NCT06790654

Brief Summary

The goal of this clinical trial is to evaluate whether a text-based motivational interviewing (MI) intervention can increase exclusive breastfeeding rates and breastfeeding self-efficacy in mothers of healthy full-term infants. This study focuses on addressing breastfeeding barriers, particularly among mothers in underserved and rural populations. The main questions it aims to answer are:

  • Does a text-based MI intervention improve exclusive breastfeeding rates at two, four, and six weeks postpartum?
  • Does the intervention increase maternal breastfeeding self-efficacy during the same period? Researchers will compare the outcomes of mothers receiving the text-based MI intervention to standard breastfeeding support to assess its feasibility, acceptability, and initial effectiveness. Participants will:
  • Receive weekly personalized motivational text messages for six weeks postpartum.
  • Engage in interactive exchanges with MI-trained interviewers addressing breastfeeding challenges.
  • Complete surveys at baseline, mid-intervention, and post-intervention to assess breastfeeding behaviors and self-efficacy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 13, 2025

Last Update Submit

January 17, 2025

Conditions

Keywords

breastfeedingmotivational interviewing

Outcome Measures

Primary Outcomes (5)

  • Enrollment Number

    As a pilot measure of study feasibility, the final sample of participants will be compared against the target sample size of 30.

    End of study (six weeks)

  • Retention

    Retention will be calculated as the percentage of participants who complete the study out of those enrolled.

    End of study (six weeks)

  • Adherence

    Adherence (consistency of engagement with the text messages) will be measured as the share of interview sessions in which participants' respond to at least one motivational interviewing prompt.

    End of study (six weeks)

  • Acceptability

    Acceptability will be assessed using an measure of participant satisfaction with the program. This measure is a 5-item scale covering overall experience, clarity of text messages, helpfulness of guidance, influence on breastfeeding practices, and likelihood of recommending the program to others. Each item will be rated on a 5-point Likert scale ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"). Scores will be summed to produce a total satisfaction score, ranging from 5 to 25, with higher scores reflecting greater satisfaction.

    End of study (6 weeks)

  • Exclusive breastfeeding rates

    Exclusive breastfeeding status will be self-reported by participants.

    Weeks 3 and 6 of the intervention.

Secondary Outcomes (2)

  • Mixed-breastfeeding rates

    Weeks 3 and 6 of the intervention.

  • Breastfeeding Self-Efficacy

    Enrollment, week 3, and week 6.

Study Arms (1)

Motivational interviewing

EXPERIMENTAL

All participants will receive the intervention which consists of 6 weeks of text-based motivational interviewing targeted at addressing barriers to exclusive breastfeeding.

Behavioral: Text-message based motivational interviewing

Interventions

Participants will receive weekly text messages during the pilot study period, initiated and managed by MItrained interviewers. Each text message exchange will begin with a short, MI-consistent prompt developed with input from focus groups of mothers who have previously breastfed. These prompts will address common breastfeeding barriers. Following the initial prompt, MI-trained trainers will engage with participants through text exchanges that utilize the core MI OARS skills (open-ended questions, affirmations, reflections, or summaries) to facilitate change talk.

Motivational interviewing

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers who have given birth to a healthy full-term infant, intend to breastfeed, and possess a mobile device capable of receiving texts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Central Study Contacts

Benjamin H Walker, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 24, 2025

Study Start

March 1, 2025

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

January 24, 2025

Record last verified: 2025-01