Mood And Kids diEt (MAKE-It) Pilot Trial

NCT ID: NCT06716034

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-18
• Study Completion Date: 2026-06-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Personalized Nutrition Plan and Support

This group will receive the nutrition intervention

Group Type: EXPERIMENTAL

Personalized Nutrition Plan and Support

Intervention Type: OTHER

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.

Control

This group will receive information about Canada's food guide, a recommended healthy diet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Daphne Korczak

Associate Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Daphne J Korczak, MD

Role: CONTACT

daphne.korczak@sickkids.ca

416-813-8923 ext. 208923

Facility Contacts

Daphne J Korczak, MD, MSc, FRCPC

Role: primary

daphne.korczak@sickkids.ca

416-813-6936

Susan Campisi, PhD

Role: backup

susan.campisi@sickkids.ca

416-813-7654 ext. 301774

Other Identifiers

MAKE-IT pRCT

Identifier Type: -

Identifier Source: org_study_id