Activity and Balanced Eating to Reduce Comorbidities and Symptoms of MS

Not Applicable

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS); Behavioral: BIPAMS + Diet

• Registration Number: NCT03808545
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-09
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-17
• Study Start: 2019-02-26
• Primary Completion: 2020-03-19
• Study Completion: 2020-03-19
• Results First Submitted: 2022-07-20
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-16
• Last Update Submitted: 2022-11-16
• Results First Posted: 2022-11-18
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIPAMS	Behavioral Intervention for Physical Activity in Multiple Sclerosis (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.
BIPAMS + Diet	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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
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.
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
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.
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Lakeshore Foundation; 🇺🇸 Birmingham, Alabama, United States