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Depression - Major Depressive DisorderMAKE-IT pRCTNCT06716034

Mood And Kids diEt (MAKE-It) Pilot Trial

A study testing Personalized Nutrition Plan and Support in people with Depression - Major Depressive Disorder and Adolescent, run by The Hospital for Sick Children at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 17 years
What is being tested?
Personalized Nutrition Plan and Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
18 Feb 2025to 1 Jun 2026
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
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting
  • The Hospital for Sick Children

    Toronto, Ontario, M5G1X8

    Daphne J Korczak, MD, MSc, FRCPC, 416-813-6936, daphne.korczak@sickkids.ca

    Susan Campisi, PhD, 416-813-7654 ext. 301774, susan.campisi@sickkids.ca

    Recruiting

Other trials in Canada

About this study

Official title: Mood And Kids diEt (MAKE-It): A Pilot Randomized Controlled Trial for a Personalized Dietary Intervention for Adolescents With Depression

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.

Being tested
Personalized Nutrition Plan and Support
Keywords
adolescent, diet, depression, randomized controlled trial, pilot
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized Nutrition Plan and SupportOther

    The intervention is a virtually-delivered, personalized nutrition plan and support to improve dietary intake of healthy food (fruit, vegetables and whole grains), based on the principles of a Mediterranean-style diet. Components of the intervention include nutrition counselling, menu planning and the provision of groceries, delivered biweekly, face-to-face, by a registered dietitian over 8 weeks, using a virtual platform. The nutrition counselling structure is grounded in evidence-based behaviour change theory for dietary interventions. Youth and parents will co-develop a personalized menu plan. In addition to biweekly nutrition counselling, participants will receive a food pantry basket, and weekly grocery deliveries to support the menu plan.

Study groups in NCT06716034
Study groupRoleWhat they receive
Personalized Nutrition Plan and SupportExperimentalThis group will receive the nutrition intervention
Receives: Other: Personalized Nutrition Plan and Support
ControlNo interventionThis group will receive information about Canada's food guide, a recommended healthy diet.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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. Parents and youth will complete this measure.

    Measured: Baseline, 9 weeks

  2. 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. Parents and youth will complete this measure.

    Measured: Baseline, 9 weeks

Secondary outcomes (17)
  1. Depression Symptoms

    Self-reported depression severity will be measured using the Centre for Epidemiological Studies Depression - Children (CES-DC) instrument, a 20 item youth-report measure that assesses symptoms of depression with demonstrated good reliability and validity. Participants will be asked to rate their depression symptoms on a 4-point Likert scale. Higher scores represent greater symptom severity with a maximum potential total score of 60. Youth will complete this measure.

    Measured: Baseline, 9 weeks

  2. Depression Symptoms

    Clinician-rated depression symptoms will be assessed using the Children's Depression Rating Scale Revised (CDRS-R). The CDRS-R, a semi-structured clinical interview which takes 15-20 min to administer, is a widely used interviewer-administered rating scales for measuring depression symptoms in intervention studies of adolescent depression. The measure assesses depression symptoms, rated on 5- to 7-point Likert rating scales. Depression symptom domains are aligned with the diagnostic criteria for depression and include sleep disturbance, excessive fatigue, suicidal ideation, and social withdrawal. Participants are asked about information on 14 items. Youth will complete this measure.

    Measured: Baseline, 9 weeks

  3. KIDMED2

    The 'KIDMED2' questionnaire will evaluate dietary intake in relation to the Mediterranean Diet in children and adolescents. KIDMED2 is a 16-item questionnaire that can be self-administered or conducted by an interview with responses being yes/no. Items related to lower adherence are assigned a value of -1 (4 items) and those related to higher adherence +1 (12 items). Scores range from 0-12. A total score of ≤ 3 is considered poor adherence; a score of 4-7 is considered medium adherence and ≥8 is high adherence. Youth will complete this measure.

