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Clinical Trials/NCT06175052
NCT06175052CompletedNot Applicable

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

The Hospital for Sick Children1 site in 1 country10 target enrollmentStarted: May 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Feasibility, Acceptability, and Satisfaction of the Intervention

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
11 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Personalized Nutrition

Experimental

This group will receive the nutrition intervention

Intervention: Dietary Intervention (Other)

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Dietary Assessment(Baseline, 5 weeks, 9 weeks)
  • Parent Food Modelling:(Baseline, 9 weeks)
  • Depression symptoms(Baseline, 5 weeks, 9 weeks)
  • Nutrition Attitudes and Knowledge questionnaire(Baseline, 9 weeks)
  • Satisfaction with menu planning(Baseline, 9 weeks)
  • Satisfaction with nutrition counselling sessions(Baseline, 9 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daphne Korczak

Associate Scientist

The Hospital for Sick Children

Study Sites (1)

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