Multiple Sclerosis
Conditions
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.
Interventions
BEHAVIORALBehavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)
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.
BEHAVIORALBIPAMS + Diet
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI Change | 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. |
| Waist Circumference Change | 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. |
| Fat Mass Change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Change | Baseline and16 weeks | 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. |
| Triglycerides Change | Baseline and 16 weeks | 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. |
| LDL-C Change | Baseline and16 weeks | 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. |
| HDL-C Change | Baseline and 16 weeks | 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. |
| Insulin Change | Baseline and16 weeks | 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. |
| Change in Fatigue Severity Scale | Baseline and16 weeks | 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. |
| Change in Modified Fatigue Impact Scale | Baseline and 16 weeks | 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. |
| Change in Depression Symptoms | Baseline and 16 weeks | 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 |
| Change in Anxiety | Baseline and16 weeks | 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 |
| Total Cholesterol Change | Baseline and 16 weeks | 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. |
| Diastolic Blood Pressure Change | Baseline and 16 weeks | 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. |
| Systolic Blood Pressure Change | Baseline and 16 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BIPAMS 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 Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): 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. | 5 |
| BIPAMS + Diet 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.
BIPAMS + Diet: 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. | 4 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | BIPAMS | BIPAMS + Diet | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 1 / 5 |
| serious Total, serious adverse events | 0 / 6 | 1 / 5 |
Outcome results
Primary
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.
Time frame: Baseline and16 weeks
Population: Only study completers were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | BMI Change | .60 kg/m2 | Standard Deviation 1.36 |
| BIPAMS + Diet | BMI Change | .49 kg/m2 | Standard Deviation 1.3 |
Primary
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.
Time frame: Baseline and 16 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | Fat Mass Change | 2.14 lb | Standard Deviation 6.07 |
| BIPAMS + Diet | Fat Mass Change | .05 lb | Standard Deviation 3.07 |
Primary
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.
Time frame: Baseline and 16 weeks
Population: Study completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | Waist Circumference Change | .31 cm | Standard Deviation 3.07 |
| BIPAMS + Diet | Waist Circumference Change | .31 cm | Standard Deviation 5.54 |
Secondary
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
Time frame: Baseline and16 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | Change in Anxiety | 0.40 score on a scale | Standard Deviation 2.61 |
| BIPAMS + Diet | Change in Anxiety | -2.00 score on a scale | Standard Deviation 1.41 |
Secondary
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
Time frame: Baseline and 16 weeks
Population: Completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | Change in Depression Symptoms | 2.40 score on a scale | Standard Deviation 2.19 |
| BIPAMS + Diet | Change in Depression Symptoms | .25 score on a scale | Standard Deviation 0.96 |
Secondary
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.
Time frame: Baseline and16 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | Change in Fatigue Severity Scale | 1.20 score on a scale | Standard Deviation 5.63 |
| BIPAMS + Diet | Change in Fatigue Severity Scale | 4.00 score on a scale | Standard Deviation 9.24 |
Secondary
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.
Time frame: Baseline and 16 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | Change in Modified Fatigue Impact Scale | .40 score on a scale | Standard Deviation 7.57 |
| BIPAMS + Diet | Change in Modified Fatigue Impact Scale | -2.50 score on a scale | Standard Deviation 13.72 |
Secondary
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.
Time frame: Baseline and 16 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | Diastolic Blood Pressure Change | -2.20 mmHG | Standard Deviation 9.6 |
| BIPAMS + Diet | Diastolic Blood Pressure Change | .00 mmHG | Standard Deviation 5.72 |
Secondary
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.
Time frame: Baseline and16 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | Glucose Change | -3.40 mg/dl | Standard Deviation 7.67 |
| BIPAMS + Diet | Glucose Change | .00 mg/dl | Standard Deviation 14.31 |
Secondary
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.
Time frame: Baseline and 16 weeks
Population: Only completers were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | HDL-C Change | -6.40 mg/dL | Standard Deviation 6.95 |
| BIPAMS + Diet | HDL-C Change | 1.00 mg/dL | Standard Deviation 7.44 |
Secondary
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.
Time frame: Baseline and16 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | Insulin Change | -2.76 microUnits/mL | Standard Deviation 4 |
| BIPAMS + Diet | Insulin Change | -2.80 microUnits/mL | Standard Deviation 11.14 |
Secondary
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.
Time frame: Baseline and16 weeks
Population: Completers only; BIPAMS group outlier lab value (n=1) was excluded from analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | LDL-C Change | -17.40 mg/dl | Standard Deviation 5.97 |
| BIPAMS + Diet | LDL-C Change | 10.50 mg/dl | Standard Deviation 20.69 |
Secondary
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.
Time frame: Baseline and 16 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | Systolic Blood Pressure Change | -6.20 mmHg | Standard Deviation 8.93 |
| BIPAMS + Diet | Systolic Blood Pressure Change | -4.25 mmHg | Standard Deviation 14.77 |
Secondary
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.
Time frame: Baseline and 16 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | Total Cholesterol Change | -12.00 mg/dl | Standard Deviation 19.81 |
| BIPAMS + Diet | Total Cholesterol Change | 9.00 mg/dl | Standard Deviation 29.47 |
Secondary
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.
Time frame: Baseline and 16 weeks
Population: Completers only; BIPAMS group outlier lab value (n=1) was excluded from analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIPAMS | Triglycerides Change | 4.50 mg/dl | Standard Deviation 14.2 |
| BIPAMS + Diet | Triglycerides Change | -12.50 mg/dl | Standard Deviation 14.53 |