    Measured: Baseline, 9 weeks

  4. Automated Self-Administered 24-Hour (ASA24) Dietary Assessment

    The National Cancer Institute's Automated Self-Administered 24-Hour (ASA24) Dietary Assessment is a validated tool that employs the Automated Multiple-Pass Method and is freely available in the public domain. Usual or habitual dietary intake requires two ASA24 dietary intake measures one during the week and another on a weekend day. Reported energy intake (rEI) and nutrient intakes will be generated automatically by the ASA24 software using the ASA24-Canada-2018 version, released in April 2019 and food composition data from the Canadian Nutrient File as well as data from the Food and Nutrient Database for Dietary Studies. Youth will complete this measure.

    Measured: Baseline, 9 weeks

  5. Food Choice Questionnaire

    The Food Choice Questionnaire is a 36-item self-administered questionnaire that evaluates factors which influence dietary choices. Factors which might influence food choices are divided into 9 subscales, which are labelled health, mood, convenience, sensory appeal, natural content, price, weight control, familiarity and ethical concern. Items are scored on a 4-point Likert scale ranging from 1 (not important at all) to 4 (very important). Higher subscale scores reflect a greater emphasis on that particular factor when selecting foods. Youth will complete this measure.

    Measured: Baseline, 9 weeks

  6. Diet Satisfaction

    Diet satisfaction will be assessed using the Diet Satisfaction Score (DSS), a comprehensive tool consisting of 10 items focused on measuring a singular dimension. The DSS demonstrates strong reliability through a robust intraclass correlation coefficient of 0.64. Moreover, the minimal mean difference (95% confidence interval, CI) between repeated test scores stands at 0.03 (-0.02, 0.09), affirming its stability. Participants rate their level of agreement on a 5-point Likert-type scale across the 10 statements, spanning from 'strongly agree' to 'strongly disagree.' Higher scores on this scale directly correlate with greater satisfaction with the diet. Calculated as the mean of all items, the total score ranges from 1 to 5, with 5 signifying optimal satisfaction. Higher scores indicate a stronger sense of satisfaction with the diet. Youth will complete this measure.

    Measured: Baseline, 9 weeks

  7. International Physical Activity Questionnaire for Adolescents (IPAQ-A)

    The International Physical Activity Questionnaire for Adolescents (IPAQ-A) is a self-reported questionnaire that measures physical activity (PA) in the last 7 days. Participants will estimate the number of occasions per week for activities such as sitting, walking, leisure cycling, running and/or aerobics. The total number of days and minutes of PA will be reported as metabolic equivalent of task (MET) per hour per week, with greater METs indicating greater physical activity. Using the IPAQ scoring protocol, PA will be reported as a continuous variable - the metabolic equivalent of task (MET) minutes per week and as a three-level categorical variable (using IPAQ-A cut-points): low level of activity; moderate level of activity; or high level of activity. Youth will complete this measure.

    Measured: Baseline, 9 weeks

  8. Dutch Eating Behavior Questionnaire

    Eating behaviour will be assessed with The Dutch Eating Behavior Questionnaire (DEBQ), a 33-item self-report questionnaire to comprises three scales assessing restrained eating (DEBQ-R), emotional eating (DEBQ-E), and external eating (DEBQ-X) behaviour. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behaviour. A score of 15 or higher indicates a risk for depression in children and adolescents. The scale has demonstrated good to excellent internal consistency (α = 0.84 - 0.92) and factorial validity. Youth will complete this measure.

    Measured: Baseline, 9 weeks

  9. Pittsburg Sleep Quality Index (PSQI)

    The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire designed to assess sleep quality and disturbances within a one-month timeframe. It comprises 19 individual items contributing to the calculation of seven "component" scores each scored 0 (no difficulty) to 3 (severe difficulty): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of these seven component scores yields one global score ranging from 0 to 21 with the higher total score indicating worse sleep quality. In distinguishing between good and poor sleepers, a global PSQI score > 5 yields a sensitivity of 89.6% and a specificity of 86.5%. Youth will complete this measure.

    Measured: Baseline, 9 weeks

  10. 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. Youth will complete this measure.

