NCT05854186

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,566

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

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 29, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
7 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

1.9 years

First QC Date

May 2, 2023

Last Update Submit

May 29, 2024

Conditions

Keywords

TelehealthWICnutrition educationbreast feedingdietary intake

Outcome Measures

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.

    During the study period, approximately 18 months

Secondary Outcomes (5)

  • Breastfeeding duration

    During the study period, approximately 18 months

  • Attendance at scheduled appointments

    During the study period, approximately 18 months

  • Dietary intake

    During the study period, approximately 18 months

  • Attitudes to breastfeeding and nutrition education

    During the study period, approximately 18 months

  • Barriers encountered in obtaining nutrition education and breastfeeding support

    During the study period, approximately 18 months

Study Arms (2)

Telehealth solution

EXPERIMENTAL

Telehealth solution offered.

Behavioral: Telehealth solution: video conferencing

Control

NO INTERVENTION

Usual care.

Interventions

Telehealth solution: video conferencing

Telehealth solution

Eligibility Criteria

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

You may qualify if:

  • Pregnant women
  • Breastfeeding women
  • postpartum women with children in the age range of 0 to 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

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
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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).
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

May 2, 2023

First Posted

May 11, 2023

Study Start

December 29, 2021

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