Mood and Kids DiEt (MAKE-It) Pilot Trial (MAKE-IT pRCT)

The Hospital for Sick Children

Status: Enrolling

Conditions: Adolescent; Depression - Major Depressive Disorder

Treatments: Other: Personalized Nutrition Plan and Support

Study type: Interventional

Funder types: Other

Identifiers

NCT06716034

MAKE-IT pRCT

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Personalized Nutrition Plan and Support

Experimental group

Description:

This group will receive the nutrition intervention

Treatment:

Other: Personalized Nutrition Plan and Support

Control

No Intervention group

Description:

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