    Measured: Baseline, 9 weeks

  11. 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). Parents and youth will complete this measure.

    Measured: Baseline, 9 weeks

  12. 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). Parents and youth will complete this measure.

    Measured: Baseline, 9 weeks

  13. Nutrition Attitude and Knowledge Questionnaire

    The Nutrition Attitudes and Knowledge (NAK) questionnaire is a brief questionnaire developed by a team of educators and dietitians to assess knowledge of the 2019 Canada Food Guide. We have adapted the NAK for this study. The adapted NAK questionnaire contains 22 items, with one section evaluating nutrition attitudes and four sections assessing nutrition knowledge associated with the different food groups. The nutrition attitudes section contains four 5-point Likert scale questions (e.g., "Eating healthy now can help me be healthy in the future"), with higher scores indicating more positive attitudes about nutrition. Thirteen multiple choice and five true/false questions were developed to reflect knowledge of the CFG food groups: Drinks, Whole Grain Foods, Vegetables and Fruit, and Protein foods (both animal and plant-based). Parents and youth will complete this measure.

    Measured: Baseline, 9 weeks

  14. Screen time Questionnaire

    The Questionnaire for Screen Time of Adolescents (QueST) is a self-reported questionnaire to assess screen time on a typical day. Participants are asked how much time they spend on screens across five constructs: studying, working/internship-related activities, watching videos, playing games, and using social media/chat applications on weekdays and again on weekends. Items are summed to obtain total weekday and weekend screen time. The QueST test-retest intra-class correlation coefficients range from 0.76 for social media use on weekdays to 0.24 for watching videos on weekends. Youth will complete this measure.

    Measured: Baseline, 9 weeks

  15. Family and Nutrition and Physical Activity

    The Family and Nutrition and Physical Activity (FNPA) screening tool is a behaviorally-based assessment designed to allow parents to evaluate the family food environment and practices. FNPA has been extensively used in child and adolescent obesity research but also in studies examining diabetes prevention, family eating behaviour and cardiovascular risk factors.

    The FNPA is a 20-item screening tool with 10-constructs. Parents are asked to rate their child's behaviour on a 4-point Likert scale ranging from almost never to very often. 6 items are reverse scored for the following questions and construct 3-Family Eating Practices, 4- Family Eating Practices, 5-Food Choices, 7-Beverage Choices, 10-Restriction/Reward, 13-Healthy Environment. Higher scores reflect more healthy home environments since no cut points or thresholds have been established for determining healthy vs unhealthy home environments. Parents will complete this measure.

    Measured: Baseline, 9 weeks

  16. Screen for Child Anxiety Related Disorders

    Screen for Child Anxiety Related Disorders (SCARED) and the Revised Children's Anxiety and Depression Scale (RCAD) contains 41 items and measures rated on 3-point Likert-type scale anxiety using four domains: panic/somatic, separation anxiety, generalized anxiety, and school phobia with three possible responses ranging from ' not true or hardly ever true' to very often true or often true'. Parents will complete this measure.

    Measured: Baseline, 9 weeks

  17. The Revised Child Anxiety and Depression Scale (RCADS)

    The Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P) is a 47-item self-report questionnaire with subscales including separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive-compulsive disorder (OCD), and major depressive disorder (MDD). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Items are rated on a 4-point Likert scale from 0 ("never") to 3 ("always"). Parents will complete this measure.

    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.

  1. First posted4 Dec 2024
  2. Study start18 Feb 2025
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06716034
Sponsor's protocol ID
MAKE-IT pRCT
Acronym
MAKE-IT pRCT
Status last verified
Oct 2024
First submitted
29 Nov 2024
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Nutrition Plan and Support in people with Depression - Major Depressive Disorder and Adolescent, 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 4 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: status not confirmed, as of the sponsor's last update on 25 Mar 2025. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daphne J Korczak, MD (416-813-8923 ext. 208923, daphne.korczak@sickkids.ca), or a site near the patient. 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 2 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 25 Mar 2025.

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