A Personalized Nutrition Intervention for Adolescent Depression

NCT06175052 | Completed

• 1 other identifier: TeenDiet_Dep
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression

Keywords

adolescents; diet

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 9 weeks

Secondary Outcomes (6)

• Depression symptoms

  Baseline, 5 weeks, 9 weeks

• Dietary Assessment

  Baseline, 5 weeks, 9 weeks

• Nutrition Attitudes and Knowledge questionnaire

  Baseline, 9 weeks

• Parent Food Modelling:

  Baseline, 9 weeks

• Satisfaction with menu planning

  Baseline, 9 weeks

Study Arms (1)

Personalized Nutrition

EXPERIMENTAL

This group will receive the nutrition intervention

Other: Dietary Intervention

Interventions

Dietary Intervention OTHER

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.

Personalized Nutrition

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Depression

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: May 1, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 31, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)