DepressionNCT06175052
A Personalized Nutrition Intervention for Adolescent Depression
A study testing Dietary Intervention in people with Depression, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Personalized Nutrition Intervention for Adolescent Depression: A Mixed-Methods Pilot
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Dietary Intervention
- Keywords
- adolescents, diet
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
Four nutrition counselling sessions conducted over eight weeks, in conjunction with food items to assist in meal preparation and with weekly educational information messages sent via email.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Nutrition | Experimental | This group will receive the nutrition intervention Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Intervention
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.
Measured: Baseline, 9 weeks
Acceptability of the Intervention
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.
Measured: Baseline, 9 weeks
Feasibility, Acceptability, and Satisfaction of the Intervention
Feasibility, Acceptability, and Satisfaction are also assessed using semi-structured qualitative interviews pre- and post-study intervention.
Measured: Baseline, 9 weeks
Secondary outcomes (6)
Depression symptoms
Depression symptoms are assessed using the Centre for Epidemiological Studies Depression Scale for Children (CES-DC), a validated 20-item self-report measure. Participants rated their symptoms on a four-point Likert scale, with higher scores indicating more severe depression symptoms, and a maximum total score of 60.
Measured: Baseline, 5 weeks, 9 weeks
Dietary Assessment
Adolescents' adherence to the personalized nutrition intervention is assessed using the Mediterranean Diet Quality Index for children and adolescents (KIDMED) questionnaire, a 16-item self- or interviewer-administered measure. Scores range from 0-12. A total score of ≤ 3 indicates poor adherence; a score of 4-7 indicates moderate adherence; a score of ≥8 indicates high adherence.
Measured: Baseline, 5 weeks, 9 weeks
Nutrition Attitudes and Knowledge questionnaire
Nutrition attitudes and knowledge are assessed using a Nutrition Attitudes and Knowledge questionnaire, designed to evaluate children's understanding of the 2019 Canada Food Guide (CFG). The questionnaire consists of four five-point Likert scale questions to measure positive attitudes about nutrition with higher scores indicating a stronger belief that healthy eating is important and a maximum score of 20. Additionally, 20 multiple-choice and true/false questions relate to CFG food groups (Drinks, Whole Grain Foods, Vegetables and Fruit, and Protein Foods). Higher scores indicate greater nutrition knowledge and the maximum possible score is also 20.
Measured: Baseline, 9 weeks
Parent Food Modelling:
Parental food modelling is evaluated with 10 items adapted from Cullen's scale, each rated on a four-point Likert scale from 'Never' (0) to 'Always' (3) which has been used to predict diet outcomes in adolescent samples. Higher scores signify greater healthful parental food modeling, with a maximum score of 30.
Measured: Baseline, 9 weeks
Satisfaction with menu planning
Satisfaction with menu planning is evaluated through a single item, independently assessed by parents and adolescents using a five-point Likert scale that ranges from 'very dissatisfied' (1) to 'very satisfied' (5).
Measured: Baseline, 9 weeks
Satisfaction with nutrition counselling sessions
Satisfaction with nutrition counseling sessions is evaluated through a single item, independently assessed by parents and adolescents using a five-point Likert scale that ranges from 'very dissatisfied' (1) to 'very satisfied' (5).
Measured: Baseline, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 May 2022
- Primary completion15 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daphne Korczak, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175052
- Sponsor's protocol ID
- TeenDiet_Dep
- Status last verified
- Jan 2024
- First submitted
- 8 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Nutrition Intervention for Adolescent Depression: A Mixed-Methods Pilot
- ClinicalTrials.gov ID
- NCT06175052
- Acronym / sponsor ID
- TeenDiet_Dep
- Conditions
- Depression
- Keywords
- adolescents, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized Nutrition | Experimental | Other: Dietary InterventionThis group will receive the nutrition intervention |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary InterventionFour nutrition counselling sessions conducted over eight weeks, in conjunction with food items to assist in meal preparation and with weekly educational information messages sent via email. | Other | Personalized Nutrition |
Primary outcome
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.
6 secondary outcomes
Depression symptoms
Time frame: Baseline, 5 weeks, 9 weeks
Dietary Assessment
Time frame: Baseline, 5 weeks, 9 weeks
Nutrition Attitudes and Knowledge questionnaire
Time frame: Baseline, 9 weeks
Parent Food Modelling:
Time frame: Baseline, 9 weeks
Satisfaction with menu planning
Time frame: Baseline, 9 weeks
Satisfaction with nutrition counselling sessions
Time frame: Baseline, 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Depression, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention (time frame: Baseline, 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.