Telehealth Intervention Strategies for WIC (THIS-WIC)- Michigan

Breast Feeding Clinical Trial

Official title:

Telehealth Intervention Strategies for WIC (THIS-WIC)- Michigan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746741
• Other study ID #: 202112-01-EA / STUDY00002536
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: August 2023

Study information

• Verified date: February 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 the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC), Michigan's (MI) WIC department will pilot telehealth opportunities as a means of delivering services to WIC Clients. This video conferencing pilot looks to improve and/or remove barriers. Implementing a pilot program in select local agencies to utilize technology would allow clients to connect with a WIC Registered Dietitian (RD) or an International Board-Certified Lactation Consultant (IBCLC). Videoconferencing could open new opportunities for leveraging the extensive expertise of the nutrition and lactation workforce in WIC agencies to address rural and remote locations and travel considerations. The purpose of this study will be to evaluate the effectiveness of this telehealth solution.

Description:

Michigan WIC Agency will pilot telehealth opportunities as a means of delivering services to WIC Clients.This video conferencing pilot looks to improve and/or remove barriers such as negative clinic experiences (long wait times or poor customer service), lost time from work (creating job risk and lost wages), inconvenient WIC clinic locations and appointment times, and lack of transportation. Implementing a pilot program in select local agencies to utilize technology would allow clients to connect with a WIC Registered Dietitian (RD) or an International Board-Certified Lactation Consultant (IBCLC). Videoconferencing could open new opportunities for leveraging the extensive expertise of the nutrition and lactation workforce in WIC agencies to address rural and remote locations and travel considerations. Additional urban locations, where clients lack transportation or use of public transportation presents a barrier to traveling to subsequent WIC appointments, will also be included in the pilot. Local agencies in rural and urban areas with similar caseloads will serve as controls to compare outcomes between offering telehealth and conducting IBCLC and RD appointments in person. The purpose of this study is to evaluate the effectiveness of this telehealth solution by having clients complete surveys on their comfortability using telehealth and their satisfaction with the telehealth appointment. Additionally, 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: 1370
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women
• Breastfeeding women
• postpartum women with children in the age range of 0 to 5 years Exclusion Criteria: -

Related Conditions & MeSH terms

• Breast Feeding
• Dietary Intake
• Telehealth

Intervention

Behavioral:
• Telehealth solution
Video conferencing

Locations

Country	Name	City	State
United States	Tufts University	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Tufts University	RTI International, State of Michigan WIC Program, U.S. Department of Agriculture

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 and breastfeeding support 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	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 18 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 18 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 18 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 18 months
Secondary	Barriers encountered in obtaining nutrition education and breastfeeding support	Impact of the telehealth solution compared to usual care on barriers encountered by WIC clients in obtaining nutrition education and breastfeeding support. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.	During the study period, approximately 18 months

External Links

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