- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05934968
Mad Dog Cooking Class Series: Effects on Dietary Self-efficacy, Eating Behaviors and Health Outcomes
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David S Ditor, PhD
- Phone Number: 5338 905-688-5550
- Email: dditor@brocku.ca
Study Locations
-
-
Ontario
-
St. Catharines, Ontario, Canada, L2S 3A1
- Brock University
-
Contact:
- David S Ditor, PhD
- Phone Number: 5338 905-688-5550
- Email: dditor@brocku.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Younger than 18
- Not fluent in English
- No SCI or diagnosis of MS
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mad Dog cooking class intervention group
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.
|
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.
|
|
No Intervention: Control group
The control group will be given the Mad Dog recipes but will not take part in the Mad Dog cooking class series.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Custom-designed task self-efficacy questionnaire
Time Frame: Baseline (for the intervention group and the control group)
|
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
Time Frame: 6-week timepoint (for the intervention group and the control group)
|
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
Time Frame: 6-month follow-up timepoint (for the intervention group and the control group)
|
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
Time Frame: Baseline (for the intervention group and the control group)
|
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
Time Frame: 6-week timepoint (for the intervention group and the control group)
|
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
Time Frame: 6-month follow-up timepoint (for the intervention group and the control group)
|
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
Time Frame: Baseline (for the intervention group and the control group)
|
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
Time Frame: 6-week timepoint (for the intervention group and the control group)
|
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
Time Frame: 6-month follow-up timepoint (for the intervention group and the control group)
|
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
Time Frame: 6-week timepoint (for the intervention group only)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression as determined by the Centre for Epidemiological Studies depression (CES-D)
Time Frame: Baseline (for the intervention group and the control group)
|
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.
|
Baseline (for the intervention group and the control group)
|
|
Depression as determined by the Centre for Epidemiological Studies depression (CES-D)
Time Frame: 6-week timepoint (for the intervention group and the control group)
|
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.
|
6-week timepoint (for the intervention group and the control group)
|
|
Depression as determined by the Centre for Epidemiological Studies depression (CES-D)
Time Frame: 6-month follow-up timepoint (for the intervention group and the control group)
|
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.
|
6-month follow-up timepoint (for the intervention group and the control group)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David S Ditor, PhD, Brock University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Multiple Sclerosis
- Inflammation
- Spinal Cord Injuries
Other Study ID Numbers
- 22-337 - Ditor
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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