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

Primary Purpose

Spinal Cord Injuries, Multiple Sclerosis, Diet, Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mad Dog cooking class series
Sponsored by
Brock University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brock University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mad Dog cooking class intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 29, 2023
Last Updated
July 6, 2023
Sponsor
Brock University
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1. Study Identification

Unique Protocol Identification Number
NCT05934968
Brief Title
Mad Dog Cooking Class Series: Effects on Dietary Self-efficacy, Eating Behaviors and Health Outcomes
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brock University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Multiple Sclerosis, Diet, Healthy, Inflammation, Depression, Adherence, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mad Dog cooking class intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will be given the Mad Dog recipes but will not take part in the Mad Dog cooking class series.
Intervention Type
Other
Intervention Name(s)
Mad Dog cooking class series
Intervention Description
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.
Primary Outcome Measure Information:
Title
Custom-designed task self-efficacy questionnaire
Description
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.
Time Frame
Baseline (for the intervention group and the control group)
Title
Custom-designed task self-efficacy questionnaire
Description
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.
Time Frame
6-week timepoint (for the intervention group and the control group)
Title
Custom-designed task self-efficacy questionnaire
Description
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.
Time Frame
6-month follow-up timepoint (for the intervention group and the control group)
Title
Custom-designed barrier self-efficacy questionnaire
Description
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.
Time Frame
Baseline (for the intervention group and the control group)
Title
Custom-designed barrier self-efficacy questionnaire
Description
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.
Time Frame
6-week timepoint (for the intervention group and the control group)
Title
Custom-designed barrier self-efficacy questionnaire
Description
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.
Time Frame
6-month follow-up timepoint (for the intervention group and the control group)
Title
Adherence to the anti-inflammatory diet
Description
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.
Time Frame
Baseline (for the intervention group and the control group)
Title
Adherence to the anti-inflammatory diet
Description
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.
Time Frame
6-week timepoint (for the intervention group and the control group)
Title
Adherence to the anti-inflammatory diet
Description
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.
Time Frame
6-month follow-up timepoint (for the intervention group and the control group)
Title
Custom-designed consumer satisfaction questionnaire
Description
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.
Time Frame
6-week timepoint (for the intervention group only)
Secondary Outcome Measure Information:
Title
Depression as determined by the Centre for Epidemiological Studies depression (CES-D)
Description
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.
Time Frame
Baseline (for the intervention group and the control group)
Title
Depression as determined by the Centre for Epidemiological Studies depression (CES-D)
Description
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.
Time Frame
6-week timepoint (for the intervention group and the control group)
Title
Depression as determined by the Centre for Epidemiological Studies depression (CES-D)
Description
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.
Time Frame
6-month follow-up timepoint (for the intervention group and the control group)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David S Ditor, PhD
Phone
905-688-5550
Ext
5338
Email
dditor@brocku.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Ditor, PhD
Organizational Affiliation
Brock University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brock University
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 3A1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David S Ditor, PhD
Phone
905-688-5550
Ext
5338
Email
dditor@brocku.ca

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Available upon reasonable request to the Principal Investigator

Learn more about this trial

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

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