- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04255953
Development of a Telehealth Obesity Intervention for Patients With MS: Modifying Diet and Exercise in MS (MoDEMS)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64110
- University of Missouri-Kansas City
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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. -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment as Usual
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 as Usual
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.
|
Experimental: Group Telehealth Obesity
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Loss
Time Frame: 6 months
|
percent weight change
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
modified fatigue Impact scale
Time Frame: 6 months
|
self-reported fatigue
|
6 months
|
Hospital Anxiety and Depression Scale
Time Frame: 6 months
|
self-reported depression
|
6 months
|
MS Quality of Life Inventory
Time Frame: 6 months
|
Self-report measure of quality of life
|
6 months
|
6 Minute Walk
Time Frame: 6 months
|
Mobility Assessment
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Actigraphy
Time Frame: 6 Months
|
Change in Activity pre/post treatment
|
6 Months
|
DXA
Time Frame: 6 Months
|
Body composition/Percent body fat
|
6 Months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jared Bruce, PhD, University of Missouri, Kansas City
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 2016418
- RG-1901-33239IRB (Other Grant/Funding Number: MS Society)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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