NCT06716034 Mood And Kids diEt (MAKE-It) Pilot Trial
| NCT ID | NCT06716034 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Depression - Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-02-18 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-02-18 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is being done to examine the feasibility, including recruitment, retention and acceptability of a randomized controlled trial of a personalized dietary intervention in adolescents with depression. Evidence suggests that dietary quality may affect an individual's mood. A healthy diet includes vegetables, fruit, nuts, seeds, and olive oil, as well as minimally processed whole grains, legumes, and moderate amounts of lean meat, fish, and dairy. The investigators will examine the feasibility of testing a personalized nutrition eating plan in a study that uses a randomized controlled trial design for children and youth with depression.
Eligibility Criteria
Inclusion Criteria: * diagnosis of MDD * Center for Epidemiological Studies Depression Scale for Children (CESD-C) score ≥ 25 at baseline * access to the internet and a computer or smart phone * presence of a parent who is willing to participate Exclusion Criteria: * adherent to a high-quality diet at baseline * presence of an eating disorder * currently participating in other dietary programs or studies * actively attempting to increase or decrease body weight; * presence of a chronic medical condition; * unstable psychiatric condition (e.g., mania, active suicidal ideation)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06716034 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 17 Years, studying Depression - Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06716034 currently recruiting?
Yes, NCT06716034 is actively recruiting participants. Contact the research team at daphne.korczak@sickkids.ca for enrollment information.
Where is the NCT06716034 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06716034 clinical trial?
NCT06716034 is sponsored by The Hospital for Sick Children. The trial plans to enroll 20 participants.
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