Evaluating Telehealth Solutions in WIC: Wisconsin WIC Clients

February 2, 2023 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) project, Wisconsin's (WI) WIC department will be implementing a new, customized, mobile-friendly nutrition education platform called ONE (Online Nutrition Education) in WI's WIC program. The purpose of this study is to evaluate the impact of the ONE platform. The evaluation will focus on WIC clients as the study population. The Wisconsin WIC department would be implementing this education platform, regardless of the evaluation research. The Wisconsin WIC department is responsible for implementing this new intervention, while the Tufts University research team is responsible for the evaluation of this platform through surveys and analysis of administrative data.

An online survey will be used to gauge WIC clients' satisfaction with ONE, and the impact of the telehealth solution compared to usual care on breastfeed duration, dietary intake, attendance at scheduled appointments, attitudes to breastfeeding and nutrition education, and barriers encountered. Survey data will be combined with previously collected data on clients and their families from the WI Management Information Systems (MIS), and aggregate level data from the ONE telehealth solution about ONE utilization.

Study Overview

Status

Recruiting

Conditions

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 WI 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 WI's telehealth solution to inform how the ONE platform supports WIC services compared to usual in-person care. ONE is a mobile-optimized website, meaning that it functions as an app without requiring the amount of memory and data that apps use. WIC clients can experience the ONE platform in either English or Spanish. Evaluation findings will inform stakeholders about the platform's benefits and how viable it is to sustain and adapt ONE more widely.

Surveys will be conducted online via the Alchemer survey software platform for intervention and control sites.

Study Type

Interventional

Enrollment (Anticipated)

11000

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
        • Recruiting
        • 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

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant women
  • postpartum women
  • parent/guardian of a participating infant or child in the WIC program

Study participants will be clients at local WIC agency sites where either the telehealth solution is offered or where only usual care is available (control).

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Telehealth solution
Telehealth solution offered
Behavioral: Telehealth solution
Mobile-friendly nutrition education platform
NO_INTERVENTION: Usual care
Control

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 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
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. 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
Wisconsin Department of Health and Family Services

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)

January 12, 2022

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

August 1, 2023

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

February 2, 2023

First Posted (ESTIMATE)

February 14, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00002199

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe