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Anti-inflammatory Diet Consultation for Those With Neuromuscular Disability

Primary Purpose

Inflammation, Spinal Cord Injuries, Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mad Dog Dietary Consultation
Sponsored by
Brock University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammation

Eligibility Criteria

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

Inclusion Criteria: To be eligible for this study, participants were required to be over 18 years of age, fluent in English and at least one year removed from either SCI or neurological diagnosis. All participants but one (who had muscular dystrophy) had either spinal cord injury (SCI) or multiple sclerosis (MS). Participants with SCI could have any level or severity of injury while participants with MS could have had any type of MS. Exclusion Criteria: Younger than 18 Not fluent in English No SCI or diagnosis of MS or muscular dystrophy

Sites / Locations

  • Brock University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mad Dog Dietary Consultation Intervention group

Control group

Arm Description

The intervention group received recipes for an anti-inflammatory diet and the 2-part consultation. The consultation consisted of a home-visit that included cooking and accessible kitchen equipment demonstrations, and an accompanied trip to the grocery store.

The controls received the recipes only.

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 6-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain amounts at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 6 and the maximum score is 42, 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 6-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain amounts at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 6 and the maximum score is 42, 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 6-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain amounts at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 6 and the maximum score is 42, 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 7-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 7 and the maximum score is 49, 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 7-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 7 and the maximum score is 49, 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 7-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 7 and the maximum score is 49, 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. These values are then combined to calculate each participant's adherence rate with the formula: [(number of servings eaten that were allowed/total servings eaten) x 100]. Adherence rate will be expressed as a percentage. For example, if the participant ate 50 servings of food over 7 days, with 45 of those servings allowed by the anti-inflammatory diet and 5 servings not allowed (cheats), then the adherence rate would be calculated as: Adherence = 45/50 x 100 Adherence = 90%

Secondary Outcome Measures

Neuropathic pain questionnaire (NPQ)
Neuropathic pain as determined by the Neuropathic Pain Questionnaire (NPQ). The questionnaire consists of 32 items pertaining to three unique categories including sensory items, affective items, and sensitivity items. Sensory items are those related to the specific type and severity of pain felt (e.g., degree of burning, stabbing, throbbing), affective items relate to how the pain affects the participant in daily life (e.g., how irritating is your usual pain?) and sensitivity items related to how various stimuli may act to increase pain (e.g., increased pain due to heat). Participants are asked to rate their pain for each item numerically on a scale from 0-100 whereby 0 indicated the complete absence of pain and 100 indicated the worst pain imaginable. Scores from each of the three categories are averaged. Thus, the minimum score for each category is 0 and the maximum score for each category is 100, which higher scores indicating worse pain.
Neuropathic pain questionnaire (NPQ)
Neuropathic pain as determined by the Neuropathic Pain Questionnaire (NPQ). The questionnaire consists of 32 items pertaining to three unique categories including sensory items, affective items, and sensitivity items. Sensory items are those related to the specific type and severity of pain felt (e.g., degree of burning, stabbing, throbbing), affective items relate to how the pain affects the participant in daily life (e.g., how irritating is your usual pain?) and sensitivity items related to how various stimuli may act to increase pain (e.g., increased pain due to heat). Participants are asked to rate their pain for each item numerically on a scale from 0-100 whereby 0 indicated the complete absence of pain and 100 indicated the worst pain imaginable. Scores from each of the three categories are averaged. Thus, the minimum score for each category is 0 and the maximum score for each category is 100, which higher scores indicating worse pain.
Depression as determined by the Centre for Epidemiological Studies depression (CES-D) questionnaire
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) questionnaire
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
April 17, 2023
Last Updated
May 29, 2023
Sponsor
Brock University
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1. Study Identification

Unique Protocol Identification Number
NCT05881122
Brief Title
Anti-inflammatory Diet Consultation for Those With Neuromuscular Disability
Official Title
The Effects of an Anti-inflammatory Dietary Consultation on Self-efficacy, Adherence and Selected Health Outcomes: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

