Clinical trial NCT05881122: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Spinal Cord Injuries
Multiple Sclerosis
Muscular Dystrophies
Diet Habit
Lead sponsor: Brock University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Custom-designed task self-efficacy questionnaire
timeFrame: Baseline (for the intervention group and the control group)
measure: Custom-designed task self-efficacy questionnaire
timeFrame: Immediately post-intervention (in the intervention group only)
measure: Custom-designed task self-efficacy questionnaire
timeFrame: One month post-intervention (for the intervention group and the control group)
measure: Custom-designed barrier self-efficacy questionnaire
timeFrame: Baseline (for the intervention group and the control group).
measure: Custom-designed barrier self-efficacy questionnaire
timeFrame: Immediately post-intervention (in the intervention group only).
measure: Custom-designed barrier self-efficacy questionnaire
timeFrame: One month post-intervention (for the intervention group and the control group)
measure: Adherence to the anti-inflammatory diet
timeFrame: Baseline (for the intervention group and the control group)
measure: Adherence to the anti-inflammatory diet
timeFrame: One month post-intervention (for the intervention group and the control group)
Secondary outcomes:
measure: Neuropathic pain questionnaire (NPQ)
timeFrame: Baseline (for the intervention group and the control group)
measure: Neuropathic pain questionnaire (NPQ)
timeFrame: One month post-intervention (for the intervention group and the control group)
measure: Depression as determined by the Centre for Epidemiological Studies depression (CES-D) questionnaire
timeFrame: Baseline (for the intervention group and the control group)
measure: Depression as determined by the Centre for Epidemiological Studies depression (CES-D) questionnaire
timeFrame: One month post-intervention (for the intervention group and the control group)
Other outcomes:
Locations:
city: St. Catharines
country: Canada
facility: Brock University
state: Ontario
Study officials:
affiliation: Brock University
name: David S Ditor, PhD
role: PRINCIPAL_INVESTIGATOR
References: