NCT05934968

Brief Summary

Spinal cord injury (SCI) and multiple sclerosis (MS) are both conditions characterized by chronic inflammation as indicated by elevated levels of circulating pro-inflammatory cytokines. These cytokines can have a wide array of negative impacts such as increasing the risk of depression and the intensity and frequency of neuropathic pain. Recent work in the investigator's laboratory has shown that a 3-month anti-inflammatory diet is not only effective in reducing pro-inflammatory cytokines, but also in reducing depression and neuropathic pain, by approximately 55% and 40%, respectively. However, a one-year follow-up study from the investigator's lab showed such adherence to be very challenging and therefore, strategies are required to address barriers to healthy eating in those with neurological disability. Accordingly, the investigators have developed a modified anti-inflammatory diet (Mad Dog diet) that is more palatable, less expensive and less demanding, as well as a 2-part pre-diet consultation that effectively increased self-efficacy for dietary adherence, and actual adherence one month post-consult. Still, participant feedback suggests that further efforts are needed to help ensure long term adherence to anti-inflammatory diets for those with neurological disability. As such, the investigators have developed the 6-week Mad Dog cooking series. This series consists of a once-weekly cooking class and educational session where a group of individuals with neuromuscular disability can come together to learn about the health benefits of an anti-inflammatory diet, receive instruction on how to cook selected anti-inflammatory recipes, and experiment with various pieces of accessible kitchen equipment that may increase their meal preparation skills. The purpose of this study is to test the 6-week Mad Dog cooking series in individuals with neuromuscular disability to gauge consumer satisfaction and make preliminary measures on self-efficacy for adhering to the Mad Dog anti-inflammatory diet, as well as actual adherence 6 months after the series has been completed. The investigators will also determine if the series has any effect on depressive symptoms.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

June 29, 2023

Last Update Submit

July 6, 2023

Conditions

Outcome Measures

Primary Outcomes (10)

  • Custom-designed task self-efficacy questionnaire

    Confidence in one's abilities to adhere to the anti-inflammatory diet. This is a 4-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 4 and the maximum score is 28, and higher scores indicate greater self-efficacy.

    Baseline (for the intervention group and the control group)

  • Custom-designed task self-efficacy questionnaire

    Confidence in one's abilities to adhere to the anti-inflammatory diet. This is a 4-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 4 and the maximum score is 28, and higher scores indicate greater self-efficacy.

    6-week timepoint (for the intervention group and the control group)

  • Custom-designed task self-efficacy questionnaire

    Confidence in one's abilities to adhere to the anti-inflammatory diet. This is a 4-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 4 and the maximum score is 28, and higher scores indicate greater self-efficacy.

    6-month follow-up timepoint (for the intervention group and the control group)

  • Custom-designed barrier self-efficacy questionnaire

    Confidence in one's ability to overcome the barriers associated with adhering to anti-inflammatory diet. This is a 5-item questionnaire that asks participants how confident they are about overcoming the barriers associated with adhering to the anti-inflammatory diet. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 5 and the maximum score is 35, and higher scores indicate greater self-efficacy.

    Baseline (for the intervention group and the control group)

  • Custom-designed barrier self-efficacy questionnaire

    Confidence in one's ability to overcome the barriers associated with adhering to anti-inflammatory diet. This is a 5-item questionnaire that asks participants how confident they are about overcoming the barriers associated with adhering to the anti-inflammatory diet. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 5 and the maximum score is 35, and higher scores indicate greater self-efficacy.

    6-week timepoint (for the intervention group and the control group)

  • Custom-designed barrier self-efficacy questionnaire

    Confidence in one's ability to overcome the barriers associated with adhering to anti-inflammatory diet. This is a 5-item questionnaire that asks participants how confident they are about overcoming the barriers associated with adhering to the anti-inflammatory diet. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 5 and the maximum score is 35, and higher scores indicate greater self-efficacy.

