Recruiting

MAKE-ItMood And Kids diEt (MAKE-It) Pilot Trial

Sponsor:

The Hospital for Sick Children

Code:

NCT06716034

Conditions

Depression - Major Depressive Disorder

Adolescent

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

Interventions

Personalized Nutrition Plan and Support

Study Details

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 ID

NCT06716034

Start date

Feb 18, 2025

Status verified date

Oct, 2024

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Personalized Nutrition Plan and Support

This group will receive the nutrition intervention

no intervention: Control

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

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.

Primary outcome measure

Feasibility of the Intervention [ Time Frame: Baseline, 9 weeks ]
Acceptability of the Intervention [ Time Frame: Baseline, 9 weeks ]

Central Contacts and Locations

Central contacts

Daphne J Korczak, MD

416-813-8923 daphne.korczak@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G1X8

Contacts

Daphne J Korczak, MD, MSc, FRCPC

416-813-6936 daphne.korczak@sickkids.ca

Susan Campisi, PhD

416-813-7654 susan.campisi@sickkids.ca

Principal Investigator:

Daphne J Korczak, MD, MSc, FRCPC

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Mar 25, 2025

Last verified

Oct, 2024

Keywords

adolescent
diet
depression
randomized controlled trial
pilot

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2025-03-25.