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Clinical Trials/NCT06175052
NCT06175052
Completed
Not Applicable

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

The Hospital for Sick Children1 site in 1 country10 target enrollmentMay 1, 2022
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
The Hospital for Sick Children
Enrollment
10
Locations
1
Primary Endpoint
Feasibility of the Intervention
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
July 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daphne Korczak

Associate Scientist

The Hospital for Sick Children

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

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

  • Parent Food Modelling:(Baseline, 9 weeks)
  • Depression symptoms(Baseline, 5 weeks, 9 weeks)
  • Dietary Assessment(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)

Study Sites (1)

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