Multiple SclerosisMoDEMSNCT04255953
Development of a Telehealth Obesity Intervention for Patients With MS: Modifying Diet and Exercise in MS
A study testing behavioral telehealth and Treatment as Usual in people with Multiple Sclerosis and Obesity, run by Jared Bruce at 1 site in United States.
Trial summary
We will tailor a telehealth obesity intervention for obese patients with MS (figure 2). 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Obesity
- What is being tested?
- behavioral telehealth and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of relapsing-remitting, secondary progressive, or primary progressive MS based on established guidelines and verified by medical chart review (b) between the ages of 18-70 (c) access to a telephone (d) English-speaking (e) ability to walk 25 feet without assistance and no severe sensory or motor impairment that would limit participation or present serious medical risks (f) no medically confirmed relapse in the past month (g) no history of dementia or severe cognitive difficulties that would limit participation (h) WHtR >.57 or BMI >29 (i) no history of bariatric surgery (j) no history of food allergies or need for a special diet preventing consumption of the recommended diet (k) no concurrent ongoing behavioral or pharmacological weight loss interventions (l) no history of insulin dependent diabetes or serious pulmonary/cardiac conditions (m) weight stability with no history of >10 pounds weight loss or gain in the 3 months prior to study participation (n) no planned or recent joint replacement surgeries (o) no serious psychiatric disorder (e.g. schizophrenia), current suicidal ideation, or current binge eating disorder as these patients may not be good candidates for behavioral weight loss programs (p) no current medical conditions where weight loss is contraindicated, as indicated by the participant's primary care physician (q) 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. -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Kansas City
Kansas City, Missouri, 64110
About this study
We will tailor a telehealth obesity intervention for obese patients with MS (figure 2). 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. Participants assigned to the control condition will also receive the active treatment 6 months following their enrollment. As such, we will have feasibility, acceptability, and outcome data for all patients who enroll and complete the intervention. During outpatient recruitment, clinicians will ask obese patients (WHtR >.57, BMI >29) if they would be willing to be contacted about a study investigating a weight loss intervention for patients with MS. Patients who express interest and respond to advertisements will be screened by telephone and via review of medical records. Patients who meet initial eligibility criteria will be invited for a baseline evaluation where they will be formally consented, complete questionnaires and behavioral tasks, and undergo a standardized physical exam. They will be monitored using actigraphy for 10 days. They will then be randomized to the group telehealth obesity intervention or TAU. At 6 months, all participants will undergo a second in-person follow-up assessment and TAU participants will begin the telehealth intervention. At 12 months, participants will undergo a third in-person assessment, providing treatment outcome data for all study participants and long-term weight maintenance data for patients initially assigned to the telehealth obesity intervention. At 18 months, participants initially assigned to the TAU control condition will undergo a 4th assessment, providing weight maintenance data for all enrolled participants.
- Conditions
- Multiple Sclerosis, Obesity
- Being tested
- behavioral telehealth, Treatment as Usual
- Medical subject headings
- Multiple Sclerosis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral telehealthBehavioural
Participants will receive 24 weekly group phone counseling sessions. Each session will last approximately 60 minutes and begin with an open-ended check-in question, followed by review of weekly self-monitoring data, question and answer time, and end with a new didactic topic of the week addressing diet, physical activity, or behavior change topics. Participants will be instructed to follow a diet that is reduced to 1200-1500 kcal/day and includes ≥ 5 fruit and vegetable (FV) servings per day, <25% kcal from fat, and 20-30 g of fiber. Physical activity will be gradually increased through a guided home-based program. Throughout the intervention, self-monitoring will be emphasized as a key behavioral weight loss strategy.
