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Recruiting NCT06716034

Mood And Kids diEt (MAKE-It) Pilot Trial

No phase Interventional Depression - Major Depressive Disorder Adolescent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Personalized Nutrition Plan and Support.
Who it may be relevant to
Registry conditions: Depression - Major Depressive Disorder, Adolescent. Basic parameters: 11 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Mood And Kids diEt (MAKE-It): A Pilot Randomized Controlled Trial for a Personalized Dietary Intervention for Adolescents With Depression

Overview

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.

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 behaviou

Primary outcome measures

  • Feasibility of the Intervention [Time frame: Baseline, 9 weeks]
  • Acceptability of the Intervention [Time frame: Baseline, 9 weeks]
Secondary outcome measures (12)
  • Depression Symptoms [Time frame: Baseline, 9 weeks]
  • Depression Symptoms [Time frame: Baseline, 9 weeks]
  • KIDMED2 [Time frame: Baseline, 9 weeks]
  • Automated Self-Administered 24-Hour (ASA24) Dietary Assessment [Time frame: Baseline, 9 weeks]
  • Food Choice Questionnaire [Time frame: Baseline, 9 weeks]
  • Diet Satisfaction [Time frame: Baseline, 9 weeks]
  • International Physical Activity Questionnaire for Adolescents (IPAQ-A) [Time frame: Baseline, 9 weeks]
  • Dutch Eating Behavior Questionnaire [Time frame: Baseline, 9 weeks]
  • Pittsburg Sleep Quality Index (PSQI) [Time frame: Baseline, 9 weeks]
  • Parent Food Modelling [Time frame: Baseline, 9 weeks]
  • Satisfaction with menu planning [Time frame: Baseline, 9 weeks]
  • Satisfaction with nutrition counselling sessions [Time frame: Baseline, 9 weeks]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Canada · 1 center
  • The Hospital for Sick Children — Toronto

Identifiers

NCT: NCT06716034 · MAKE-IT pRCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