THIS-WIC Telehealth Solutions: Evaluation With North Carolina WIC Clients

With funding through the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, North Carolina (NC) WIC department will be implementing new, nutrition education telehealth in NC's WIC program. The purpose of this study is to evaluate the impact of the telehealth platform. The evaluation will focus on NC WIC clients as the study population. The North Carolina WIC department would be implementing this education platform, regardless of the evaluation research. The North Carolina 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 the telehealth solution 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 NC Management Information Systems (MIS), and aggregate level data from the telehealth solution about utilization.

Study Overview

• Status: Recruiting
• Conditions: Telehealth; Dietary Intake; Nutrition Education; WIC
• Intervention / Treatment: Behavioral: Telehealth solution

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

• Study Type: Interventional
• Enrollment (Anticipated): 38600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Wright, MS; Phone Number: 617-636-0436; Email: catherine.wright@tufts.edu
• Study Contact Backup: Name: Shanti Sharma, PhD; Phone Number: 617-636-0312; Email: shanti.sharma@tufts.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts University
      • Contact: Catherine Wright, MS; Phone Number: 617-636-0436; Email: catherine.wright@tufts.edu
      • Contact: Shanti Sharma, PhD; Phone Number: 617-636-0312; Email: shanti.sharma@tufts.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth solution; Telehealth solution offered	Behavioral: Telehealth solution; Telehealth 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	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 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding duration	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 12 months
Attendance at scheduled appointments	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 12 months
Dietary intake	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 12 months
Attitudes to breastfeeding and nutrition education	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 12 months
Barriers encountered in obtaining nutrition education	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 12 months

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: RTI International; North Carolina Department of Health and Human Services; U.S. Department of Agriculture
• Investigators: Principal Investigator: Erin Hennessy, PhD, Tufts University

Publications and helpful links

Helpful Links

• Tufts Telehealth Intervention Strategies for WIC (THIS-WIC) website

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Telehealth; nutrition education; dietary intake; WIC
• Other Study ID Numbers: STUDY00002935

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