A Personalized Nutrition Intervention for Adolescent Depression (TeenDietMDD)

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Other: Dietary Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized Nutrition; This group will receive the nutrition intervention	Other: Dietary Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Intervention	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.	Baseline, 9 weeks
Acceptability of the Intervention	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.	Baseline, 9 weeks
Feasibility, Acceptability, and Satisfaction of the Intervention	Feasibility, Acceptability, and Satisfaction are also assessed using semi-structured 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. 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.	Baseline, 5 weeks, 9 weeks
Dietary Assessment	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.	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 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.	Baseline, 9 weeks
Parent Food Modelling:	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.	Baseline, 9 weeks
Satisfaction with menu planning	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).	Baseline, 9 weeks
Satisfaction with nutrition counselling sessions	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).	Baseline, 9 weeks

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: adolescents; diet
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: TeenDiet_Dep

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No