South Carolina WIC Telehealth Solution

Sponsor
Tufts University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05887869
Collaborator
U.S. Department of Agriculture (Other), South Carolina Department of Health and Environmental Control (DHEC) (Other), RTI International (Other)
5,300
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15.9
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Study Details

Study Description

Brief Summary

With funding through USDA and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, the South Carolina WIC department will be implementing a telehealth solution for nutrition and breastfeeding support. The purpose of this study is to evaluate this telehealth solution. The research/evaluation involves completing online surveys. The evaluation will focus on participant satisfaction, usage of the telehealth solution, and use of information collected on the WIC participant through the WIC management information system (MIS). It is hypothesized that the telehealth solution will increase WIC participant's satisfaction with nutrition and breastfeeding support while also reducing the burden of attending in-person care.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Telehealth solution
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
5300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Study participants will be clients at local WIC agency sites where either the telehealth solution is offered or where only usual care is available (control).Study participants will be clients at local WIC agency sites where either the telehealth solution is offered or where only usual care is available (control).
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
South Carolina Telehealth Solution
Actual Study Start Date :
Apr 4, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telehealth solution

Telehealth solution offered

Behavioral: Telehealth solution
Telehealth solution offered for nutrition education and breastfeeding support.

No Intervention: Usual care

Control

Outcome Measures

Primary Outcome Measures

  1. Satisfaction with the telehealth solution [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.

Secondary Outcome Measures

  1. Breastfeeding duration [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

  2. Attendance at scheduled appointments [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.

  3. Dietary intake [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.

  4. Attitudes to breastfeeding and nutrition education [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.

  5. Barriers encountered in obtaining nutrition education and breastfeeding support [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Pregnant women

  • Breastfeeding women

  • Postpartum women with children in the age range of 0 to 5 years

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tufts University Boston Massachusetts United States 02111

Sponsors and Collaborators

  • Tufts University
  • U.S. Department of Agriculture
  • South Carolina Department of Health and Environmental Control (DHEC)
  • RTI International

Investigators

  • Principal Investigator: Erin Hennessy, PhD, Tufts University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Erin Hennessy, Assistant Professor, Division of Nutrition Interventions, Communication and Behavior Change Director ad interim, ChildObesity180 Friedman School of Nutrition Science and Policy, Tufts University
ClinicalTrials.gov Identifier:
NCT05887869
Other Study ID Numbers:
  • IRB.22-012
First Posted:
Jun 5, 2023
Last Update Posted:
Jun 5, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Erin Hennessy, Assistant Professor, Division of Nutrition Interventions, Communication and Behavior Change Director ad interim, ChildObesity180 Friedman School of Nutrition Science and Policy, Tufts University

Study Results

No Results Posted as of Jun 5, 2023