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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05967234
Other study ID # IRB # 308
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 26, 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 116
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: - 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Telehealth solution
Telehealth solution offered for breastfeeding education.

Locations

Country Name City State
United States Tufts University Boston Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Tufts University RTI International, United States Department of Agriculture (USDA), Vermont WIC

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 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 Frequency of use of the telehealth solution 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
Secondary Intent to breastfeed 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
Secondary Breastfeeding duration 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
Secondary Attitudes to breastfeeding 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
Secondary Barriers encountered in use of the telehealth solution and breastfeeding 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
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