THIS-WIC Vermont Breastfeeding Education Application Feasibility Study

May 29, 2024 updated by: Erin Hennessy, Tufts University
With funding through USDA and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, the Vermont WIC department will be conducting a feasibility study of a mobile telehealth solution for breastfeeding education. The purpose of this study is to evaluate this telehealth solution. The research/evaluation involves completing online surveys and interviews. The evaluation will focus on participant satisfaction, usage of the telehealth solution, and use of information collected on WIC participant through the WIC management information system (MIS) and the telehealth platform. It is hypothesized that the telehealth solution will increase WIC participant's satisfaction with breastfeeding education.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Telehealth can reduce barriers and increase access to care, and it can be applied to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). WIC is a federal nutrition assistance program that helps low-income women with children up to age 5. There is a large volume of research that supports remote patient monitoring, and the most benefits are found when telehealth is used for communication and counseling. The USDA awarded Tufts University a grant to test and evaluate the use of telehealth innovations in the delivery of USDA's WIC program. Tufts University then offered the USDA/Tufts Telehealth Intervention Strategies for WIC (THIS-WIC) grant opportunity to WIC state agencies across the US. THIS-WIC selected 7 WIC State Agencies to receive grants, and the Vermont state agency is one recipient. The THIS-WIC team at Tufts University is leading the evaluation of these telehealth solutions in collaboration with funded WIC State Agencies.

THIS-WIC aims to generate evidence from Vermont's telehealth solution to inform how the telehealth platform supports WIC services . Evaluation findings will inform stakeholders about the platform's benefits and how viable it is to sustain and adapt more widely.

The purpose of this study is to evaluate the effectiveness of this telehealth solution by having clients complete surveys and interviews on their comfortability using telehealth and their satisfaction with the telehealth solution. Additionally, information about usage will be collected from the telehealth platform, and secondary demographic and other nutrition-related information about study participants is already collected in the MIS and will be utilized.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Speaks and reads English (as the telehealth solution is available in English)
  • Pregnant or postpartum
  • Has access to a smart phone or smart device (e.g. iPad or tablet)

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telehealth solution
Telehealth solution offered for breastfeeding education.
Telehealth solution offered for breastfeeding education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with the telehealth solution
Time Frame: During the study period, approximately 12 months
WIC clients satisfaction with breastfeeding education offered via the telehealth solution. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
During the study period, approximately 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of use of the telehealth solution
Time Frame: During the study period, approximately 12 months
The frequency with which WIC clients use the telehealth solution. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
During the study period, approximately 12 months
Intent to breastfeed
Time Frame: During the study period, approximately 12 months
WIC clients intent to breastfeed. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
During the study period, approximately 12 months
Breastfeeding duration
Time Frame: During the study period, approximately 12 months
Duration of breastfeeding in clients offered the telehealth solution. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
During the study period, approximately 12 months
Attitudes to breastfeeding
Time Frame: During the study period, approximately 12 months
Impact of the telehealth solution on WIC clients' attitudes to breastfeeding. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
During the study period, approximately 12 months
Barriers encountered in use of the telehealth solution and breastfeeding
Time Frame: During the study period, approximately 12 months
Barriers encountered by WIC clients in use of the telehealth solution and in breastfeeding. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
During the study period, approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Erin Hennessy, PhD, Tufts University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IRB # 308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Feeding

Clinical Trials on Telehealth solution

Subscribe