NCT05746741

Brief Summary

With funding through the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC), Michigan's (MI) WIC department will pilot telehealth opportunities as a means of delivering services to WIC Clients. This video conferencing pilot looks to improve and/or remove barriers. Implementing a pilot program in select local agencies to utilize technology would allow clients to connect with a WIC Registered Dietitian (RD) or an International Board-Certified Lactation Consultant (IBCLC). Videoconferencing could open new opportunities for leveraging the extensive expertise of the nutrition and lactation workforce in WIC agencies to address rural and remote locations and travel considerations. The purpose of this study will be to evaluate the effectiveness of this telehealth solution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
386

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 10, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
9 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

2 years

First QC Date

February 16, 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

Control

NO INTERVENTION

Usual care

Interventions

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

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

February 16, 2023

First Posted

February 28, 2023

Study Start

December 10, 2021

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

May 31, 2024

Record last verified: 2024-05

Locations