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Completed

NCT Number: NCT02958475

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social Support Group (Facebook)

Behavioral

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.

Breastfeeding messages

Behavioral

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.

Injury Prevention Messages

Behavioral

The Mother's Milk Messaging app will provide participants in the control group with genetic injury prevention message.

Primary outcomes

  1. Change in Breastfeeding exclusivity

    Time frame: Baseline, 3 and 6 months

    Percent of exclusive feeds as a measured in the past 24 hrs (e.g. 80% breastmilk)

Secondary outcomes

  1. Change in Breastfeeding Self-Efficacy Scale (BSES)

    Time frame: Baseline, 3 and 6 months

    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.

  2. Change in Iowa Infant Feeding Attitudes Scale (IIFAS)

    Time frame: Baseline, 3 and 6 months

    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.

  3. Change in Infant Feeding Intentions Scale (IFIS)

    Time frame: Baseline, 3 and 6 months

    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).

  4. Change in Infant Feeding Practices Survey II (IFPS-II)

    Time frame: Baseline, 3 and 6 months

    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.

  5. Change in Social Support Questionnaire (SSQ6)

    Time frame: Baseline, 3 and 6 months

    The following questions ask about people in participant's life who provide them with help or support related to breastfeeding (family, friends, community).

  6. Change in Perceived Breastfeeding Support Assessment Tool (PBSAT)

    Time frame: Baseline, 3 and 6 months

    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.

  7. The Bidirectional Acculturation Scale for Hispanic (BAS)

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • W.K. Kellogg Foundation

Registry information

Acronym: MMM

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 8, 2016
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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