NCT06716034

Mood And Kids diEt (MAKE-It) Pilot Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression - Major Depressive Disorder
• Adolescent

Interventions

Type	Name	Description
OTHER	Personalized Nutrition Plan and Support	The intervention is a virtually-delivered, personalized nutrition plan and support to improve dietary intake of healthy food (fruit, vegetables and whole grains), based on the principles of a Mediterranean-style diet. Components of the intervention include nutrition counselling, menu planning and the provision of groceries, delivered biweekly, face-to-face, by a registered dietitian over 8 weeks, using a virtual platform. The nutrition counselling structure is grounded in evidence-based behaviour change theory for dietary interventions. Youth and parents will co-develop a personalized menu plan. In addition to biweekly nutrition counselling, participants will receive a food pantry basket, and weekly grocery deliveries to support the menu plan.

Timeline

• Start date: 2025-02-18
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-12-04
• Last updated: 2025-03-25

Locations

1 site across 1 country: Canada