    6-month follow-up timepoint (for the intervention group and the control group)

  • Adherence to the anti-inflammatory diet

    Participants will complete a 7-day food log. Food logs are then analyzed for the number of servings the participant ate that were approved on the anti-inflammatory diet, the number of servings that were not allowed (cheats) and the total servings eaten over the 7 days. Adherence rates are then determined by calculating \[(servings allowed/total servings) \* 100.

    Baseline (for the intervention group and the control group)

  • Adherence to the anti-inflammatory diet

    Participants will complete a 7-day food log. Food logs are then analyzed for the number of servings the participant ate that were approved on the anti-inflammatory diet, the number of servings that were not allowed (cheats) and the total servings eaten over the 7 days. Adherence rates are then determined by calculating \[(servings allowed/total servings) \* 100.

    6-week timepoint (for the intervention group and the control group)

  • Adherence to the anti-inflammatory diet

    Participants will complete a 7-day food log. Food logs are then analyzed for the number of servings the participant ate that were approved on the anti-inflammatory diet, the number of servings that were not allowed (cheats) and the total servings eaten over the 7 days. Adherence rates are then determined by calculating \[(servings allowed/total servings) \* 100.

    6-month follow-up timepoint (for the intervention group and the control group)

  • Custom-designed consumer satisfaction questionnaire

    Consumer satisfaction with the Mad Dog cooking class series will be measured on a custom designed questionnaire containing 10 items scored on a 7-point scale (1 = strongly disagree, 7 = strongly agree; ex: I feel that I learned new and helpful information in the Mad Dog cooking class series). The minimum score on this questionnaire is 10 and the maximum score is 70, with higher scores indicating greater satisfaction.

    6-week timepoint (for the intervention group only)

Secondary Outcomes (3)

  • Depression as determined by the Centre for Epidemiological Studies depression (CES-D)

    Baseline (for the intervention group and the control group)

  • Depression as determined by the Centre for Epidemiological Studies depression (CES-D)

    6-week timepoint (for the intervention group and the control group)

  • Depression as determined by the Centre for Epidemiological Studies depression (CES-D)

    6-month follow-up timepoint (for the intervention group and the control group)

Study Arms (2)

Mad Dog cooking class intervention group

EXPERIMENTAL

This 6-week series consists of a once-weekly cooking class and educational session where a group of individuals with neuromuscular disability can come together to learn about the health benefits of an anti-inflammatory diet, receive instruction on how to cook selected anti-inflammatory recipes, and experiment with various pieces of accessible kitchen equipment that may increase their meal preparation skills. This series will also allow participants to share a meal together once per week.

Other: Mad Dog cooking class series

Control group

NO INTERVENTION

The control group will be given the Mad Dog recipes but will not take part in the Mad Dog cooking class series.

Interventions

This 6-week series consists of a once-weekly cooking class and educational session where a group of individuals with neuromuscular disability can come together to learn about the health benefits of an anti-inflammatory diet, receive instruction on how to cook selected anti-inflammatory recipes, and experiment with various pieces of accessible kitchen equipment that may increase their meal preparation skills. This series will also allow participants to share a meal together once per week.

Mad Dog cooking class intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be eligible for this study, participants are required to be over 18 years of age, fluent in English and at least one year removed from either spinal cord injury (SCI) or diagnosis of multiple sclerosis (MS). Participants with SCI can have any level or severity of injury while participants with MS can have had any type of MS.

You may not qualify if:

  • Younger than 18
  • Not fluent in English
  • No SCI or diagnosis of MS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brock University

St. Catharines, Ontario, L2S 3A1, Canada

Location

MeSH Terms

Conditions

Spinal Cord InjuriesMultiple SclerosisInflammationDepressionTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorHealth Behavior

Study Officials

  • David S Ditor, PhD

    Brock University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David S Ditor, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 29, 2023

First Posted

July 7, 2023

Study Start

September 1, 2023

Primary Completion

June 1, 2024

Study Completion

August 1, 2024

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Available upon reasonable request to the Principal Investigator

Locations