Trial Outcomes & Findings for A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS) (NCT NCT02846558)
NCT ID: NCT02846558
Last Updated: 2018-06-15
Results Overview
Number of participants adhering to the prescribed dietary intervention at the end of the 6-month study period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2018-06-15
Participant Flow
Participant milestones
| Measure |
Calorie Restriction - Frequent Patient Communication
MS patients receiving monthly natalizumab infusions will use the LoseIt! smartphone application to log daily food consumption. Data from the app will be collected at follow-up visits. Patients will receive initial training in using the app, and then receive weekly supportive messages encouraging them to adhere to the calorie restriction diet between 3- and 6-month followup visits. Results will be compared primarily to those collected from the Standard of Care arm.
Frequent Patient Interaction: Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
LoseIt! Smartphone Application: Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes.
|
Calorie Restriction - Communication Standard of Care
MS patients receiving monthly natalizumab infusions will use the LoseIt! smartphone application to log daily food consumption. Data from the app will be collected at follow-up visits. Besides initial training with the application and 3- and 6-month follow up exams, participants will not receive additional support or interaction from the study team.Results will be compared with those collected from the Frequent Patient Interaction arm.
LoseIt! Smartphone Application: Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes.
|
Timing Restriction
MS patients receiving monthly natalizumab infusions who are ineligible for the calorie restriction portion of the study (the Frequent Patient Activation and Standard of Care arms) will be offered the option to enroll in the second part of the study, assessing differences in outcomes between daily 16-hour fasting periods and no dietary changes. Patients in the second part of the study randomized to this arm will consume their normal daily food intake, but restrict eating to an 8-hour period during the day. Results will be compared to patients who do not make any changes to their diet, the No Change arm.
Timing Restriction: Patients continue to follow their normal diet, but limit food intake to an 8-hour period during the day.
|
No Diet Change
MS patients receiving natalizumab infusions who were ineligible for the calorie restriction portion of the study (e.g. body mass index \< 25 kg/m\^2) or did not wish to participate in calorie restriction, may elect to be part of the second portion of the study. If so, they may be randomized to this arm, in which no changes are made to amount or timing of daily food intake. Results will be compared with the experimental Timing arm
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
12
|
14
|
13
|
|
Overall Study
Baseline Study Visit
|
10
|
9
|
14
|
12
|
|
Overall Study
3 Month Study Visit
|
7
|
8
|
12
|
11
|
|
Overall Study
COMPLETED
|
7
|
8
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
2
|
2
|
Reasons for withdrawal
| Measure |
Calorie Restriction - Frequent Patient Communication
MS patients receiving monthly natalizumab infusions will use the LoseIt! smartphone application to log daily food consumption. Data from the app will be collected at follow-up visits. Patients will receive initial training in using the app, and then receive weekly supportive messages encouraging them to adhere to the calorie restriction diet between 3- and 6-month followup visits. Results will be compared primarily to those collected from the Standard of Care arm.
Frequent Patient Interaction: Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
LoseIt! Smartphone Application: Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes.
|
Calorie Restriction - Communication Standard of Care
MS patients receiving monthly natalizumab infusions will use the LoseIt! smartphone application to log daily food consumption. Data from the app will be collected at follow-up visits. Besides initial training with the application and 3- and 6-month follow up exams, participants will not receive additional support or interaction from the study team.Results will be compared with those collected from the Frequent Patient Interaction arm.
LoseIt! Smartphone Application: Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes.
|
Timing Restriction
MS patients receiving monthly natalizumab infusions who are ineligible for the calorie restriction portion of the study (the Frequent Patient Activation and Standard of Care arms) will be offered the option to enroll in the second part of the study, assessing differences in outcomes between daily 16-hour fasting periods and no dietary changes. Patients in the second part of the study randomized to this arm will consume their normal daily food intake, but restrict eating to an 8-hour period during the day. Results will be compared to patients who do not make any changes to their diet, the No Change arm.
Timing Restriction: Patients continue to follow their normal diet, but limit food intake to an 8-hour period during the day.
