CClinicalTrials.gg
CompletedNCT05854186Updated May 31, 2024

Georgia: Technology and WIC - A Comprehensive Approach to Public Health

An interventional study of Telehealth solution: video conferencing in Telehealth, Nutrition Education and Breast Feeding, sponsored by Tufts University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-31.

Sponsored by Tufts University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Dec 2021, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
2,566
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

With funding through USDA and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, the Georgia 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.

Read the 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 GA 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 GA's video-conferencing 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.

02

Conditions studied

  • Telehealth
  • Nutrition Education
  • Breast Feeding
  • Dietary Intake
  • WIC

Keywords

  • Telehealth
  • WIC
  • nutrition education
  • breast feeding
  • dietary intake
03

In context

Lead sponsor

Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,566 participants (actual)

Study arms

  • Experimental
    Telehealth solution

    Telehealth solution offered.

    Behavioral: Telehealth solution: video conferencing

  • No intervention
    Control

    Usual care.

Interventions

  • BehavioralTelehealth solution: video conferencing

    Telehealth solution: video conferencing

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During the study period, approximately 18 months

Secondary outcomes

  1. 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

    Time frame: During the study period, approximately 18 months

  2. 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.

    Time frame: During the study period, approximately 18 months

  3. 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.

    Time frame: During the study period, approximately 18 months

  4. 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.

    Time frame: During the study period, approximately 18 months

  5. 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.

    Time frame: During the study period, approximately 18 months

07

Study locations

1 site
  • Tufts University
    Boston, Massachusetts 02111, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05854186
Lead sponsor
Tufts University
Collaborators
United States Department of Agriculture (USDA), Georgia Department of Public Health, Division of Health Promotion, RTI International
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) — Principal investigator
First posted
May 11, 2023
Start date
Dec 29, 2021
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023
Last update
May 31, 2024

Study contacts

Erin Hennessy, PhD
principal investigator · Tufts University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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