Mood and Kids DiEt (MAKE-It): a Pilot Randomized Controlled Trial for a Personalized Dietary Intervention for Adolescents with Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of the Intervention
研究概览
简要总结
This study is being done to examine the feasibility, including recruitment, retention and acceptability of a randomized controlled trial of a personalized dietary intervention 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 testing a personalized nutrition eating plan in a study that uses a randomized controlled trial design for children and youth with depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of MDD
- •Center for Epidemiological Studies Depression Scale for Children (CESD-C) score ≥ 25 at baseline
- •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
- •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)
研究组 & 干预措施
Personalized Nutrition Plan and Support
This group will receive the nutrition intervention
干预措施: Personalized Nutrition Plan and Support (Other)
Control
This group will receive information about Canada's food guide, a recommended healthy diet.
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. Parents and youth will complete this measure.
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. Parents and youth will complete this measure.
次要结局
- Depression Symptoms(Baseline, 9 weeks)
- KIDMED2(Baseline, 9 weeks)
- Automated Self-Administered 24-Hour (ASA24) Dietary Assessment(Baseline, 9 weeks)
- Food Choice Questionnaire(Baseline, 9 weeks)
- Diet Satisfaction(Baseline, 9 weeks)
- International Physical Activity Questionnaire for Adolescents (IPAQ-A)(Baseline, 9 weeks)
- Dutch Eating Behavior Questionnaire(Baseline, 9 weeks)
- Pittsburg Sleep Quality Index (PSQI)(Baseline, 9 weeks)
- Parent Food Modelling(Baseline, 9 weeks)
- Satisfaction with menu planning(Baseline, 9 weeks)
- Satisfaction with nutrition counselling sessions(Baseline, 9 weeks)
- Nutrition Attitude and Knowledge Questionnaire(Baseline, 9 weeks)
- Screen time Questionnaire(Baseline, 9 weeks)
- Family and Nutrition and Physical Activity(Baseline, 9 weeks)
- Screen for Child Anxiety Related Disorders(Baseline, 9 weeks)
- The Revised Child Anxiety and Depression Scale (RCADS)(Baseline, 9 weeks)
研究者
Daphne Korczak
Associate Scientist
The Hospital for Sick Children