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Behavioral Telehealth for Obesity in Multiple Sclerosis (MoDEMS Trial)

N/A
Waitlist Available
Led By Jared Bruce, PhD
Research Sponsored by Jared Bruce
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No contraindications to exercise (answer 'no' to all 7 questions on Physical Activity Readiness Questionnaire; PAR-Q114) or physician approval to exercise if answer 'yes' to 1 or more questions on PAR-Q
No history of insulin dependent diabetes or serious pulmonary/cardiac conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

MoDEMS Trial Summary

This trial will investigate a weight loss intervention for obese patients with MS. Half of the patients will be randomly assigned to 24 weekly hour-long group weight loss sessions and 6 monthly individual sessions; half will be assigned to a brief education/Treatment as Usual (TAU) control condition.

Eligible Conditions
  • Multiple Sclerosis
  • Obesity

MoDEMS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must not have any health issues that would make exercise unsafe, or you need a doctor's permission to exercise if you have any health issues.
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You do not have a history of needing insulin for diabetes, or serious lung or heart problems.
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You have not had a confirmed return of your medical condition in the past month.
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Your weight has stayed about the same, with no big changes, for the past 3 months before joining the study.
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You don't have a serious mental illness like schizophrenia, current thoughts of harming yourself, or current binge eating disorder. These conditions may not work well with the weight loss program.
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You have been diagnosed with a specific type of multiple sclerosis, confirmed by medical records.
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You are between 18 and 70 years old.

MoDEMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Weight Loss
Secondary outcome measures
6 Minute Walk
Hospital Anxiety and Depression Scale
MS Quality of Life Inventory
+1 more
Other outcome measures
Actigraphy
DXA

MoDEMS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group Telehealth ObesityExperimental Treatment1 Intervention
Participants will receive 24 weekly group phone counseling sessions and monthly individual sessions that encourage healthy eating and exercise. The planned intervention is guided by a social-cognitive framework and includes self-monitoring, goal setting, stimulus control, social support, cognitive reframing of unrealistic and negative thoughts, and developing positive expectancies for long-term weight control. The primary objective is to decrease caloric intake and increase physical activity to produce weight loss of approximately .4 to.9 kg per week, with the study goal of 10% reduction from baseline.
Group II: Treatment as UsualActive Control2 Interventions
Following baseline assessment, patients randomized to the TAU arm will receive monthly dietary pamphlets and web-based obesity prevention educational materials from the U.S. Office of Disease Prevention and Health Promotion (https://healthfinder.gov/HealthTopics/). After the 6-month assessment, TAU patients will begin the weight loss intervention arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
behavioral telehealth
2020
N/A
~70

Find a Location

Who is running the clinical trial?

Jared BruceLead Sponsor
National Multiple Sclerosis SocietyOTHER
95 Previous Clinical Trials
9,413 Total Patients Enrolled
93 Trials studying Multiple Sclerosis
9,059 Patients Enrolled for Multiple Sclerosis
University of Kansas Medical CenterOTHER
458 Previous Clinical Trials
169,018 Total Patients Enrolled
5 Trials studying Multiple Sclerosis
299 Patients Enrolled for Multiple Sclerosis

Media Library

Telehealth Obesity Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04255953 — N/A
Multiple Sclerosis Research Study Groups: Treatment as Usual, Group Telehealth Obesity
Multiple Sclerosis Clinical Trial 2023: Telehealth Obesity Intervention Highlights & Side Effects. Trial Name: NCT04255953 — N/A
Telehealth Obesity Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04255953 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to volunteer for this medical experiment?

"To qualify for this clinical trial, individuals must have a diagnosis of multiple sclerosis and be between the ages of 18 and 70. At present, approximately seventy participants are being accepted into the study."

Answered by AI

Is it possible for patients to register for this experiment at the present moment?

"According to clinicaltrials.gov, enrollment for this trial is currently closed. The initial posting date was August 1st 2020 and the most recent update was November 1st 2022. Alternately, there are presently 1344 other trials actively recruiting participants across the US."

Answered by AI

Does this clinical trial admit individuals over forty years of age?

"This clinical trial is enrolling patients, aged 18-70 years old."

Answered by AI
~15 spots leftby Mar 2025