Treatment as UsualOther
Treatment as Usual
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | 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. Receives: Behavioral: behavioral telehealth; Other: Treatment as Usual |
| Group Telehealth Obesity | Experimental | 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. Receives: Behavioral: behavioral telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
percent weight change
Measured: 6 months
Secondary outcomes (4)
modified fatigue Impact scale
self-reported fatigue
Measured: 6 months
Hospital Anxiety and Depression Scale
self-reported depression
Measured: 6 months
MS Quality of Life Inventory
Self-report measure of quality of life
Measured: 6 months
6 Minute Walk
Mobility Assessment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Aug 2020
- Primary completion20 Oct 2022
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jared Bruce
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society, University of Kansas Medical Center, Children's Mercy Hospital Kansas City
- Responsible party
- Sponsor-investigator, Jared Bruce, University of Missouri, Kansas City
- Investigators
- Jared Bruce, PhD, Principal investigator, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255953
- Sponsor's protocol ID
- IRB 2016418
- Other IDs
- RG-1901-33239IRB
- Acronym
- MoDEMS
- Status last verified
- Nov 2023
- First submitted
- 3 Feb 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Telehealth Obesity Intervention for Patients With MS: Modifying Diet and Exercise in MS
- ClinicalTrials.gov ID
- NCT04255953
- Acronym / sponsor ID
- MoDEMS / IRB 2016418
- Conditions
- Multiple Sclerosis, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Jared BruceUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society, University of Kansas Medical Center, Children's Mercy Hospital Kansas City
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will tailor a telehealth obesity intervention for obese patients with MS (figure 2). 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. Participants assigned to the control condition will also receive the active treatment 6 months following their enrollment. As such, we will have feasibility, acceptability, and outcome data for all patients who enroll and complete the intervention. During outpatient recruitment, clinicians will ask obese patients (WHtR >.57, BMI >29) if they would be willing to be contacted about a study investigating a weight loss intervention for patients with MS. Patients who express interest and respond to advertisements will be screened by telephone and via review of medical records. Patients who meet initial eligibility criteria will be invited for a baseline evaluation where they will be formally consented, complete questionnaires and behavioral tasks, and undergo a standardized physical exam. They will be monitored using actigraphy for 10 days. They will then be randomized to the group telehealth obesity intervention or TAU. At 6 months, all participants will undergo a second in-person follow-up assessment and TAU participants will begin the telehealth intervention. At 12 months, participants will undergo a third in-person assessment, providing treatment outcome data for all study participants and long-term weight maintenance data for patients initially assigned to the telehealth obesity intervention. At 18 months, participants initially assigned to the TAU control condition will undergo a 4th assessment, providing weight maintenance data for all enrolled participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Behavioral: behavioral telehealth, Other: Treatment as UsualFollowing 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. |
| Group Telehealth Obesity | Experimental | Behavioral: behavioral telehealthParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a diagnosis of relapsing-remitting, secondary progressive, or primary progressive MS based on established guidelines and verified by medical chart review (b) between the ages of 18-70 (c) access to a telephone (d) English-speaking (e) ability to walk 25 feet without assistance and no severe sensory or motor impairment that would limit participation or present serious medical risks (f) no medically confirmed relapse in the past month (g) no history of dementia or severe cognitive difficulties that would limit participation (h) WHtR >.57 or BMI >29 (i) no history of bariatric surgery (j) no history of food allergies or need for a special diet preventing consumption of the recommended diet (k) no concurrent ongoing behavioral or pharmacological weight loss interventions (l) no history of insulin dependent diabetes or serious pulmonary/cardiac conditions (m) weight stability with no history of >10 pounds weight loss or gain in the 3 months prior to study participation (n) no planned or recent joint replacement surgeries (o) no serious psychiatric disorder (e.g. schizophrenia), current suicidal ideation, or current binge eating disorder as these patients may not be good candidates for behavioral weight loss programs (p) no current medical conditions where weight loss is contraindicated, as indicated by the participant's primary care physician (q) 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. -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral telehealthParticipants will receive 24 weekly group phone counseling sessions. Each session will last approximately 60 minutes and begin with an open-ended check-in question, followed by review of weekly self-monitoring data, question and answer time, and end with a new didactic topic of the week addressing diet, physical activity, or behavior change topics. Participants will be instructed to follow a diet that is reduced to 1200-1500 kcal/day and includes ≥ 5 fruit and vegetable (FV) servings per day, <25% kcal from fat, and 20-30 g of fiber. Physical activity will be gradually increased through a guided home-based program. Throughout the intervention, self-monitoring will be emphasized as a key behavioral weight loss strategy. | Behavioural | Group Telehealth Obesity, Treatment as Usual |
| Treatment as UsualTreatment as Usual | Other | Treatment as Usual |
Primary outcome
Weight Loss
Time frame: 6 months
percent weight change
4 secondary outcomes
modified fatigue Impact scale
Time frame: 6 months
Hospital Anxiety and Depression Scale
Time frame: 6 months
MS Quality of Life Inventory
Time frame: 6 months
6 Minute Walk
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Bruce, PhD principal investigator
University of Missouri, Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral telehealth and Treatment as Usual in people with Multiple Sclerosis and Obesity, run by Jared Bruce at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.