|
No Diet Change
MS patients receiving natalizumab infusions who were ineligible for the calorie restriction portion of the study (e.g. body mass index \< 25 kg/m\^2) or did not wish to participate in calorie restriction, may elect to be part of the second portion of the study. If so, they may be randomized to this arm, in which no changes are made to amount or timing of daily food intake. Results will be compared with the experimental Timing arm
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
Baseline Characteristics
A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS)
Baseline characteristics by cohort
| Measure |
Calorie Restriction - Frequent Patient Communication
n=10 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
|
Calorie Restriction - Communication Standard of Care
n=9 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
|
Timing Restriction
n=12 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
|
No Diet Change
n=12 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.10 years
STANDARD_DEVIATION 6.00 • n=5 Participants
|
31.18 years
STANDARD_DEVIATION 3.79 • n=7 Participants
|
39.83 years
STANDARD_DEVIATION 10.94 • n=5 Participants
|
43.42 years
STANDARD_DEVIATION 11.77 • n=4 Participants
|
41.73 years
STANDARD_DEVIATION 11.31 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-White Hispanic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
43 participants
n=21 Participants
|
|
Weight
|
92.58 kg
STANDARD_DEVIATION 17.26 • n=5 Participants
|
82.76 kg
STANDARD_DEVIATION 16.89 • n=7 Participants
|
66.25 kg
STANDARD_DEVIATION 8.12 • n=5 Participants
|
70.13 kg
STANDARD_DEVIATION 16.06 • n=4 Participants
|
76.91 kg
STANDARD_DEVIATION 17.73 • n=21 Participants
|
|
BMI
|
30.04 kg/m^2
STANDARD_DEVIATION 6.52 • n=5 Participants
|
30.22 kg/m^2
STANDARD_DEVIATION 4.78 • n=7 Participants
|
24.28 kg/m^2
STANDARD_DEVIATION 3.16 • n=5 Participants
|
25.86 kg/m^2
STANDARD_DEVIATION 6.22 • n=4 Participants
|
28.00 kg/m^2
STANDARD_DEVIATION 6.21 • n=21 Participants
|
|
Waist Circumference
|
110.22 cm
STANDARD_DEVIATION 19.31 • n=5 Participants
|
102.16 cm
STANDARD_DEVIATION 13.05 • n=7 Participants
|
87.58 cm
STANDARD_DEVIATION 11.63 • n=5 Participants
|
89.38 cm
STANDARD_DEVIATION 12.58 • n=4 Participants
|
96.4 cm
STANDARD_DEVIATION 16.68 • n=21 Participants
|
|
Hip Circumference
|
118.36 cm
STANDARD_DEVIATION 14.85 • n=5 Participants
|
109.80 cm
STANDARD_DEVIATION 7.15 • n=7 Participants
|
99.08 cm
STANDARD_DEVIATION 7.24 • n=5 Participants
|
100.26 cm
STANDARD_DEVIATION 11.01 • n=4 Participants
|
106.14 cm
STANDARD_DEVIATION 12.84 • n=21 Participants
|
|
Patient-Determined Disability Score
|
1.09 scores on a scale
STANDARD_DEVIATION 1.62 • n=5 Participants
|
1.89 scores on a scale
STANDARD_DEVIATION 1.54 • n=7 Participants
|
2.58 scores on a scale
STANDARD_DEVIATION 1.56 • n=5 Participants
|
3.00 scores on a scale
STANDARD_DEVIATION 2.14 • n=4 Participants
|
2.21 scores on a scale
STANDARD_DEVIATION 1.82 • n=21 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue-MS Score
|
21.40 scores on a scale
STANDARD_DEVIATION 9.30 • n=5 Participants
|
22.94 scores on a scale
STANDARD_DEVIATION 7.67 • n=7 Participants
|
22.50 scores on a scale
STANDARD_DEVIATION 6.49 • n=5 Participants
|
20.96 scores on a scale
STANDARD_DEVIATION 9.46 • n=4 Participants
|
21.91 scores on a scale
STANDARD_DEVIATION 8.05 • n=21 Participants
|
|
Pittsburgh Sleep Quality Index Score
|
8.50 scores on a scale
STANDARD_DEVIATION 4.56 • n=5 Participants
|
6.56 scores on a scale
STANDARD_DEVIATION 4.22 • n=7 Participants
|
7.75 scores on a scale
STANDARD_DEVIATION 5.96 • n=5 Participants
|
8.17 scores on a scale
STANDARD_DEVIATION 4.76 • n=4 Participants
|
7.79 scores on a scale
STANDARD_DEVIATION 4.74 • n=21 Participants
|
|
Quality of Life
|
174.73 scores on a scale
STANDARD_DEVIATION 38.05 • n=5 Participants
|
162.49 scores on a scale
STANDARD_DEVIATION 34.24 • n=7 Participants
|
145.81 scores on a scale
STANDARD_DEVIATION 36.48 • n=5 Participants
|
144.86 scores on a scale
STANDARD_DEVIATION 49.44 • n=4 Participants
|
156.02 scores on a scale
STANDARD_DEVIATION 40.72 • n=21 Participants
|
|
Rosenberg Self-Esteem Score
|
21.65 scores on a scale
STANDARD_DEVIATION 7.89 • n=5 Participants
|
25.11 scores on a scale
STANDARD_DEVIATION 2.42 • n=7 Participants
|
24.33 scores on a scale
STANDARD_DEVIATION 1.56 • n=5 Participants
|
24.17 scores on a scale
STANDARD_DEVIATION 2.69 • n=4 Participants
|
23.83 scores on a scale
STANDARD_DEVIATION 4.31 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsNumber of participants adhering to the prescribed dietary intervention at the end of the 6-month study period.
Outcome measures
| Measure |
Calorie Restriction - Frequent Patient Communication
n=10 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
|
Calorie Restriction - Communication Standard of Care
n=9 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
|
Timing Restriction
n=12 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
|
No Diet Change
n=12 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
|
|---|---|---|---|---|
|
Adherence
|
2 Participants
|
6 Participants
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: 5 out of the initial 43 participants dropped out of the study voluntarily
Change in body mass index from baseline to 6 months.
