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

Study Overview
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Brief Summary
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This study is being done to test the feasibility of a personalized nutrition eating plan in adolescents with depression. Evidence suggests that what we eat every day can influence our 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. We 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.

Detailed Description
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Other: Dietary Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>This group will receive the nutrition intervention | Other: Dietary Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility, Acceptability, and Satisfaction | Acceptability and Feasibility of Intervention Measures (AIM and FIM).[45] The AIM and FIM are self-reported four-item measures scored using a five-point Likert scale ranging from 'completely disagree' (1) to 'completely agree' (5) with higher scores indicating greater acceptability or feasibility. Feasibility, Acceptability and Satisfaction are also assessed by qualitative interviews pre and post study intervention. | Baseline,9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression symptoms | Depression symptoms are assessed using the Centre for Epidemiological Studies Depression Scale for Children (CES-DC), a validated 20-item self-report measure. | Baseline, 5 weeks, 9 weeks | 
| Dietary Assessment | Adolescents' adherence to the personalized nutrition intervention is assessed using the KIDMED questionnaire, a 16-item self- or interviewer-administered measure. | Baseline, 5 weeks, 9 weeks | 
| Nutrition Attitudes and Knowledge questionnaire | 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, as well as 20 multiple-choice and true/false questions related to CFG food groups (Drinks, Whole Grain Foods, Vegetables and Fruit, and Protein Foods). | Baseline, 9 weeks | 
| Parent Food Modelling: | Parental food modelling is evaluated with five items adapted from Cullen's scale, each rated on a four-point Likert scale from Never to Always, which has been used to predict diet outcomes in adolescent samples | Baseline, 9 weeks | 
| Satisfaction with the menu planning and nutrition counselling | Satisfaction with the menu planning and nutrition counselling is rated by parents and adolescents independently following each counselling session using a five-point Likert scale ranging from 'very dissatisfied' (1) to 'very satisfied' (5). | Baseline, 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescents, diet