NCT05165238

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.6 years

First QC Date

December 17, 2021

Last Update Submit

September 19, 2023

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

  • Diet quality

    Diet quality will be measured via 4 day food journal

    end of intervention (4 weeks)

  • Diet quality

    Diet quality will be measured via 4 day food journal

    3 months post intervention

Study Arms (1)

Coaching program

EXPERIMENTAL

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.

Behavioral: Impact of four week coaching program on dietary habits

Interventions

Impact of four week coaching program on dietary habitsBEHAVIORAL

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

Coaching program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • If the subjects are outside of the age range they will not be able to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB

Birmingham, Alabama, 35094, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Brooks Wingo, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 17, 2021

First Posted

December 21, 2021

Study Start

January 10, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)