🏛️ Verified NIH Record • Updated 2025-03-24

Mood And Kids diEt (MAKE-It) Pilot Trial (NCT06716034)

Mood And Kids diEt (MAKE-It): A Pilot Randomized Controlled Trial for a Personalized Dietary Intervention for Adolescents With Depression

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: The Hospital for Sick Children

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (7 items).

Location: The Hospital for Sick Children — Toronto, Ontario

Age range: 11 Years to 17 Years

🧪 Interventions in This Study

  • Personalized Nutrition Plan and Support (OTHER)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • The Hospital for Sick Children — Toronto, Ontario

📞 Contact the Study Coordinator

Phone: (416) 813-8923

Email: daphne.korczak@sickkids.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