- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05887869
South Carolina WIC Telehealth Solution
South Carolina Telehealth Solution
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 South Carolina 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 South Carolina's telehealth solution to inform how the telehealth platform supports WIC services compared to usual in-person care. 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 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.
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:
- Pregnant women
- Breastfeeding women
- Postpartum women with children in the age range of 0 to 5 years
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telehealth solution
Telehealth solution offered
|
Telehealth solution offered for nutrition education and breastfeeding support.
|
|
No Intervention: Usual care
Control
|
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 18 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance at scheduled appointments
Time Frame: During the study period, approximately 18 months
|
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
|
|
Dietary intake
Time Frame: During the study period, approximately 18 months
|
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
|
|
Attitudes to breastfeeding and nutrition education
Time Frame: During the study period, approximately 18 months
|
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
|
|
Barriers encountered in obtaining nutrition education and breastfeeding support
Time Frame: During the study period, approximately 18 months
|
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
|
|
Breastfeeding duration
Time Frame: During the study period, approximately 18 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
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
Other Study ID Numbers
- IRB.22-012
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
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