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Completed

NCT Number: NCT06175052

A Personalized Nutrition Intervention for Adolescent Depression

This study is being done to test the feasibility of a personalized nutrition eating plan 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 a personalized nutrition eating plan for children and youth with depression. Previous research has shown that it helps improve depressive symptoms in adults, but it is not clear if the same is true for children and youth.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

The proposed 8-week, mixed-methods, single-arm study aims to examine the feasibility of an adjunctive personalized dietary intervention for adolescents with major depressive disorder. The secondary aims are to determine potential barriers and facilitators of implementation and to improve adherence and uptake.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of MDD as determined by semi-structured diagnostic interview
  • 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, as determined by semi-structured diagnostic interview
  • 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)

Treatment and study plan

Dietary Intervention

Other

Four nutrition counselling sessions conducted over eight weeks, in conjunction with food items to assist in meal preparation and with weekly educational information messages sent via email.

Primary outcomes

  1. Feasibility of the Intervention

    Time frame: Baseline, 9 weeks

    Feasibility of Intervention Measure (FIM). The FIM is a self-reported four-item measure scored using a five-point Likert scale ranging from 'completely disagree' (1) to 'completely agree' (5) with higher scores indicating greater acceptability or feasibility. Higher scores indicate greater feasibility with a maximum score of 20.

  2. Acceptability of the Intervention

    Time frame: Baseline, 9 weeks

    Acceptability of Intervention Measure (AIM). The AIM is a self-reported four-item measure scored using a five-point Likert scale ranging from 'completely disagree' (1) to 'completely agree' (5) with higher scores indicating greater acceptability or feasibility. Higher scores indicate greater acceptability with a maximum score of 20.

  3. Feasibility, Acceptability, and Satisfaction of the Intervention

    Time frame: Baseline, 9 weeks

    Feasibility, Acceptability, and Satisfaction are also assessed using semi-structured qualitative interviews pre- and post-study intervention.

Secondary outcomes

  1. Depression symptoms

    Time frame: Baseline, 5 weeks, 9 weeks

    Depression symptoms are assessed using the Centre for Epidemiological Studies Depression Scale for Children (CES-DC), a validated 20-item self-report measure. Participants rated their symptoms on a four-point Likert scale, with higher scores indicating more severe depression symptoms, and a maximum total score of 60.

  2. Dietary Assessment

    Time frame: Baseline, 5 weeks, 9 weeks

    Adolescents' adherence to the personalized nutrition intervention is assessed using the Mediterranean Diet Quality Index for children and adolescents (KIDMED) questionnaire, a 16-item self- or interviewer-administered measure. Scores range from 0-12. A total score of ≤ 3 indicates poor adherence; a score of 4-7 indicates moderate adherence; a score of ≥8 indicates high adherence.

  3. Nutrition Attitudes and Knowledge questionnaire

    Time frame: Baseline, 9 weeks

    Nutrition attitudes and knowledge are assessed using a Nutrition Attitudes and Knowledge questionnaire, designed to evaluate children's understanding of the 2019 Canada Food Guide (CFG). The questionnaire consists of four five-point Likert scale questions to measure positive attitudes about nutrition with higher scores indicating a stronger belief that healthy eating is important and a maximum score of 20. Additionally, 20 multiple-choice and true/false questions relate to CFG food groups (Drinks, Whole Grain Foods, Vegetables and Fruit, and Protein Foods). Higher scores indicate greater nutrition knowledge and the maximum possible score is also 20.

  4. Parent Food Modelling:

    Time frame: Baseline, 9 weeks

    Parental food modelling is evaluated with 10 items adapted from Cullen's scale, each rated on a four-point Likert scale from 'Never' (0) to 'Always' (3) which has been used to predict diet outcomes in adolescent samples. Higher scores signify greater healthful parental food modeling, with a maximum score of 30.

  5. Satisfaction with menu planning

    Time frame: Baseline, 9 weeks

    Satisfaction with menu planning is evaluated through a single item, independently assessed by parents and adolescents using a five-point Likert scale that ranges from 'very dissatisfied' (1) to 'very satisfied' (5).

  6. Satisfaction with nutrition counselling sessions

    Time frame: Baseline, 9 weeks

    Satisfaction with nutrition counseling sessions is evaluated through a single item, independently assessed by parents and adolescents using a five-point Likert scale that ranges from 'very dissatisfied' (1) to 'very satisfied' (5).

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

A Personalized Nutrition Intervention for Adolescent Depression: A Mixed-Methods Pilot

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 18, 2023
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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