Anti-inflammatory Diet Consultation for Those With Neuromuscular Disability

NCT05881122 | Completed

• 1 other identifier: 21-054 - Ditor
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Spinal Cord Injuries; Multiple Sclerosis; Muscular Dystrophies; Diet Habit

Outcome Measures

Primary Outcomes (8)

• 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.

  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 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.

  Immediately post-intervention (in the intervention group only)

• 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.

  One month post-intervention (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 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.

  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 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.

  Immediately post-intervention (in the intervention group only).

• 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.

  One month post-intervention (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. 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%

  One month post-intervention (for the intervention group and the control group)

Secondary Outcomes (4)

• Neuropathic pain questionnaire (NPQ)

  Baseline (for the intervention group and the control group)

• Neuropathic pain questionnaire (NPQ)

  One month post-intervention (for the intervention group and the control group)

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

  Baseline (for the intervention group and the control group)

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

  One month post-intervention (for the intervention group and the control group)

Study Arms (2)

Mad Dog Dietary Consultation Intervention group

EXPERIMENTAL

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.

Behavioral: Mad Dog Dietary Consultation

Control group

NO INTERVENTION

The controls received the recipes only.

Interventions

Mad Dog Dietary Consultation BEHAVIORAL

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.

Mad Dog Dietary Consultation Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Brock University: lead

Study Sites (1)

Brock University

St. Catharines, Ontario, L2S 3A1, Canada

Location

MeSH Terms

Conditions

Inflammation; Spinal Cord Injuries; Multiple Sclerosis; Muscular Dystrophies; Feeding Behavior

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior, Animal; Behavior

Study Officials

• David S Ditor, PhD

  Brock University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 31, 2023
• Study Start: November 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 30, 2022
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)