NCT05726448

Brief Summary

With funding through the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, Wisconsin's (WI) WIC department will be implementing a new, customized, mobile-friendly nutrition education platform called ONE (Online Nutrition Education) in WI's WIC program. The purpose of this study is to evaluate the impact of the ONE platform. The evaluation will focus on WIC clients as the study population. The Wisconsin WIC department would be implementing this education platform, regardless of the evaluation research. The Wisconsin 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 ONE, 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 WI Management Information Systems (MIS), and aggregate level data from the ONE telehealth solution about ONE utilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
10 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

January 5, 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 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

    During the study period, approximately 18 months

Study Arms (2)

Telehealth solution

EXPERIMENTAL

Telehealth solution offered

Behavioral: Telehealth solution

Usual care

NO INTERVENTION

Control

Interventions

Mobile-friendly nutrition education platform

Telehealth solution

Eligibility Criteria

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

You may qualify if:

  • 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).

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
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

January 5, 2023

First Posted

February 14, 2023

Study Start

January 12, 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