N/A
N=54
A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS)
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02846558 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Adherence — 2; 6; 10; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Frequent Patient Interaction (Other); Timing Restriction (Behavioral); LoseIt! Smartphone Application (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence |
2; 6; 10; 12 | — |
| SECONDARY Body Mass Index (BMI) |
-0.83; -1.03; 0.04; -0.22 | — |
| SECONDARY Weight Change |
-2.15; -2.85; 0.12; -0.52 | — |
| SECONDARY Weight Change Among Adherent Participants |
-4.97; -0.22 | — |
| SECONDARY Functional Assessment in MS Score |
-3.96; 5.73; 5.42; 2.17 | — |
| SECONDARY Fatigue |
-3.38; -2.07; -0.58; 1.18 | — |
| SECONDARY Sleep Quality |
-1.33; -0.75; -1.50; -0.73 | — |
| SECONDARY Self-esteem |
0.39; -1.00; -1.00; 1.41 | — |
Summary
This is a pragmatic, single-blinded randomized trial of improving adherence to dietary interventions in patients with MS who are receiving monthly natalizumab infusions.
Eligibility Criteria
Inclusion Criteria
- Body Mass Index (BMI) ≥ 25 kg/m^2 for calorie restriction study
- BMI < 25 kg/m^2, or ≥ 25 kg/m^2 if participant was unwilling to enroll in calorie restriction study
- Smartphone with the ability to download and use the LoseIt! application (calorie restriction only)
- Smartphone with the ability to take and store photos (calorie timing only)
Exclusion Criteria
- History of diabetes requiring medication
- Currently pregnant or breastfeeding
- History of an eating disorder
- Currently taking warfarin
- History of major surgery within past 3 months
Data sourced from ClinicalTrials.gov (NCT02846558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.