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
This study investigated the effects of a 2-part dietary consultation on adherence to an anti-inflammatory diet in individuals with neuromuscular disability. The effects on self-efficacy for adhering to the diet as well as neuropathic pain and depression one month post-consult were also determined.
Detailed Description
This study investigated the effects of a 2-part dietary consultation (the Mad Dog consult) on adherence to an anti-inflammatory diet (the Mad Dog diet) in individuals (N=11) with spinal cord injury, multiple sclerosis and muscular dystrophy. participants were randomly allocated into either the intervention group (n=7) or the control group (n=4). The Mad Dog consultation was delivered in two parts over consecutive days. Part I entailed an accompanied trip to the participant's preferred grocery store in order to show the participant where selected foods could be found, how to read nutrition labels so that acceptable substitutions to the Mad Dog ingredients could be made, and how to shop for value when choices are presented. Part II of the consultation occurred in the participant's home and focused on meal preparation and kitchen accessibility, as well as a brief overview regarding the negative consequences of chronic inflammation, and the positive effects of adopting an anti-inflammatory diet. Accordingly, the researchers traveled to the participant's home and prepared two sample dinner meals for the participant in an interactive and instructional format. The researchers also brought selected pieces of accessible cooking equipment (designed for use in those with reduced hand function) which were demonstrated during the meal preparation. Participants were not given the equipment to keep, but they were instructed where to buy the equipment online if they found it beneficial. Questions and discussion were highly encouraged throughout the consultation and materials were left with the participants allowing them to easily review and reference information that was covered during the meeting. Specifically, participants were given a booklet with 28 compliant recipes, additional snack ideas and shopping tips along with a brochure summarizing the consult. The combined length of the consult was approximately 90-120 minutes. Lastly, the Mad Dog consultation also included a virtual group, where participants could share and discuss anti-inflammatory recipes (that may complement the recipes in the Mad Dog diet) and engage in social support. Researchers were part of the group to oversee discussion but did not participate. The control group only received the Mad Dog diet recipes, but did not take part in the consultation. Adherence to the Mad Dog diet was determined by 7-day food logs before the intervention and at one month post-intervention. Task and barrier self-efficacy were determined by questionnaire at baseline (immediately after viewing the Mad Dog Diet), immediately after the consultation (in the intervention group only ) and at one month post-intervention (in both groups). Neuropathic pain and depression were determined by the Neuropathic Pain Questionnaire and the Centre for Epidemiological Studies Depression (CES-D) questionnaire at baseline and at one month post-intervention (in both groups).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Spinal Cord Injuries, Multiple Sclerosis, Muscular Dystrophies, Diet Habit

