A Personalized Nutrition Intervention for Adolescent Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06175052
• Other study ID #: TeenDiet_Dep
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: January 2024
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 31, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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