RecruitingNot ApplicableNCT06716034

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

Sponsor

The Hospital for Sick Children

Enrollment

20 participants

Start Date

Feb 18, 2025

Study Type

INTERVENTIONAL

Conditions

Depression - Major Depressive Disorder Adolescent

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

Min Age: 11 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This pilot study (MAKE-It) is testing whether dietary changes can help improve mood and reduce symptoms of depression in children and teens. It is aimed at young people with major depressive disorder (MDD) and will test whether a healthier diet, supported through an online program, leads to better mental health outcomes. **You may be eligible if...** - You (or your child) have been diagnosed with major depressive disorder (MDD) - Depression score on the CESD-C scale is 25 or higher - You have access to the internet and a smartphone or computer - A parent or guardian is willing to participate alongside the child **You may NOT be eligible if...** - You currently have a very high-quality diet - You have an eating disorder - You are currently in another dietary study or program - You are actively trying to gain or lose weight - You have a chronic medical condition - You have an unstable psychiatric condition (e.g., mania or active thoughts of suicide) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPersonalized 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.