THIS-WIC Vermont Breastfeeding Education Application Feasibility Study

Sponsor
Tufts University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05967234
Collaborator
U.S. Department of Agriculture (Other), Vermont WIC (Other), RTI International (Other)
500
1
1
12.2
41.1

Study Details

Study Description

Brief Summary

With funding through USDA and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, the Vermont WIC department will be conducting a feasibility study of a mobile telehealth solution for breastfeeding education. The purpose of this study is to evaluate this telehealth solution. The research/evaluation involves completing online surveys and interviews. The evaluation will focus on participant satisfaction, usage of the telehealth solution, and use of information collected on WIC participant through the WIC management information system (MIS) and the telehealth platform. It is hypothesized that the telehealth solution will increase WIC participant's satisfaction with breastfeeding education.

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 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 Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Study participants will be clients at local WIC agency sites where the telehealth solution is offeredStudy participants will be clients at local WIC agency sites where the telehealth solution is offered
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
THIS-WIC Vermont Breastfeeding Education Application Feasibility Study
Actual Study Start Date :
Dec 26, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telehealth solution

Telehealth solution offered for breastfeeding education.

Behavioral: Telehealth solution
Telehealth solution offered for breastfeeding education.

Outcome Measures

Primary Outcome Measures

  1. Satisfaction with the telehealth solution [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.

Secondary Outcome Measures

  1. Frequency of use of the telehealth solution [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.

  2. Intent to breastfeed [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.

  3. Breastfeeding duration [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.

  4. Attitudes to breastfeeding [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.

  5. Barriers encountered in use of the telehealth solution and breastfeeding [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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:

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
  • Vermont WIC
  • 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:
NCT05967234
Other Study ID Numbers:
  • IRB # 308
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 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 Aug 1, 2023