A short co-designed video to help parents decide about neonatal research participation
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
This project will test whether adding a short, co-designed digital video helps parents of very premature infants in Canadian NICUs understand and feel comfortable joining the WHEAT feeding study.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 787 (estimated) |
| Ages | N/A to 30 Weeks |
| Sex | All |
| Sponsor | IWK Health Centre Academic / other |
| Locations | 15 sites (Edmonton, Alberta and 14 other locations) |
| Trial ID | NCT07284329 on ClinicalTrials.gov |
What this trial studies
WHEAT-Boost is a stepped-wedge cluster randomized embedded study within the WHEAT International Trial that sequentially introduces a 3.5–4 minute co-designed digital video across participating Canadian NICUs. Fifteen sites begin with usual recruitment materials and transition to the intervention at randomized 29-day intervals, with each site serving as its own control. The video, accessible via QR code on a secure website and created with parent partners, uses plain language and visuals to explain neonatal research and key details of the WHEAT Trial. Primary outcomes include recruitment rates, parental comprehension, and satisfaction with the consent process in the NICU setting.
Who should consider this trial
Good fit: Parents or primary caregivers of infants born before 30 weeks gestation who are admitted to one of the participating Canadian NICUs and are approached for the WHEAT International Trial while the SWAT is active are ideal candidates.
Not a fit: Families who are not approached for WHEAT, whose infants are ineligible for the parent trial, who face unaddressed language barriers, or who are too medically or emotionally unstable at the time of approach may not benefit from the intervention.
Why it matters
Potential benefit: If successful, this approach could increase enrollment and help parents make more informed, comfortable decisions about enrolling their very preterm infants in neonatal research.
How similar studies have performed: Previous multimedia and co-designed consent tools in other clinical settings have shown mixed but generally promising improvements in participant understanding and satisfaction, though evidence is limited specifically in NICU-embedded SWATs.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Edmonton, Alberta and 14 other locations
- Royal Alexandra Hospital — Edmonton, Alberta, Canada (Recruiting)
- BC Women's Hospital and Health Centre — Vancouver, British Columbia, Canada (Recruiting)
- Dr. Everett Chalmers — Fredericton, New Brunswick, Canada (Recruiting)
- Moncton Hospital — Moncton, New Brunswick, Canada (Recruiting)
- Saint John Regional Hospital — Saint John, New Brunswick, Canada (Recruiting)
- Janeway Children's Health and Rehabilitation Centre — Saint Johns, Nfld, Canada (Recruiting)
- IWK Health — Halifax, Nova Scotia, Canada (Recruiting)
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- The Ottawa Hospital/CHEO — Ottawa, Ontario, Canada (Recruiting)
- Mount Sinai — Toronto, Ontario, Canada (Recruiting)
- Windsor Regional Hospital — Windsor, Ontario, Canada (Recruiting)
- Centre hospitalier de l'Université Laval — Laval, Quebec, Canada (Recruiting)
- Montreal Children's Hospital — Montreal, Quebec, Canada (Recruiting)
- Centre hospitalier universitaire de Sherbrooke — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Balpreet Singh — IWK Health
- Study coordinator: Cari-Lee Carnell
- Email: cari-lee.carnell@iwk.nshealth.ca
- Phone: 902-219-2216
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.