THIS-WIC Telehealth Solutions: Evaluation With North Carolina WIC Clients

Sponsor
Tufts University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05854199
Collaborator
U.S. Department of Agriculture (Other), North Carolina Department of Health and Human Services (Other), RTI International (Other)
38,600
1
2
11.5
3356.8

Study Details

Study Description

Brief Summary

With funding through the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, North Carolina (NC) WIC department will be implementing new, nutrition education telehealth in NC's WIC program. The purpose of this study is to evaluate the impact of the telehealth platform. The evaluation will focus on NC WIC clients as the study population. The North Carolina WIC department would be implementing this education platform, regardless of the evaluation research. The North Carolina WIC department is responsible for implementing this new intervention, while the Tufts University research team is responsible for the evaluation of this platform through surveys and analysis of administrative data.

An online survey will be used to gauge WIC clients' satisfaction with the telehealth solution and the impact of the telehealth solution compared to usual care on breastfeed duration, dietary intake, attendance at scheduled appointments, attitudes to breastfeeding and nutrition education, and barriers encountered. Survey data will be combined with previously collected data on clients and their families from the NC Management Information Systems (MIS), and aggregate level data from the telehealth solution about utilization.

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 NC 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 NC's telehealth solution to inform how the telehealth solution supports WIC services compared to usual in-person care. The NC telehealth platform includes a mobile-optimized website, meaning that it functions as an app without requiring the amount of memory and data that apps use. Evaluation findings will inform stakeholders about the platform's benefits and how viable it is to sustain and adapt more widely.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38600 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:
THIS-WIC Telehealth Solutions: Evaluation With North Carolina WIC Clients
Actual Study Start Date :
Aug 16, 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 nutrition education platform

No Intervention: Usual care

Control

Outcome Measures

Primary Outcome Measures

  1. Satisfaction with the telehealth solution [During the study period, approximately 12 months]

    WIC clients satisfaction with nutrition education 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 12 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 12 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 12 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 12 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 [During the study period, approximately 12 months]

    Impact of the telehealth solution compared to usual care on barriers encountered by WIC clients in obtaining nutrition education. 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

  • postpartum women

  • parent/guardian of a participating infant or child in the WIC program

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).

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
  • North Carolina Department of Health and Human Services
  • 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:
NCT05854199
Other Study ID Numbers:
  • STUDY00002935
First Posted:
May 11, 2023
Last Update Posted:
May 11, 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 May 11, 2023