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Development of a Telehealth Obesity Intervention for Patients With MS: Modifying Diet and Exercise in MS

Development of a Telehealth Obesity Intervention for Patients With MS: Modifying Diet and Exercise in MS

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04255953
Acronym
MoDEMS
Enrollment
70
Registered
2020-02-05
Start date
2020-08-01
Completion date
2023-09-20
Last updated
2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Obesity

Brief 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. 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.

Interventions

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.

OTHERTreatment as Usual

Treatment as Usual

Sponsors

National Multiple Sclerosis Society
CollaboratorOTHER
University of Kansas Medical Center
CollaboratorOTHER
Children's Mercy Hospital Kansas City
CollaboratorOTHER
Jared Bruce
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

(a) 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. -

Design outcomes

Primary

MeasureTime frameDescription
Weight Loss6 monthspercent weight change

Secondary

MeasureTime frameDescription
modified fatigue Impact scale6 monthsself-reported fatigue
Hospital Anxiety and Depression Scale6 monthsself-reported depression
MS Quality of Life Inventory6 monthsSelf-report measure of quality of life
6 Minute Walk6 monthsMobility Assessment

Other

MeasureTime frameDescription
Actigraphy6 MonthsChange in Activity pre/post treatment
DXA6 MonthsBody composition/Percent body fat

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026