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Purpose

Multiple sclerosis (MS) is the leading cause of irreversible neurological disability among young women and the second leading cause of disability among young men in the U.S. Cardiometabolic risk factors including obesity and hyperlipidemia are common among people with MS, and these risk factors are associated with severity and frequency of MS relapses and disease progression. People with MS often experience symptoms of pain, fatigue, and depression, which make adhering to a healthy lifestyle difficult, as evidenced by the high rates of unhealthy behaviors including poor diet and physical inactivity among this group. Physical activity has reduced symptoms of MS and improved metabolic risk profiles, but little research has focused on the role of a dietary intervention combined with physical activity in this group. Therefore, the purpose of this study is to test the efficacy of a combined diet and physical activity intervention for reducing cardiometabolic risks and MS symptoms when compared to a physical activity intervention alone.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Relapsing-Remitting MS - On disease modifying treatment for 6 months - No relapse within the previous 30 days - BMI 25-55 kg/m2 - Self-identify as not currently meeting recommendations for healthy diet and physical activity - Ambulatory with or without assistance - Reliable access to the internet via computer or smartphone - Responsible for their personal food preparation or have input into the food prepared for them - Score indicating low cognitive functioning on the Telephone Interview for Cognitive Status assessment

Exclusion Criteria

  • Physician does not approve participation - Use of the following diabetes medications: Acetohexamide, Chlorpropamide (Diabinese), Tolbutamide (Orinase, Tol-Tab), Tolazamide (Tolinase), Glipizide (Glucotrol, Glucotrol XL, Metaglip), Glyburide (Micronase, DiaBeta, Glynase, Glucovance), Glimepiride (Amaryl), Humalog or lispro, Novolog or aspart, Apidra or glulisine, Regular (R) humulin or novolin, Velosulin (for use in the insulin pump), NPH (N), Lente (L), Ultralente (U), Lantus, Levemir or detemir, Humulin 70/30, Novolin 70/30, Novolog 70/30, Humulin 50/50, or Humalog mix 75/25 - Already on a specific diet meant to improve health - Heart attack, stroke, or heart bypass surgery less than 6 months ago - Pulmonary disease, cardiovascular disease or renal failure less than 6 months ago - Smoking - Cancer, HIV or liver/kidney disease - Inability to travel to Lakeshore for testing

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
BIPAMS 		All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
  • Behavioral: Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)
    This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
  • Behavioral: BIPAMS + Diet
    For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
Experimental
BIPAMS + Diet 		All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
  • Behavioral: BIPAMS + Diet
    For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.

More Details

Status
Terminated
Sponsor
University of Alabama at Birmingham

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.