NCT02958475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

September 25, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

2.8 years

First QC Date

October 27, 2016

Last Update Submit

February 23, 2021

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in Breastfeeding Self-Efficacy Scale (BSES)

    Baseline, 3 and 6 months

  • Change in Iowa Infant Feeding Attitudes Scale (IIFAS)

    Baseline, 3 and 6 months

  • Change in Infant Feeding Intentions Scale (IFIS)

    Baseline, 3 and 6 months

  • Change in Infant Feeding Practices Survey II (IFPS-II)

    Baseline, 3 and 6 months

  • Change in Social Support Questionnaire (SSQ6)

    Baseline, 3 and 6 months

  • +2 more secondary outcomes

Study Arms (3)

Attention Control

EXPERIMENTAL

Participants in control arm will receive normal standard messages about infant injury prevention.

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.

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.

Behavioral: Breastfeeding messages

Interventions

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 plus Social Support
Breastfeeding messagesBEHAVIORAL

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.

Breastfeeding Messages onlyBreastfeeding Messages plus Social Support
Injury Prevention MessagesBEHAVIORAL

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

Attention Control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Decisionally challenged

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (12)

  • 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.

    PMID: 24595703BACKGROUND

  • 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.

    PMID: 24320091BACKGROUND

  • Jansson 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.

    PMID: 26121013BACKGROUND

  • Neifert 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.

    PMID: 23178062BACKGROUND

  • Neville 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.

    PMID: 22752723BACKGROUND

  • Bunik 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.

    PMID: 20129478BACKGROUND

  • Bunik 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.

    PMID: 19243262BACKGROUND

  • Bunik 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.

    PMID: 17661603BACKGROUND

  • Dennis 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.

    PMID: 14649593BACKGROUND

  • Fein 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.

    PMID: 18829837BACKGROUND

  • Noel-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.

    PMID: 22889093BACKGROUND

  • Nommsen-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.

    PMID: 18473131BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Maya Bunik, MD, MPH

    Colorado School of Public Health

    PRINCIPAL INVESTIGATOR

  • Jennifer Leiferman, PhD

    Colorado School of Public Health

    PRINCIPAL INVESTIGATOR

  • Sheana Bull, PhD MPH

    Colorado School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 8, 2016

Study Start

September 25, 2017

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

February 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)