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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05854199
Other study ID # STUDY00002935
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 16, 2022
Est. completion date November 30, 2023

Study information

Verified date May 2024
Source Tufts University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 892
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Telehealth solution
Telehealth nutrition education platform

Locations

Country Name City State
United States Tufts University Boston Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Tufts University North Carolina Department of Health and Human Services, RTI International, United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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