Comprehensive Lifestyle Intervention for Reducing Cardiometabolic Risk and Symptom Burden in Adults With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- BMI Change
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Cancer, HIV or liver/kidney disease
- •Inability to travel to Lakeshore for testing
结局指标
主要结局
BMI Change
时间窗: Baseline and16 weeks
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.
Fat Mass Change
时间窗: Baseline and 16 weeks
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.
Waist Circumference Change
时间窗: Baseline and 16 weeks
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.
次要结局
- Change in Depression Symptoms(Baseline and 16 weeks)
- Total Cholesterol Change(Baseline and 16 weeks)
- Change in Anxiety(Baseline and16 weeks)
- Glucose Change(Baseline and16 weeks)
- Insulin Change(Baseline and16 weeks)
- Systolic Blood Pressure Change(Baseline and 16 weeks)
- HDL-C Change(Baseline and 16 weeks)
- Diastolic Blood Pressure Change(Baseline and 16 weeks)
- Triglycerides Change(Baseline and 16 weeks)
- LDL-C Change(Baseline and16 weeks)
- Change in Fatigue Severity Scale(Baseline and16 weeks)
- Change in Modified Fatigue Impact Scale(Baseline and 16 weeks)
研究者
Brooks C. Wingo, PhD
Primary Investigator
University of Alabama at Birmingham