Activity and Balanced Eating to Reduce Comorbidities and Symptoms of M
Comprehensive Lifestyle Intervention for Reducing Cardiometabolic Risk and Symptom Burden in Adults With Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Lack of enrollment
What was tested
Treatment tested
- BIPAMS + Diet
Compared with
- Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)
Results by group
BMI Change
Baseline and16 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| BIPAMS | .60 kg/m2 | 1.36 (Standard Deviation) | 5 |
| BIPAMS + Diet | .49 kg/m2 | 1.3 (Standard Deviation) | 4 |
BIPAMS
BIPAMS + Diet
Waist Circumference Change
Baseline and 16 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| BIPAMS | .31 cm | 3.07 (Standard Deviation) | 5 |
| BIPAMS + Diet | .31 cm | 5.54 (Standard Deviation) | 4 |
BIPAMS
BIPAMS + Diet
Fat Mass Change
Baseline and 16 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| BIPAMS | 2.14 lb | 6.07 (Standard Deviation) | 5 |
| BIPAMS + Diet | .05 lb | 3.07 (Standard Deviation) | 4 |
BIPAMS
BIPAMS + Diet
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| BIPAMS | 6 | 0 (0.0%) | 0 |
| BIPAMS + Diet | 5 | 1 (20.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
BMI Change
Baseline and16 weeks
Waist Circumference Change
Baseline and 16 weeks
Fat Mass Change
Baseline and 16 weeks
Physical function
Other measures (12)
Diastolic Blood Pressure Change
Baseline and 16 weeks
Systolic Blood Pressure Change
Baseline and 16 weeks
Glucose Change
Baseline and16 weeks
Insulin Change
Baseline and16 weeks
Triglycerides Change
Baseline and 16 weeks
LDL-C Change
Baseline and16 weeks
HDL-C Change
Baseline and 16 weeks
Total Cholesterol Change
Baseline and 16 weeks
Change in Fatigue Severity Scale
Baseline and16 weeks
FatigueChange in Modified Fatigue Impact Scale
Baseline and 16 weeks
Fatigue
Who could take part
Relapsing MS · 18 to 65
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Feb 2019
Main results due
Mar 2020
Finished
Mar 2020
Results posted
Nov 2022