THIS-WIC Vermont Breastfeeding Education Application Feasibility Study

Breast Feeding Clinical Trial

Official title:

THIS-WIC Vermont Breastfeeding Education Application Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967234
• Other study ID #: IRB # 308
• Status: Recruiting
• Phase: N/A
• Start date: December 26, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Tufts University
• Contact: Catherine Wright, MS
• Phone: 617-636-0436
• Email: catherine.wright[@]tufts.edu
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 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: -

Related Conditions & MeSH terms

• Breast Feeding
• Telehealth

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, U.S. Department of Agriculture, 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

External Links

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