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Clinical Trials/NCT06790654
NCT06790654Not yet recruitingNot Applicable

Text-based Motivational Interviewing Intervention to Promote Exclusive Breastfeeding Rates

University of Mississippi Medical Center0 sites30 target enrollmentStarted: March 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Primary Endpoint
Enrollment Number

Study Overview

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.

Detailed Description

Overview This pilot study will develop and evaluate the feasibility and acceptability of a text-based motivational interviewing intervention to increase breastfeeding rates. Mother-infant dyads will be recruited from the University of Mississippi Medical Center full-term nursery. Tailored text messages will address breastfeeding barriers, informed by focus groups and an expert panel. We will assess adherence, satisfaction, and fidelity and explore initial changes in breastfeeding self-efficacy and breastfeeding rates at two, four, and six weeks to inform the development of a clinical trial.

Aim 1: To develop a text-based motivational interviewing (MI) intervention and procedures for delivery.

We will use focus groups to gather qualitative data on breastfeeding barriers and integrate feedback from these groups and experts to tailor messages that reflect parent needs. We will recruit 6-8 mothers through Health Moms Health Babies (MSDH), MOM. M.E. via Mental Health Mississippi, La Leche League of Metro Jackson, MS Breastfeeding Coalition Facebook group, and the EversCare Clinic (via UMMC). We will facilitate 2-3 focus group sessions, each lasting approximately 1.5 to 2 hours, using a semi-structured interview guide to explore participants' experiences and challenges with breastfeeding. This qualitative analysis will aim to identify common barriers to exclusive breastfeeding that can be addressed through the MI protocol. The sessions will be recorded, transcribed, and analyzed qualitative data to identify and categorize themes related to barriers to exclusive breastfeeding.

Next, we will engage experts in motivational interviewing, lactation, and neonatology to ensure the messaging strategy is appropriate, evidence-based, and effectively addresses barriers to breastfeeding. We will employ the Delphi Technique, involving multiple rounds of anonymous questionnaires distributed to a panel of experts. Experts will provide feedback on the MI-based text messages in each round, which will be summarized and shared with the panel before the next round. The iterative nature of the Delphi Technique will help achieve consensus on the most effective and culturally sensitive messages for our intervention.

Procedures for Delivery

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •Exclusion criteria include age < 18, contraindications to breastfeeding, substance use, or multiple gestation.

Arms & Interventions

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.

Intervention: Text-message based motivational interviewing (Behavioral)

Outcomes

Primary Outcomes

Enrollment Number

Time Frame: End of study (six weeks)

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

Retention

Time Frame: End of study (six weeks)

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

Adherence

Time Frame: End of study (six weeks)

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.

Acceptability

Time Frame: End of study (6 weeks)

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.

Exclusive breastfeeding rates

Time Frame: Weeks 3 and 6 of the intervention.

Exclusive breastfeeding status will be self-reported by participants.

Secondary Outcomes

  • Mixed-breastfeeding rates(Weeks 3 and 6 of the intervention.)
  • Breastfeeding Self-Efficacy(Enrollment, week 3, and week 6.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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