Personalized dietary intervention for adolescents with depression
Mood And Kids diEt (MAKE-It): A Pilot Randomized Controlled Trial for a Personalized Dietary Intervention for Adolescents With Depression
This study is trying out a personalized diet plan for teenagers with depression to see if eating healthier can help improve their mood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 11 Years to 17 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06716034 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to assess the feasibility of a randomized controlled trial that tests a personalized dietary intervention for adolescents diagnosed with Major Depressive Disorder (MDD). The study will focus on recruitment, retention, and acceptability of the intervention, which emphasizes a healthy diet rich in fruits, vegetables, nuts, and whole grains. Participants will receive a tailored nutrition plan and support to help improve their dietary habits and potentially their mood. The trial will involve adolescents who meet specific criteria related to their depression severity and dietary habits.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents diagnosed with Major Depressive Disorder who have a CESD-C score of 25 or higher.
Not a fit: Patients who are already adhering to a high-quality diet or have an eating disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel approach to managing depression in adolescents through dietary changes.
How similar studies have performed: While dietary interventions for mental health are being explored, this specific approach is relatively novel and has not been extensively tested in this population.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Toronto, Ontario
- The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Daphne J Korczak, MD
- Email: daphne.korczak@sickkids.ca
- Phone: 416-813-8923
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.