TelehealthNCT05746741
Telehealth Intervention Strategies for WIC (THIS-WIC)- Michigan
A study testing Telehealth solution in people with Telehealth and Nutrition Education, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Telehealth, Nutrition Education, Breast Feeding
- What is being tested?
- Telehealth solution
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2021to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women
- Breastfeeding women
- postpartum women with children in the age range of 0 to 5 years
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Telehealth, Nutrition Education, Breast Feeding, Dietary Intake, WIC
- Being tested
- Telehealth solution
- Keywords
- Telehealth, WIC, nutrition education, breast feeding, dietary intake
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth solutionBehavioural
Video conferencing
| Study group | Role | What they receive |
|---|---|---|
| Telehealth solution | Experimental | Telehealth solution offered Receives: Behavioral: Telehealth solution |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the study period, approximately 18 months
Secondary outcomes (5)
Breastfeeding duration
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.
Measured: During the study period, approximately 18 months
Attendance at scheduled appointments
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.
Measured: During the study period, approximately 18 months
Dietary intake
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.
Measured: During the study period, approximately 18 months
Attitudes to breastfeeding and nutrition education
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.
Measured: During the study period, approximately 18 months
Barriers encountered in obtaining nutrition education and breastfeeding support
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.
Measured: During the study period, approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start10 Dec 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelehealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), State of Michigan WIC Program, RTI International
- Responsible party
- Principal investigator, Erin Hennessy, Tufts University
- Investigators
- Erin Hennessy, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746741
- Sponsor's protocol ID
- 202112-01-EA / STUDY00002536
- Status last verified
- May 2024
- First submitted
- 16 Feb 2023
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Intervention Strategies for WIC (THIS-WIC)- Michigan
- ClinicalTrials.gov ID
- NCT05746741
- Acronym / sponsor ID
- 202112-01-EA / STUDY00002536
- Conditions
- Telehealth, Nutrition Education, Breast Feeding, Dietary Intake, WIC
- Keywords
- Telehealth, WIC, nutrition education, breast feeding, dietary intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), State of Michigan WIC Program, RTI International
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Telehealth solution | Experimental | Behavioral: Telehealth solutionTelehealth solution offered |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women
- Breastfeeding women
- postpartum women with children in the age range of 0 to 5 years
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth solutionVideo conferencing | Behavioural | Telehealth solution |
Primary outcome
Satisfaction with the telehealth solution
Time frame: 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.
5 secondary outcomes
Breastfeeding duration
Time frame: During the study period, approximately 18 months
Attendance at scheduled appointments
Time frame: During the study period, approximately 18 months
Dietary intake
Time frame: During the study period, approximately 18 months
Attitudes to breastfeeding and nutrition education
Time frame: During the study period, approximately 18 months
Barriers encountered in obtaining nutrition education and breastfeeding support
Time frame: During the study period, approximately 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Tufts Telehealth Intervention Strategies for WIC (THIS-WIC) websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Hennessy, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth solution in people with Telehealth and Nutrition Education, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the telehealth solution (time frame: During the study period, approximately 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.