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

Obesity Clinical Trial

— MoDEMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255953
• Other study ID #: IRB 2016418
• Secondary ID: RG-1901-33239IRB
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: September 20, 2023

Study information

• Verified date: November 2023
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 20, 2023
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Multiple Sclerosis
• Obesity

Intervention

Behavioral:
• behavioral telehealth
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.

Other:
• Treatment as Usual
Treatment as Usual

Locations

Country	Name	City	State
United States	University of Missouri-Kansas City	Kansas City	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Jared Bruce	Children's Mercy Hospital Kansas City, National Multiple Sclerosis Society, University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Actigraphy	Change in Activity pre/post treatment	6 Months
Other	DXA	Body composition/Percent body fat	6 Months
Primary	Weight Loss	percent weight change	6 months
Secondary	modified fatigue Impact scale	self-reported fatigue	6 months
Secondary	Hospital Anxiety and Depression Scale	self-reported depression	6 months
Secondary	MS Quality of Life Inventory	Self-report measure of quality of life	6 months
Secondary	6 Minute Walk	Mobility Assessment	6 months