Impact Program for Multiple Sclerosis

NCT ID: NCT05165238

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2023-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to explore the effects of a four week diet coaching program on pain, fatigue, mood, and dietary habits among adults with multiple sclerosis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Multiple Sclerosis (MS) is the most common chronic disabling central nervous system (CNS) disease in young adults, affecting 1 in 1,000 people in Western countries. Disproportionate and unpredictable impacts of co-morbid health conditions enhances the needs for comprehensive MS management and wellness strategies.

However, comprehensive care is limited, forcing many people to neglect critical aspects of their wellness. This creates a profound need for health and wellness programs that provide education, connection, and activation.

Research shows a consistent need for more access to reliable information regarding symptoms, management, access to healthcare professionals, and rehabilitation. There is also a primary unmet need for more information on exercise, nutrition, insurance, transportation, and employment.

People living with MS often receive more information from advocacy organizations than their MS nurse or neurologist. Decreased access to healthcare professionals since the COVID-19 pandemic has heightened the need for credible information from organizations like Can Do MS. Over the past year, Can Do MS has seen significant growth in virtual program attendance, with participant identifying "learning new information" as a critical objective.

A multipronged approach utilizing auditory, visual, and kinesthetic learning styles is the preferred method for delivering information. There is also a need to appeal to multiple sensory channels through complimentary mediums (e.g. video, audio, written materials, tactile activities).

We will study the effects of the four week coaching program on dietary patterns in MS patients. This will be done through surveys the participants will complete through Qulatrics.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Coaching program

Participants will complete a 4-week coaching program in an on-line group setting. The purpose of the program will be to help participants change dietary behaviors via a small changes approach.

Group Type EXPERIMENTAL

Impact of four week coaching program on dietary habits

Intervention Type BEHAVIORAL

A registered dietitian will provide dietary coaching via online groups to participants.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Impact of four week coaching program on dietary habits

A registered dietitian will provide dietary coaching via online groups to participants.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

All participants will be adults ages 18 to 65 diagnosed with any form of MS. Caregivers are also invited to attend the program if they would like to. No restrictions will be made based on sex, gender or other condition.

Exclusion Criteria

* If the subjects are outside of the age range they will not be able to participate.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brooks C. Wingo, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Brooks Wingo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UAB

Birmingham, Alabama, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

300008553

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Framingham State Food Study
NCT02068885 COMPLETED NA
Physiological Reaction After Food Intake
NCT06548165 ACTIVE_NOT_RECRUITING NA
Medifast 5 & 1 Plan
NCT01211301 COMPLETED NA
The Mixed Meal Challenge Study
NCT05087823 COMPLETED NA