BreastfeedingMMMNCT02958475
Mother's Milk Messaging: Evaluation of a Bilingual Application (APP) to Support Initiation and Exclusive Breastfeeding in New Mothers
A study testing Social Support Group (Facebook), Breastfeeding messages and Injury Prevention Messages in people with Breastfeeding, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Social Support Group (Facebook), Breastfeeding messages and Injury Prevention Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2017to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Decisionally challenged
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breastfeeding
- Being tested
- Social Support Group (Facebook), Breastfeeding messages, Injury Prevention Messages
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Support Group (Facebook)Behavioural
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 messagesBehavioural
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 MessagesBehavioural
The Mother's Milk Messaging app will provide participants in the control group with genetic injury prevention message.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control | Experimental | Participants in control arm will receive normal standard messages about infant injury prevention. Receives: Behavioral: Injury Prevention Messages |
| Breastfeeding Messages plus Social Support | Active comparator | 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. Receives: Behavioral: Social Support Group (Facebook); Behavioral: Breastfeeding messages |
| Breastfeeding Messages only | Active comparator | 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. Receives: Behavioral: Breastfeeding messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Breastfeeding exclusivity
Percent of exclusive feeds as a measured in the past 24 hrs (e.g. 80% breastmilk)
Measured: Baseline, 3 and 6 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start25 Sep 2017
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- W.K. Kellogg Foundation
- Responsible party
- Sponsor
- Investigators
- Maya Bunik, MD, MPH, Principal investigator, Colorado School of Public HealthJennifer Leiferman, PhD, Principal investigator, Colorado School of Public HealthSheana Bull, PhD MPH, Principal investigator, Colorado School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958475
- Sponsor's protocol ID
- 16-1740
- Acronym
- MMM
- Status last verified
- Feb 2021
- First submitted
- 27 Oct 2016
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bunik M, Dunn DM, Watkins L, Talmi A. Trifecta approach to breastfeeding: clinical care in the integrated mental health model. J Hum Lact. 2014 May;30(2):143-7. doi: 10.1177/0890334414523333. Epub 2014 Mar 4.
PubMed 24595703Holmes 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.
PubMed 24320091Jansson LM, Bunik M, Bogen DL. Lactation and the Marijuana-Using Mother. Breastfeed Med. 2015 Jul-Aug;10(6):342-3. doi: 10.1089/bfm.2015.0067. Epub 2015 Jun 29. No abstract available.
PubMed 26121013Neifert M, Bunik M. Overcoming clinical barriers to exclusive breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):115-45. doi: 10.1016/j.pcl.2012.10.001.
PubMed 23178062Neville MC, Anderson SM, McManaman JL, Badger TM, Bunik M, Contractor N, Crume T, Dabelea D, Donovan SM, Forman N, Frank DN, Friedman JE, German JB, Goldman A, Hadsell D, Hambidge M, Hinde K, Horseman ND, Hovey RC, Janoff E, Krebs NF, Lebrilla CB, Lemay DG, MacLean PS, Meier P, Morrow AL, Neu J, Nommsen-Rivers LA, Raiten DJ, Rijnkels M, Seewaldt V, Shur BD, VanHouten J, Williamson P. Lactation and neonatal nutrition: defining and refining the critical questions. J Mammary Gland Biol Neoplasia. 2012 Jun;17(2):167-88. doi: 10.1007/s10911-012-9261-5. Epub 2012 Jul 1.
PubMed 22752723Bunik M, Shobe P, O'Connor ME, Beaty B, Langendoerfer S, Crane L, Kempe A. Are 2 weeks of daily breastfeeding support insufficient to overcome the influences of formula? Acad Pediatr. 2010 Jan-Feb;10(1):21-8. doi: 10.1016/j.acap.2009.09.014.
PubMed 20129478Bunik M, Krebs NF, Beaty B, McClatchey M, Olds DL. Breastfeeding and WIC enrollment in the Nurse Family Partnership Program. Breastfeed Med. 2009 Sep;4(3):145-9. doi: 10.1089/bfm.2008.0140.
PubMed 19243262Bunik M, Clark L, Zimmer LM, Jimenez LM, O'Connor ME, Crane LA, Kempe A. Early infant feeding decisions in low-income Latinas. Breastfeed Med. 2006 Winter;1(4):225-35. doi: 10.1089/bfm.2006.1.225.
PubMed 17661603Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
PubMed 14649593Fein SB, Labiner-Wolfe J, Scanlon KS, Grummer-Strawn LM. Selected complementary feeding practices and their association with maternal education. Pediatrics. 2008 Oct;122 Suppl 2:S91-7. doi: 10.1542/peds.2008-1315l.
PubMed 18829837Noel-Weiss J, Boersma S, Kujawa-Myles S. Questioning current definitions for breastfeeding research. Int Breastfeed J. 2012 Aug 13;7(1):9. doi: 10.1186/1746-4358-7-9.
PubMed 22889093Nommsen-Rivers LA, Dewey KG. Development and validation of the infant feeding intentions scale. Matern Child Health J. 2009 May;13(3):334-42. doi: 10.1007/s10995-008-0356-y. Epub 2008 May 13.
