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Mood And Kids diEt (MAKE-It) Pilot Trial

NCT06716034 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-18
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06716034 on ClinicalTrials.gov