Clinical trial NCT03808545: Activity and Balanced Eating to Reduce Comorbidities and Symptoms of MS
Official title: Comprehensive Lifestyle Intervention for Reducing Cardiometabolic Risk and Symptom Burden in Adults With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-01-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: BMI Change
timeFrame: Baseline and16 weeks
measure: Waist Circumference Change
timeFrame: Baseline and 16 weeks
measure: Fat Mass Change
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Diastolic Blood Pressure Change
timeFrame: Baseline and 16 weeks
measure: Systolic Blood Pressure Change
timeFrame: Baseline and 16 weeks
measure: Glucose Change
timeFrame: Baseline and16 weeks
measure: Insulin Change
timeFrame: Baseline and16 weeks
measure: Triglycerides Change
timeFrame: Baseline and 16 weeks
measure: LDL-C Change
timeFrame: Baseline and16 weeks
measure: HDL-C Change
timeFrame: Baseline and 16 weeks
measure: Total Cholesterol Change
timeFrame: Baseline and 16 weeks
measure: Change in Fatigue Severity Scale
timeFrame: Baseline and16 weeks
measure: Change in Modified Fatigue Impact Scale
timeFrame: Baseline and 16 weeks
measure: Change in Depression Symptoms
timeFrame: Baseline and 16 weeks
measure: Change in Anxiety
timeFrame: Baseline and16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lakeshore Foundation
state: Alabama
Study officials:
References: