Examining the Efficacy of a Digital Media Intervention to Increase Recruitment Rates (WHEAT-Boost)

December 2, 2025 updated by: Dr. Balpreet Singh, IWK Health Centre

Examining the Efficacy of a Parent-targeted Co-designed Digital Media Intervention to Increase Recruitment Rates Across a Multi-site Randomized Clinical Trial in Canadian NICU's

WHEAT-Boost is a Study Within A Trial (SWAT) that aims to improve how families are recruited into neonatal research studies by testing a new way of sharing information. The study is embedded within the larger WHEAT International Trial, a randomized clinical trial being conducted in Neonatal Intensive Care Units (NICUs) across Canada. The WHEAT International Trial investigates the best way to manage feeding around the time of blood transfusions in very premature infants (born before 30 weeks of pregnancy).

Recruiting families for research in the NICU is challenging. Parents are often stressed, overwhelmed, and unfamiliar with how clinical trials work, which can make it hard for them to process complex medical information and decide whether to take part. Traditional consent methods, such as paper forms, may not be enough to ensure families feel informed and comfortable with participation.

To address this, WHEAT-Boost will test whether adding a short, co-designed digital video helps improve recruitment rates. The video is 3.5 to 4 minutes long, available in English and French (with subtitles in other commonly spoken languages), and explains the importance of NICU research and details of the WHEAT International Trial in a simple and visual way. The video was co-developed with parents who have experience in the NICU to ensure the information is relevant and easy to understand.

NICU sites participating in the WHEAT Trial will be randomly assigned, in a stepped-wedge design schedule, to either continue using their usual recruitment methods, or to add the digital video to their recruitment approach. Parents in both groups will be asked to complete a short, voluntary questionnaire about their experience with the consent process and their understanding of the trial.

The main goal of WHEAT-Boost is to see if the video increases the number of families who agree to take part in the WHEAT Trial (known as the "opt-in rate"). The study will also look at whether the video reduces the number of families who later withdraw from the trial, and whether it improves parents' understanding of the study and their satisfaction with how information was shared.

If successful, the video could be used in other NICUs or future studies to help make research more accessible and inclusive for families. This approach could lead to stronger participation in neonatal trials, better-informed decisions by parents, and faster progress in improving care for premature babies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

WHEAT-Boost is a stepped-wedge cluster randomized SWAT embedded within the ongoing WHEAT International Trial (NCT05213806), which evaluates feeding practices around blood transfusion in preterm infants. The SWAT aims to examine whether the addition of a co-designed digital media intervention improves recruitment outcomes, parental comprehension, and satisfaction with the research consent process in the NICU setting.

Fifteen Canadian NICUs participating in the WHEAT International Trial will be randomized in a stepped-wedge design to transition from the control condition (usual recruitment approach) to the intervention condition (usual approach plus video). Each site will act as its own control, with transitions occurring at 29-day intervals. All sites will begin in the control arm, using standard informed or opt-out consent materials, and then sequentially implement the video intervention according to the randomized schedule.

The intervention consists of a 3.5- to 4-minute digital video co-developed with a parent-partner advisory group. The video uses accessible language, storytelling, and visual elements to highlight the role and value of neonatal research and to clarify key details of the WHEAT Trial. It is delivered via a QR code linked to a secure website, enabling families to view the content on personal or institutional devices. The co-design approach ensures the material is tailored to the needs and concerns of NICU families, many of whom may experience emotional distress and information overload during their infant's hospitalization.

This SWAT will evaluate several outcomes. The primary outcome is the WHEAT Trial opt-in rate, defined as the proportion of eligible families who consent to enroll their infant in the trial. Secondary outcomes include the post-randomization withdrawal rate, parental comprehension of trial-specific information, and overall experience with the consent process. These will be measured using a brief questionnaire co-designed with the parent group and administered to all approached families, regardless of group assignment.

Analysis of the primary and secondary outcomes will follow intention-to-treat principles and will use generalized linear mixed models appropriate for the stepped-wedge design. Models will include random intercepts for sites and fixed effects for time and intervention status. For qualitative data from open-ended survey responses, an inductive thematic analysis approach will be applied.

This SWAT addresses a critical need for evidence-based strategies to enhance trial recruitment in high-stress clinical environments like the NICU. By supplementing conventional consent procedures with engaging, accessible media, the study seeks to normalize research participation and support informed decision-making by parents of vulnerable infants. If effective, this low-cost, scalable intervention could be readily adapted to other trials and clinical settings, advancing broader efforts to improve inclusivity and transparency in neonatal research.

Study Type

Interventional

Enrollment (Estimated)

787

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Recruiting
        • Royal Alexandra Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Recruiting
        • BC Women's Hospital and Health Centre
    • NFLD
      • Saint Johns, NFLD, Canada
        • Recruiting
        • Janeway Children's Health and Rehabilitation Centre
    • New Brunswick
      • Fredericton, New Brunswick, Canada
        • Recruiting
        • Dr. Everett Chalmers
      • Moncton, New Brunswick, Canada
        • Recruiting
        • Moncton Hospital
      • Saint John, New Brunswick, Canada
        • Recruiting
        • Saint John Regional Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Recruiting
        • IWK Health
    • Ontario
      • Kingston, Ontario, Canada
        • Recruiting
        • Kingston Health Sciences Centre
      • London, Ontario, Canada
        • Recruiting
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada
        • Recruiting
        • The Ottawa Hospital/CHEO
      • Toronto, Ontario, Canada
        • Recruiting
        • Mount Sinai
      • Windsor, Ontario, Canada
        • Recruiting
        • Windsor Regional Hospital
    • Quebec
      • Laval, Quebec, Canada
        • Recruiting
        • Centre Hospitalier de l'Universite Laval
      • Montreal, Quebec, Canada
        • Recruiting
        • Montreal Children's Hospital
      • Sherbrooke, Quebec, Canada
        • Recruiting
        • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (applied to infants/participants in WHEAT Trial):

Infant meets eligibility criteria for the WHEAT International Trial

Infant is <30 weeks gestational age at birth

Infant is admitted to one of the participating Canadian NICU sites

Parent(s)/primary caregiver(s) are approached for consent to participate in the WHEAT Trial during a time period when the SWAT is active at their site

Exclusion Criteria:

Infant or family ineligible for participation in the WHEAT International Trial

Parent(s)/primary caregiver(s) not approached for WHEAT Trial participation (e.g., missed recruitment window, language barriers not addressed by materials, medical instability of infant or family)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control (No-Video) Arm
Participants receive the standard informed consent or opt-out consent documentation for the WHEAT International Trial without any additional digital media support. Research staff approach parents/primary caregivers using the usual verbal and paper-based consent process. Families then complete a brief questionnaire about their understanding and experience with the consent process.
Experimental: Intervention (Video) Arm

Participants receive the usual informed consent or opt-out consent documentation plus access to a co-designed 3.5-4-minute digital media video that explains the importance of neonatal research and key trial details in an accessible format. The video is intended to supplement and clarify the consent process to improve understanding and recruitment.

Research staff provide parents/primary caregivers with a QR code linking to the video hosted on the WHEAT International Trial website. Families are encouraged to watch the video on their personal devices or hospital devices if needed. This is provided alongside the usual consent documentation during the NICU stay. Following this, families complete the same brief questionnaire about their experience and comprehension.
Behavioral: Intervention (Video) Arm
A 3.5-4-minute co-designed digital media video created to supplement the standard consent process for the WHEAT International Trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opt-in Rate for the WHEAT International Trial
Time Frame: Baseline (When the family is approached for the Study Participation - Within first two weeks of life))
The proportion of families approached for participation in the WHEAT International Trial who provide consent (or do not opt out, depending on the site's consent model) for their infant to be enrolled.
Baseline (When the family is approached for the Study Participation - Within first two weeks of life))

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trial Withdrawal Rate (Post-Randomization)
Time Frame: Birth to 40 weeks Post Menstrual Age (From enrollment until study completion)
The proportion of enrolled participants who withdraw from the WHEAT International Trial after randomization.
Birth to 40 weeks Post Menstrual Age (From enrollment until study completion)
Parental Comprehension of Trial-Specific Details
Time Frame: Baseline (Once family makes the consent decision - Within first two weeks of life)
Degree to which parents understand key elements of the WHEAT International Trial, assessed via a brief questionnaire co-designed with a parent-partner group.
Baseline (Once family makes the consent decision - Within first two weeks of life)
Parental Experience with the Consent Process
Time Frame: Baseline (Once family makes the consent decision - Within first two weeks of life)
Parents' perceptions of the clarity, helpfulness, and adequacy of the information provided during the consent process, collected via a brief, co-designed questionnaire.
Baseline (Once family makes the consent decision - Within first two weeks of life)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Investigators

  • Principal Investigator: Balpreet Singh, IWK Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2025

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1027137 (SWAT)
  • CTR-184893/ CT1-184892 (Other Grant/Funding Number: ACT/CIHR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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