Anti-inflammatory Diet Consultation for Those With Neuromuscular Disability

NCT ID: NCT05881122

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-05-30

Brief Summary

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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

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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).

Conditions

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Inflammation Spinal Cord Injuries Multiple Sclerosis Muscular Dystrophies Diet Habit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mad Dog Dietary Consultation Intervention group

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.

Group Type EXPERIMENTAL

Mad Dog Dietary Consultation

Intervention Type 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.

Control group

The controls received the recipes only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mad Dog Dietary Consultation

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brock University

OTHER

Sponsor Role lead

Responsible Party

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David Ditor

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David S Ditor, PhD

Role: PRINCIPAL_INVESTIGATOR

Brock University

Locations

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Brock University

St. Catharines, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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21-054 - Ditor

Identifier Type: -

Identifier Source: org_study_id

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