Activity and Balanced Eating to Reduce Comorbidities and Symptoms of MS

NCT ID: NCT03808545

Last Updated: 2022-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-26
• Study Completion Date: 2020-03-19

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

BIPAMS + Diet

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Brooks C. Wingo, PhD

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lakeshore Foundation

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

P30DK056336

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300002096

Identifier Type: -

Identifier Source: org_study_id