Activity and Balanced Eating to Reduce Comorbidities and Symptoms of MS

Study Overview
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Brief Summary
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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.

Official Title
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Comprehensive Lifestyle Intervention for Reducing Cardiometabolic Risk and Symptom Burden in Adults With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)
* Behavioral: BIPAMS + Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BIPAMS<br>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)<br>* 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.<br>|
| Experimental: BIPAMS + Diet<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI Change | BMI will be calculated using the formula weight/height2 (kg/m^2). Height will be measured with participants standing against the wall. Weight will be assessed using a digital scale. BMI change will be calculated the difference between 16 week BMI and baseline BMI. | Baseline and16 weeks | 
| Waist Circumference Change | Waist circumference will be measured twice at the level of the umbilicus after normal expiration, with the participant standing. If the two values differ by >1 cm, a third measurement will be taken and the results of the two or three trials averaged. Waist circumference change will be calculated as the difference between 16 week waist circumference and baseline waist circumference. | Baseline and 16 weeks | 
| Fat Mass Change | Participants will undergo a total body scan measuring total body composition on a Lunar iDXA with enCORE software version 13.6 (GE Healthcare, Chicago, IL). Fat mass (FM) change will be calculated the difference between 16 week FM and baseline FM. | Baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Blood Pressure Change | Diastolic blood pressure (DBP) will be obtained using a sphygmomanometer. DBP will be measured twice, with a resting time of 1 minute in between each measurement. The results of the two trials will be averaged. DBP change will be calculated as the difference between 16 week DBP and baseline DBP. | Baseline and 16 weeks | 
| Systolic Blood Pressure Change | Systolic blood pressure (BP) will be obtained using a sphygmomanometer. SBP will be measured twice, with a resting time of 1 minute in between each measurement. The results of the two trials will be averaged. SBP change will be calculated as the difference between 16 week SBP and baseline SBP. | Baseline and 16 weeks | 
| Glucose Change | Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Glucose, along with other blood measures, will be assessed from this blood sample. Glucose change will be calculated as the difference between 16 week glucose and baseline glucose. | Baseline and16 weeks | 
| Insulin Change | Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Insulin, along with other blood measures, will be assessed from this blood sample. Insulin change will be calculated the difference between 16 week insulin and baseline insulin. | Baseline and16 weeks | 
| Triglycerides Change | Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Triglycerides, along with other blood measures, will be assessed from this blood sample. Triglyceride change will be calculated as the difference between 16 week triglycerides and baseline triglycerides. | Baseline and 16 weeks | 
| LDL-C Change | Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. LDL-C, along with other blood measures, will be assessed from this blood sample. LDL-C change will be calculated as the difference between 16 week LDL-C and baseline LDL-C. | Baseline and16 weeks | 
| HDL-C Change | Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. HDL-C, along with other blood measures, will be assessed from this blood sample. HDL-C change will be calculated the difference between 16 week HDL-C and baseline HDL-C. | Baseline and 16 weeks | 
| Total Cholesterol Change | Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Total cholesterol (TC), along with other blood measures, will be assessed from this blood sample. TC change will be calculated as the difference between 16 week TC and baseline TC. | Baseline and 16 weeks | 
| Change in Fatigue Severity Scale | Measured by the Fatigue Severity Scale (FSS). The total score is the sum of the 9 items. The range for scoring is 9-63, with higher scores indicating greater fatigue severity. Change in fatigue will be calculated as the difference between 16-week FSS and baseline FSS. | Baseline and16 weeks | 
| Change in Modified Fatigue Impact Scale | Measured by the Modified Fatigue Impact Scale (MFIS). The total score is the sum of the 5 items. The range for scoring is 0-20, with higher scores indicating greater fatigue. Change in fatigue will be calculated as the difference between 16-week MFIS and baseline MFIS. | Baseline and 16 weeks | 
| Change in Depression Symptoms | Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7 item subscales. The total score is the sum of the 7 items from each subscale, and ranges from 0- 21 for the depression subscale. Higher scores in the depression subscale questions indicates greater levels of depression. Change in depression symptoms will be calculated as the difference between 16-week HADS depression subscale and baseline HADS depression subscale. Minimum score: 0; Maximum Score Depression subscale: 21 | Baseline and 16 weeks | 
| Change in Anxiety | Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7 item subscales. The total score is the sum of the 7 items from each subscale, and ranges from 0- 21 for the anxiety subscale. Higher scores in the anxiety subscale questions indicates greater levels of anxiety. Change in anxiety will be calculated as the difference between 16-week HADS anxiety subscale and baseline HADS anxiety subscale. Minimum score: 0; Maximum score anxiety subscale: 21 | Baseline and16 weeks |