AzTrials
AzTrials

Spinal Cord InjuriesNCT05934968

Mad Dog Cooking Class Series: Effects on Dietary Self-efficacy, Eating Behaviors and Health Outcomes

A study testing Mad Dog cooking class series in people with Spinal Cord Injuries and Multiple Sclerosis, run by Brock University 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mad Dog cooking class series
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteCanada
Study dates
Sep 2023to Aug 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

David S Ditor, PhD contact

905-688-5550 ext. 5338

dditor@brocku.ca

Canada1 site
  • Brock University

    St. Catharines, Ontario, L2S 3A1

    David S Ditor, PhD, 905-688-5550 ext. 5338, dditor@brocku.ca

Other trials in Canada

About this study

Official title: The Effects of the 6-week Mad Dog Anti-inflammatory Cooking Class Series on Dietary Self-efficacy, Eating Behaviors and Health Outcomes in People With Neurological Disability

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.

Read more

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.

Read the detailed description

As mentioned above, the Mad Dog cooking series consists of 6 once-weekly cooking classes and educational sessions 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. These classes will take place in the kitchen in the Brock Research and Innovation Centre (130 Lockhart Drive) which is a completely accessible building. The classes will be led by a Brock University graduate student and take approximately 90 minutes each, and each class will have a different theme (See below). This series will also allow participants to share a meal together once per week which the investigators expect (based on past feedback) to foster a sense of community and belonging, improve mood and increase the likelihood of long term adherence to the anti-inflammatory diet.

Schedule:

Week 1: Introduction to Anti-Inflammatory Eating (Veggies and Pita with Mad Dog Hummus, Mad Dog Thai Curry, Mad Dog Nut Mix) Week 2: Focus on Breakfast (Chocolate Protein Smoothie, Poached Eggs Potato Hash and Wilted Kale, Overnight Oats) Week 3: Healthy Flavors of the Globe (Baked Plantain and Sweet Potato Chips, Lentil Tacos with rice and beans, Sugarless Sticky Toffee Pudding) Week 4: Tribute to Canada (Split Pea Soup, Chicken Tourtière with roasted veggies, Nanaimo Bars) Week 5: Anti-Inflammatory Powerhouses (Green Juice, Chicken Breast with Kale and Wild Rice Salad, Turmeric Coconut Bites) Week 6: Protein Positive (White Bean Dip with veggies and crackers, Vegetarian Chili, Sweet Potato Protein Pudding)

Being tested
Mad Dog cooking class series
Medical subject headings
Spinal Cord Injuries, Multiple Sclerosis, Inflammation, Depression, Treatment Adherence and Compliance

What participants receive

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

  • Mad Dog cooking class seriesOther

    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.

Study groups in NCT05934968
Study groupRoleWhat they receive
Mad Dog cooking class intervention groupExperimentalThis 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.
Receives: Other: Mad Dog cooking class series
Control groupNo interventionThe control group will be given the Mad Dog recipes but will not take part in the Mad Dog cooking class series.

What is being measured

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

  1. 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.

    Measured: Baseline (for the intervention group and the control group)

  2. 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.

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

  3. 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.

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

  4. 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.

    Measured: Baseline (for the intervention group and the control group)

  5. 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.

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

  6. 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.

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

  7. 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.

    Measured: Baseline (for the intervention group and the control group)

  8. 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.

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

  9. 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.

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

  10. 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.

    Measured: 6-week timepoint (for the intervention group only)

Secondary outcomes (3)
  1. Depression as determined by the Centre for Epidemiological Studies depression (CES-D)

    Depression as determined by the Centre for Epidemiological Studies depression (CES-D) This is a 20-item questionnaire that asks participants to rate their depressive symptoms over the last 7 days, and each item is scored from 0-3. The minimum score for the questionnaire 0 and the maximum score is 60, with higher scores indicating worse depressive symptomology. Any score above 15 is indicative of clinical depression, but should not be taken as a diagnosis by itself.

    Measured: Baseline (for the intervention group and the control group)

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

    Depression as determined by the Centre for Epidemiological Studies depression (CES-D) This is a 20-item questionnaire that asks participants to rate their depressive symptoms over the last 7 days, and each item is scored from 0-3. The minimum score for the questionnaire 0 and the maximum score is 60, with higher scores indicating worse depressive symptomology. Any score above 15 is indicative of clinical depression, but should not be taken as a diagnosis by itself.

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

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

    Depression as determined by the Centre for Epidemiological Studies depression (CES-D) This is a 20-item questionnaire that asks participants to rate their depressive symptoms over the last 7 days, and each item is scored from 0-3. The minimum score for the questionnaire 0 and the maximum score is 60, with higher scores indicating worse depressive symptomology. Any score above 15 is indicative of clinical depression, but should not be taken as a diagnosis by itself.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study startSep 2023 (estimated)
  3. Primary completionJun 2024 (estimated)
  4. Study completionAug 2024 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05934968
Sponsor's protocol ID
22-337 - Ditor
Status last verified
Jul 2023
First submitted
29 Jun 2023
Last updated
7 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Available upon reasonable request to the Principal Investigator

Questions about this trial

What is this clinical trial studying?

A study testing Mad Dog cooking class series in people with Spinal Cord Injuries and Multiple Sclerosis, run by Brock University 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 1 inclusion and 3 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 7 Jul 2023. 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 David S Ditor, PhD (905-688-5550 ext. 5338, dditor@brocku.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Custom-designed task self-efficacy questionnaire (time frame: Baseline (for the intervention group and the control group)). The study lists 10 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 7 Jul 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in