Activity and Balanced Eating to Reduce Comorbidities and Symptoms of MS (ABC's of MS)

The University of Alabama at Birmingham

Status: Terminated

Conditions: Multiple Sclerosis

Treatments: Behavioral: BIPAMS + Diet; Behavioral: Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03808545

P30DK056336 (U.S. NIH Grant/Contract)

IRB-300002096

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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11 participants in 2 patient groups

BIPAMS

Active Comparator group

Description:

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.

Treatment:

Behavioral: Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)

BIPAMS + Diet

Experimental group

Description:

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.

Treatment:

Behavioral: BIPAMS + Diet