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临床试验/NCT06175052
NCT06175052已完成不适用

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

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Feasibility of the Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Feasibility of the Intervention

时间窗: 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

时间窗: 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

时间窗: Baseline, 9 weeks

Feasibility, Acceptability, and Satisfaction are also assessed using semi-structured qualitative interviews pre- and post-study intervention.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daphne Korczak

Associate Scientist

The Hospital for Sick Children

研究点 (2)

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