes and outcome expectancies. | Baseline, 3 and 6 months | 
| Change in Social Support Questionnaire (SSQ6) | The following questions ask about people in participant's life who provide them with help or support related to breastfeeding (family, friends, community). | Baseline, 3 and 6 months | 
| Change in Perceived Breastfeeding Support Assessment Tool (PBSAT) | A 29-item based two-dimensional tool that has acceptable psychometric properties, the PBSAT is context specific, comprehensive, and user-friendly, so it can be administered by health-care workers, employers, policy makers, and researchers to improve the quality of services of breast-feeding urban working mothers, and could ultimately improve child health. | Baseline, 3 and 6 months | 
| The Bidirectional Acculturation Scale for Hispanic (BAS) | The Bidirectional Acculturation Scale for Hispanic (BAS) measures acculturation to both Hispanic and non-Hispanic culture. The BAS includes 24 items measuring acculturation to Hispanic culture and 12 items that measure Hispanic or non-Hispanic acculturation are divided as Language Use, Linguistic Proficiency and Electronic Media. Participants rate their agreement with statement about the frequency of their language use and their proficiency using a 4-point Likert type format. | Baseline |