Telehealth Intervention Strategies for WIC (THIS-WIC)- Michigan

May 29, 2024 updated by: Erin Hennessy, Tufts University

With funding through the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC), Michigan's (MI) WIC department will pilot telehealth opportunities as a means of delivering services to WIC Clients. This video conferencing pilot looks to improve and/or remove barriers. Implementing a pilot program in select local agencies to utilize technology would allow clients to connect with a WIC Registered Dietitian (RD) or an International Board-Certified Lactation Consultant (IBCLC). Videoconferencing could open new opportunities for leveraging the extensive expertise of the nutrition and lactation workforce in WIC agencies to address rural and remote locations and travel considerations.

The purpose of this study will be to evaluate the effectiveness of this telehealth solution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Michigan WIC Agency will pilot telehealth opportunities as a means of delivering services to WIC Clients.This video conferencing pilot looks to improve and/or remove barriers such as negative clinic experiences (long wait times or poor customer service), lost time from work (creating job risk and lost wages), inconvenient WIC clinic locations and appointment times, and lack of transportation. Implementing a pilot program in select local agencies to utilize technology would allow clients to connect with a WIC Registered Dietitian (RD) or an International Board-Certified Lactation Consultant (IBCLC). Videoconferencing could open new opportunities for leveraging the extensive expertise of the nutrition and lactation workforce in WIC agencies to address rural and remote locations and travel considerations. Additional urban locations, where clients lack transportation or use of public transportation presents a barrier to traveling to subsequent WIC appointments, will also be included in the pilot. Local agencies in rural and urban areas with similar caseloads will serve as controls to compare outcomes between offering telehealth and conducting IBCLC and RD appointments in person.

The purpose of this study is to evaluate the effectiveness of this telehealth solution by having clients complete surveys on their comfortability using telehealth and their satisfaction with the telehealth appointment. Additionally, 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)

386

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

  • United States
    • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women
  • Breastfeeding women
  • postpartum women with children in the age range of 0 to 5 years

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual care
Experimental: Telehealth solution
Telehealth solution offered
Behavioral: Telehealth solution
Video conferencing

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 18 months
WIC clients satisfaction with nutrition education and breastfeeding support offered via the telehealth solution compared to usual care. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
During the study period, approximately 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding duration
Time Frame: During the study period, approximately 18 months
Duration of breastfeeding in clients offered the telehealth solution compared to usual care. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
During the study period, approximately 18 months
Attendance at scheduled appointments
Time Frame: During the study period, approximately 18 months
WIC clients attendance at appointments when offered the telehealth solution compared to usual care. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
During the study period, approximately 18 months
Dietary intake
Time Frame: During the study period, approximately 18 months
Impact of the telehealth solution compared to usual care on dietary intake. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
During the study period, approximately 18 months
Attitudes to breastfeeding and nutrition education
Time Frame: During the study period, approximately 18 months
Impact of the telehealth solution compared to usual care on WIC clients' attitudes to breastfeeding and nutrition education. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
During the study period, approximately 18 months
Barriers encountered in obtaining nutrition education and breastfeeding support
Time Frame: During the study period, approximately 18 months
Impact of the telehealth solution compared to usual care on barriers encountered by WIC clients in obtaining nutrition education and breastfeeding support. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
During the study period, approximately 18 months

Collaborators and Investigators

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

Sponsor

Tufts University

Collaborators

United States Department of Agriculture (USDA)
RTI International
State of Michigan WIC Program

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.

Helpful Links

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 10, 2021

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 28, 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

Keywords

Other Study ID Numbers

  • 202112-01-EA / STUDY00002536

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.

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