PubMed 18473131
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mother's Milk Messaging: Evaluation of a Bilingual Application (APP) to Support Initiation and Exclusive Breastfeeding in New Mothers
- ClinicalTrials.gov ID
- NCT02958475
- Acronym / sponsor ID
- MMM / 16-1740
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- W.K. Kellogg Foundation
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Attention Control | Experimental | Behavioral: Injury Prevention MessagesParticipants in control arm will receive normal standard messages about infant injury prevention. |
| Breastfeeding Messages plus Social Support | Active comparator | Behavioral: Social Support Group (Facebook), Behavioral: Breastfeeding messagesParticipant 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. |
| Breastfeeding Messages only | Active comparator | Behavioral: Breastfeeding messagesParticipant 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Decisionally challenged
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Support Group (Facebook)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. | Behavioural | Breastfeeding Messages plus Social Support |
| Breastfeeding messagesThe 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. | Behavioural | Breastfeeding Messages only, Breastfeeding Messages plus Social Support |
| Injury Prevention MessagesThe Mother's Milk Messaging app will provide participants in the control group with genetic injury prevention message. | Behavioural | Attention Control |
Primary outcome
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)
7 secondary outcomes
Change in Breastfeeding Self-Efficacy Scale (BSES)
Time frame: Baseline, 3 and 6 months
Change in Iowa Infant Feeding Attitudes Scale (IIFAS)
Time frame: Baseline, 3 and 6 months
Change in Infant Feeding Intentions Scale (IFIS)
Time frame: Baseline, 3 and 6 months
Change in Infant Feeding Practices Survey II (IFPS-II)
Time frame: Baseline, 3 and 6 months
Change in Social Support Questionnaire (SSQ6)
Time frame: Baseline, 3 and 6 months
Change in Perceived Breastfeeding Support Assessment Tool (PBSAT)
Time frame: Baseline, 3 and 6 months
The Bidirectional Acculturation Scale for Hispanic (BAS)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Background: PubMed 24595703Bunik M, Dunn DM, Watkins L, Talmi A. Trifecta approach to breastfeeding: clinical care in the integrated mental health model. J Hum Lact. 2014 May;30(2):143-7. doi: 10.1177/0890334414523333. Epub 2014 Mar 4.
- Background: PubMed 24320091Holmes 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.
- Background: PubMed 26121013Jansson LM, Bunik M, Bogen DL. Lactation and the Marijuana-Using Mother. Breastfeed Med. 2015 Jul-Aug;10(6):342-3. doi: 10.1089/bfm.2015.0067. Epub 2015 Jun 29. No abstract available.
- Background: PubMed 23178062Neifert M, Bunik M. Overcoming clinical barriers to exclusive breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):115-45. doi: 10.1016/j.pcl.2012.10.001.
- Background: PubMed 22752723Neville MC, Anderson SM, McManaman JL, Badger TM, Bunik M, Contractor N, Crume T, Dabelea D, Donovan SM, Forman N, Frank DN, Friedman JE, German JB, Goldman A, Hadsell D, Hambidge M, Hinde K, Horseman ND, Hovey RC, Janoff E, Krebs NF, Lebrilla CB, Lemay DG, MacLean PS, Meier P, Morrow AL, Neu J, Nommsen-Rivers LA, Raiten DJ, Rijnkels M, Seewaldt V, Shur BD, VanHouten J, Williamson P. Lactation and neonatal nutrition: defining and refining the critical questions. J Mammary Gland Biol Neoplasia. 2012 Jun;17(2):167-88. doi: 10.1007/s10911-012-9261-5. Epub 2012 Jul 1.
- Background: PubMed 20129478Bunik M, Shobe P, O'Connor ME, Beaty B, Langendoerfer S, Crane L, Kempe A. Are 2 weeks of daily breastfeeding support insufficient to overcome the influences of formula? Acad Pediatr. 2010 Jan-Feb;10(1):21-8. doi: 10.1016/j.acap.2009.09.014.
- Background: PubMed 19243262Bunik M, Krebs NF, Beaty B, McClatchey M, Olds DL. Breastfeeding and WIC enrollment in the Nurse Family Partnership Program. Breastfeed Med. 2009 Sep;4(3):145-9. doi: 10.1089/bfm.2008.0140.
- Background: PubMed 17661603Bunik M, Clark L, Zimmer LM, Jimenez LM, O'Connor ME, Crane LA, Kempe A. Early infant feeding decisions in low-income Latinas. Breastfeed Med. 2006 Winter;1(4):225-35. doi: 10.1089/bfm.2006.1.225.
- Background: PubMed 14649593Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
- Background: PubMed 18829837Fein SB, Labiner-Wolfe J, Scanlon KS, Grummer-Strawn LM. Selected complementary feeding practices and their association with maternal education. Pediatrics. 2008 Oct;122 Suppl 2:S91-7. doi: 10.1542/peds.2008-1315l.
- Background: PubMed 22889093Noel-Weiss J, Boersma S, Kujawa-Myles S. Questioning current definitions for breastfeeding research. Int Breastfeed J. 2012 Aug 13;7(1):9. doi: 10.1186/1746-4358-7-9.
- Background: PubMed 18473131Nommsen-Rivers LA, Dewey KG. Development and validation of the infant feeding intentions scale. Matern Child Health J. 2009 May;13(3):334-42. doi: 10.1007/s10995-008-0356-y. Epub 2008 May 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Bunik, MD, MPH principal investigator
Colorado School of Public Health
Jennifer Leiferman, PhD principal investigator
Colorado School of Public Health
Sheana Bull, PhD MPH principal investigator
Colorado School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Support Group (Facebook), Breastfeeding messages and Injury Prevention Messages in people with Breastfeeding, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Breastfeeding exclusivity (time frame: Baseline, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02958475, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.