- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05967234
THIS-WIC Vermont Breastfeeding Education Application Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telehealth solution
Telehealth solution offered for breastfeeding education.
|
Telehealth solution offered for breastfeeding education.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction with the telehealth solution
Time Frame: During the study period, approximately 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of use of the telehealth solution
Time Frame: During the study period, approximately 12 months
|
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
|
|
Intent to breastfeed
Time Frame: During the study period, approximately 12 months
|
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
|
|
Breastfeeding duration
Time Frame: During the study period, approximately 12 months
|
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
|
|
Attitudes to breastfeeding
Time Frame: During the study period, approximately 12 months
|
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
|
|
Barriers encountered in use of the telehealth solution and breastfeeding
Time Frame: During the study period, approximately 12 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erin Hennessy, PhD, Tufts University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB # 308
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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