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mad Dog Dietary Consultation Intervention group
Arm Type
Experimental
Arm Description
The intervention group received recipes for an anti-inflammatory diet and the 2-part consultation. The consultation consisted of a home-visit that included cooking and accessible kitchen equipment demonstrations, and an accompanied trip to the grocery store.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The controls received the recipes only.
Intervention Type
Behavioral
Intervention Name(s)
Mad Dog Dietary Consultation
Intervention Description
The Mad Dog consultation was delivered in two parts over consecutive days. Part I entailed an accompanied trip to the participant's preferred grocery store to show the participant where selected foods could be found, how to read nutrition labels so that acceptable substitutions to the Mad Dog ingredients could be made, and how to shop for value when choices are presented. Part II of the consultation occurred in the participant's home and focused on meal preparation and kitchen accessibility, as well as a brief overview regarding the negative consequences of chronic inflammation, and the positive effects of adopting an anti-inflammatory diet. Questions and discussion were highly encouraged throughout the consultation and materials were left with the participants allowing them to easily review and reference information that was covered during the meeting. Specifically, participants were given 28 compliant recipes, additional snack ideas and shopping tips along with a consult summary.
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 6-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain amounts at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 6 and the maximum score is 42, 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 6-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain amounts at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 6 and the maximum score is 42, and higher scores indicate greater self-efficacy.
Time Frame
Immediately post-intervention (in the intervention group only)
Title
Custom-designed task self-efficacy questionnaire
Description
Confidence in one's abilities to adhere to the anti-inflammatory diet. This is a 6-item questionnaire that asks how confident participants are about adhering to the diet for certain amounts of time at certain amounts at certain percentages of adherence. Each item is scored from 1 (not confident at all) to 7 (completely confident). The minimum score is 6 and the maximum score is 42, and higher scores indicate greater self-efficacy.
Time Frame
One month post-intervention (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 7-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 7 and the maximum score is 49, 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 7-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 7 and the maximum score is 49, and higher scores indicate greater self-efficacy.
Time Frame
Immediately post-intervention (in the intervention group only).
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 7-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 7 and the maximum score is 49, and higher scores indicate greater self-efficacy.
Time Frame
One month post-intervention (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. These values are then combined to calculate each participant's adherence rate with the formula: [(number of servings eaten that were allowed/total servings eaten) x 100]. Adherence rate will be expressed as a percentage. For example, if the participant ate 50 servings of food over 7 days, with 45 of those servings allowed by the anti-inflammatory diet and 5 servings not allowed (cheats), then the adherence rate would be calculated as: Adherence = 45/50 x 100 Adherence = 90%
Time Frame
One month post-intervention (for the intervention group and the control group)
Secondary Outcome Measure Information:
Title
Neuropathic pain questionnaire (NPQ)
Description
Neuropathic pain as determined by the Neuropathic Pain Questionnaire (NPQ). The questionnaire consists of 32 items pertaining to three unique categories including sensory items, affective items, and sensitivity items. Sensory items are those related to the specific type and severity of pain felt (e.g., degree of burning, stabbing, throbbing), affective items relate to how the pain affects the participant in daily life (e.g., how irritating is your usual pain?) and sensitivity items related to how various stimuli may act to increase pain (e.g., increased pain due to heat). Participants are asked to rate their pain for each item numerically on a scale from 0-100 whereby 0 indicated the complete absence of pain and 100 indicated the worst pain imaginable. Scores from each of the three categories are averaged. Thus, the minimum score for each category is 0 and the maximum score for each category is 100, which higher scores indicating worse pain.
Time Frame
Baseline (for the intervention group and the control group)
Title
Neuropathic pain questionnaire (NPQ)
Description
Neuropathic pain as determined by the Neuropathic Pain Questionnaire (NPQ). The questionnaire consists of 32 items pertaining to three unique categories including sensory items, affective items, and sensitivity items. Sensory items are those related to the specific type and severity of pain felt (e.g., degree of burning, stabbing, throbbing), affective items relate to how the pain affects the participant in daily life (e.g., how irritating is your usual pain?) and sensitivity items related to how various stimuli may act to increase pain (e.g., increased pain due to heat). Participants are asked to rate their pain for each item numerically on a scale from 0-100 whereby 0 indicated the complete absence of pain and 100 indicated the worst pain imaginable. Scores from each of the three categories are averaged. Thus, the minimum score for each category is 0 and the maximum score for each category is 100, which higher scores indicating worse pain.
Time Frame
One month post-intervention (for the intervention group and the control group)
Title
Depression as determined by the Centre for Epidemiological Studies depression (CES-D) questionnaire
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) questionnaire
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
One month post-intervention (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 were required to be over 18 years of age, fluent in English and at least one year removed from either SCI or neurological diagnosis. All participants but one (who had muscular dystrophy) had either spinal cord injury (SCI) or multiple sclerosis (MS). Participants with SCI could have any level or severity of injury while participants with MS could have had any type of MS. Exclusion Criteria: Younger than 18 Not fluent in English No SCI or diagnosis of MS or muscular dystrophy
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

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

Anti-inflammatory Diet Consultation for Those With Neuromuscular Disability

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