A Pilot Nutrition Program for Spinal Cord Injury and MS
Condition: Spinal Cord Injuries; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility of a 12-week pilot community-based
      nutrition program for individuals with spinal cord injury and multiple sclerosis, and to
      determine the effects of the nutrition program on body composition, inflammation, neuropathic
      pain, depression and quality of life.
    

Detailed description: 
      Spinal cord injury (SCI) and multiple sclerosis (MS) are both conditions characterized by
      chronic inflammation as indicated by elevated levels of circulating pro-inflammatory
      cytokines. These cytokines can have a wide array of negative impacts in the body. For
      example, pro-inflammatory cytokines can impair serotonin production and usage in the brain
      and thus increase the risk of depression. Likewise, they can sensitize nociceptors and
      increase the intensity and frequency of neuropathic pain. Recent work has shown that a
      3-month anti-inflammatory diet is not only effective in reducing pro-inflammatory cytokines,
      but also reduced self-reported depression and neuropathic pain, by approximately 55% and 40%,
      respectively (Allison and Ditor, 2015; Allison et al., 2016). These data are very promising
      since both depression and neuropathic pain are highly prevalent after SCI and MS, and current
      pharmacological treatments are only partially effective and associated with unwanted
      side-effects.

      Despite the highly encouraging results mentioned above, one year following the conclusion of
      the study participants were no longer adhering to the anti-inflammatory diet. Specifically,
      during the actual study, adherence to the diet was, on average 89% (70-100%), while at
      one-year follow-up, adherence fell to, on average 43% (36-53%), which was virtually the same
      as baseline eating habits (Allison and Ditor, 2018). Likewise, measures of depression went
      back to baseline as well. These follow-up data prompted a subsequent qualitative study in
      which former participants were interviewed as a means to identify the facilitators and
      barriers that affect one's ability to adhere to the anti-inflammatory diet (Bailey et al.,
      2018). This qualitative study is now being used to inform a nutrition program that is in the
      early stages of development at a wheelchair accessible exercise facility; Power Cord.

      The nutrition program will consist of 4 aspects:

        1. Once per week (Monday mornings), nutrition program members will come to Power Cord to
           pick up their box of ingredients for their meals that week (Monday to Friday). Recipe
           cards will accompany the ingredients, and enough food will be provided for 3 meals and 2
           snacks per day. The meals will be based on the anti-inflammatory diet mentioned above.
           The nutrition program will not provide ingredients for Saturdays and Sundays, for three
           reasons. First, research has shown that occasional "cheat meals" help with long term
           compliance to the diet. Second, members should eventually become self-sufficient and
           even wean themselves off the nutrition program (or reduce their involvement). Third,
           this reduces the cost of the program and will help with long term sustainability.

        2. To assist the members with meal preparation, there will also be 10-12 online videos that
           cover basic kitchen/cooking skills, how to prepare the meals in the program, how to shop
           for healthy foods at the grocery store, etc.

        3. At the beginning of the program each member will be provided with a few pieces of
           accessible kitchen equipment that will made food preparation and cooking much easier.
           The equipment includes, a 1 Second Slicer (to be used in place of a knife), a padded lap
           tray (to be used as a cutting surface on the lap instead of a counter), a toaster oven,
           light weight pots and pans, a Nutri Bullet Blender.

        4. Once per month, there will be a live cooking class.

      Before this nutrition program can be long-term and sustainable, a 12-week pilot program will
      be completed to help determine the eventual membership pricing and feasibility. This pilot
      will also be used to determine the effects of the diet on body composition, inflammation,
      neuropathic pain, depression and quality of life. This pilot program will include 15 existing
      Power Cord members; 5 with SCI and 5 with MS who will be in the diet group, and 5 individuals
      with SCI and MS who will serve as controls. Participants in the pilot program will only pay
      $100/month for their involvement, and this will include their kitchen equipment, food for the
      3-months, cooking classes and access to online content. The study and outcome measures
      described in this posting pertain to the 3-month pilot nutrition program.
    

Intervention name(s): Diet group
Intervention type(s): Other
Intervention description(s): The diet group will be involved in a 12-week pilot nutrition program that will be based on the anti-inflammatory diet previously studied by Allison and Ditor (2015).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment