Clinical trial NCT06716034: Mood And Kids diEt (MAKE-It) Pilot Trial
Official title: Mood And Kids diEt (MAKE-It): A Pilot Randomized Controlled Trial for a Personalized Dietary Intervention for Adolescents With Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression - Major Depressive Disorder
Adolescent
Keywords: adolescent
diet
depression
randomized controlled trial
pilot
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: Baseline, 9 weeks
measure: Acceptability of the Intervention
timeFrame: Baseline, 9 weeks
Secondary outcomes:
measure: Depression Symptoms
timeFrame: Baseline, 9 weeks
measure: Depression Symptoms
timeFrame: Baseline, 9 weeks
measure: KIDMED2
timeFrame: Baseline, 9 weeks
measure: Automated Self-Administered 24-Hour (ASA24) Dietary Assessment
timeFrame: Baseline, 9 weeks
measure: Food Choice Questionnaire
timeFrame: Baseline, 9 weeks
measure: Diet Satisfaction
timeFrame: Baseline, 9 weeks
measure: International Physical Activity Questionnaire for Adolescents (IPAQ-A)
timeFrame: Baseline, 9 weeks
measure: Dutch Eating Behavior Questionnaire
timeFrame: Baseline, 9 weeks
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: Baseline, 9 weeks
measure: Parent Food Modelling
timeFrame: Baseline, 9 weeks
measure: Satisfaction with menu planning
timeFrame: Baseline, 9 weeks
measure: Satisfaction with nutrition counselling sessions
timeFrame: Baseline, 9 weeks
measure: Nutrition Attitude and Knowledge Questionnaire
timeFrame: Baseline, 9 weeks
measure: Screen time Questionnaire
timeFrame: Baseline, 9 weeks
measure: Family and Nutrition and Physical Activity
timeFrame: Baseline, 9 weeks
measure: Screen for Child Anxiety Related Disorders
timeFrame: Baseline, 9 weeks
measure: The Revised Child Anxiety and Depression Scale (RCADS)
timeFrame: Baseline, 9 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: