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临床试验/NCT05881122
NCT05881122已完成不适用

The Effects of an Anti-inflammatory Dietary Consultation on Self-efficacy, Adherence and Selected Health Outcomes: A Randomized Control Trial

Brock University2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Adherence to the anti-inflammatory diet

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Adherence to the anti-inflammatory diet

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

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%

Custom-designed task self-efficacy questionnaire

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

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

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

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.

次要结局

  • 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))
  • Neuropathic pain questionnaire (NPQ)(One month post-intervention (for the intervention group and the control group))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Ditor

Professor

Brock University

研究点 (2)

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