Activity and Balanced Eating to Reduce Comorbidities and Symptoms of MS

NCT03808545 | Terminated Results

• 2 other identifiers: IRB-300002096P30DK056336
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and16 weeks

• 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.

  Baseline and 16 weeks

• 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.

  Baseline and 16 weeks

Secondary Outcomes (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

Study Arms (2)

BIPAMS

ACTIVE COMPARATOR

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: Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)

BIPAMS + Diet

EXPERIMENTAL

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.

Behavioral: BIPAMS + Diet

Interventions

Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS) 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

BIPAMS + Diet 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.

BIPAMS + Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Lakeshore Foundation

Birmingham, Alabama, 35209, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Behavior Therapy; Exercise; Diet

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Early termination was due to inability to recruit sufficient participants.

Results Point of Contact

• Title: Brooks Wingo, Associate Professor
• Organization: University of Alabama at Birmingham

bcwingo@uab.edu

2059345982

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: January 17, 2019
• Study Start: February 26, 2019
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: November 18, 2022
• Results First Posted: November 18, 2022

Record last verified: 2022-11

Locations

US (1)