NCT05967234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 26, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

June 6, 2023

Last Update Submit

May 29, 2024

Conditions

Keywords

TelehealthWICBreast feeding

Outcome Measures

Primary Outcomes (1)

  • Satisfaction with the telehealth solution

    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.

    During the study period, approximately 12 months

Secondary Outcomes (5)

  • Frequency of use of the telehealth solution

    During the study period, approximately 12 months

  • Intent to breastfeed

    During the study period, approximately 12 months

  • Breastfeeding duration

    During the study period, approximately 12 months

  • Attitudes to breastfeeding

    During the study period, approximately 12 months

  • Barriers encountered in use of the telehealth solution and breastfeeding

    During the study period, approximately 12 months

Study Arms (1)

Telehealth solution

EXPERIMENTAL

Telehealth solution offered for breastfeeding education.

Behavioral: Telehealth solution

Interventions

Telehealth solution offered for breastfeeding education.

Telehealth solution

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Erin Hennessy, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Study participants will be clients at local WIC agency sites where the telehealth solution is offered
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Division of Nutrition Interventions, Communication and Behavior Change Director ad interim, ChildObesity180 Friedman School of Nutrition Science and Policy

Study Record Dates

First Submitted

June 6, 2023

First Posted

August 1, 2023

Study Start

December 26, 2022

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations