Telehealth Intervention Strategies for WIC (THIS-WIC)- Michigan

Sponsor
Tufts University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05746741
Collaborator
U.S. Department of Agriculture (Other), State of Michigan WIC Program (Other), RTI International (Other)
1,370
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2
19.7
69.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Telehealth solution
N/A

Detailed Description

Michigan WIC Agency will pilot telehealth opportunities as a means of delivering services to WIC Clients.This video conferencing pilot looks to improve and/or remove barriers such as negative clinic experiences (long wait times or poor customer service), lost time from work (creating job risk and lost wages), inconvenient WIC clinic locations and appointment times, and lack of transportation. 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. Additional urban locations, where clients lack transportation or use of public transportation presents a barrier to traveling to subsequent WIC appointments, will also be included in the pilot. Local agencies in rural and urban areas with similar caseloads will serve as controls to compare outcomes between offering telehealth and conducting IBCLC and RD appointments in person.

The purpose of this study is to evaluate the effectiveness of this telehealth solution by having clients complete surveys on their comfortability using telehealth and their satisfaction with the telehealth appointment. Additionally, 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 :
1370 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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).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).
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Telehealth Intervention Strategies for WIC (THIS-WIC)- Michigan
Actual Study Start Date :
Dec 10, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telehealth solution

Telehealth solution offered

Behavioral: Telehealth solution
Video conferencing

No Intervention: Control

Usual care

Outcome Measures

Primary Outcome Measures

  1. Satisfaction with the telehealth solution [During the study period, approximately 18 months]

    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.

Secondary Outcome Measures

  1. Breastfeeding duration [During the study period, approximately 18 months]

    Duration of breastfeeding in clients offered the telehealth solution compared to usual care. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.

  2. Attendance at scheduled appointments [During the study period, approximately 18 months]

    WIC clients attendance at appointments when offered the telehealth solution compared to usual care. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.

  3. Dietary intake [During the study period, approximately 18 months]

    Impact of the telehealth solution compared to usual care on dietary intake. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.

  4. Attitudes to breastfeeding and nutrition education [During the study period, approximately 18 months]

    Impact of the telehealth solution compared to usual care on WIC clients' attitudes to breastfeeding and nutrition education. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.

  5. Barriers encountered in obtaining nutrition education and breastfeeding support [During the study period, approximately 18 months]

    Impact of the telehealth solution compared to usual care on barriers encountered by WIC clients in obtaining nutrition education and breastfeeding support. 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:
  • Pregnant women

  • Breastfeeding women

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

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
  • State of Michigan WIC Program
  • 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:
NCT05746741
Other Study ID Numbers:
  • 202112-01-EA / STUDY00002536
First Posted:
Feb 28, 2023
Last Update Posted:
Feb 28, 2023
Last Verified:
Feb 1, 2023
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 Feb 28, 2023