Outcome measures
| Measure |
Calorie Restriction - Frequent Patient Communication
n=7 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
|
Calorie Restriction - Communication Standard of Care
n=8 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
|
Timing Restriction
n=12 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
|
No Diet Change
n=11 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
|
|---|---|---|---|---|
|
Body Mass Index (BMI)
|
-0.83 kg/m^2
Standard Deviation 1.77
|
-1.03 kg/m^2
Standard Deviation 1.13
|
0.04 kg/m^2
Standard Deviation 1.09
|
-0.22 kg/m^2
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: 5 out of the initial 43 participants dropped out of the study voluntarily
Change in participant weight over the 6-month study period
Outcome measures
| Measure |
Calorie Restriction - Frequent Patient Communication
n=7 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
|
Calorie Restriction - Communication Standard of Care
n=8 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
|
Timing Restriction
n=12 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
|
No Diet Change
n=11 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
|
|---|---|---|---|---|
|
Weight Change
|
-2.15 KG
Standard Deviation 4.72
|
-2.85 KG
Standard Deviation 3.06
|
0.12 KG
Standard Deviation 3.02
|
-0.52 KG
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Discrepancy in numbers is due to non-completers. 5 out of the initial 43 participants dropped out of the study voluntarily
The change in weight over 6 months among participants were remained adherence to the calorie restriction diet versus those who admitted to non-compliance by the end of the study period.
Outcome measures
| Measure |
Calorie Restriction - Frequent Patient Communication
n=8 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
|
Calorie Restriction - Communication Standard of Care
n=8 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
|
Timing Restriction
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
|
No Diet Change
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
|
|---|---|---|---|---|
|
Weight Change Among Adherent Participants
|
-4.97 kg
Standard Deviation 4.06
|
-0.22 kg
Standard Deviation 2.38
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: 5 out of the initial 43 participants dropped out of the study voluntarily
The Functional Assessment in Multiple Sclerosis (FAMS) is an instrument that measures quality of life among people with MS. The instrument contains 44 questions scored on a 5-point Likert scale in 6 areas: mobility, symptoms, emotional wellbeing, general contentment, thanking/fatigue, and family/social wellbeing. Subscores for each area is calculated as the sum of responses in that section, and the total FAMS score is the sum of all subscores. Minimum total score is 0 and maximum total score is 176, where a higher score indicates better quality of life. Increase in the FAMS score over the study period indicates a better outcome, or improved quality of life, among participants.
Outcome measures
| Measure |
Calorie Restriction - Frequent Patient Communication
n=8 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
|
Calorie Restriction - Communication Standard of Care
n=7 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
|
Timing Restriction
n=12 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
|
No Diet Change
n=11 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
|
|---|---|---|---|---|
|
Functional Assessment in MS Score
|
-3.96 scores on a scale
Standard Deviation 28.38
|
5.73 scores on a scale
Standard Deviation 18.62
|
5.42 scores on a scale
Standard Deviation 21.71
|
2.17 scores on a scale
Standard Deviation 23.90
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Discrepancy in numbers is due to non-completers
The Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue is a question bank of 95 items validated to evaluated fatigue in a variety of chronic conditions. The PROMIS-FatigueMS is a subset of 8 questions from the question bank, which have been validated to measure fatigue in people with multiple sclerosis. Individual items are scored on a 5-point Likert scale, and the total score is the sum of individual items, with a minimum score of 8 and maximum score of 40. Lower scores indicate less fatigue, while higher scores indicate more fatigue. Reduction in score over 6 months indicates a better outcome, or improved fatigue among participants.
Outcome measures
| Measure |
Calorie Restriction - Frequent Patient Communication
n=7 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
|
Calorie Restriction - Communication Standard of Care
n=8 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
|
Timing Restriction
n=12 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
|
No Diet Change
n=11 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
|
|---|---|---|---|---|
|
Fatigue
|
-3.38 scores on a scale
Standard Deviation 3.96
|
-2.07 scores on a scale
Standard Deviation 4.60
|
-0.58 scores on a scale
Standard Deviation 5.35
|
1.18 scores on a scale
Standard Deviation 5.42
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: 5 out of the initial 43 participants dropped out of the study voluntarily
The Pittsburgh Sleep Quality Index (PSQI) is an instrument used to measure the quality and sleeping pattern of adults. It differentiates "poor" from "good" sleep quality, and the total score is calculated from the sum of seven components, each scored from 0 to 3. The minimum total score is 0 and the maximum total score is 21. A total score equal to or greater than 5 units indicates "poor" quality sleep, while a score of 0-4 indicates "good" quality sleep; lower scores indicate better sleep quality. Decrease in PSQI score indicates a better outcome, or improved sleep quality, among study participants.
Outcome measures
| Measure |
Calorie Restriction - Frequent Patient Communication
n=7 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
|
Calorie Restriction - Communication Standard of Care
n=8 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
|
Timing Restriction
n=12 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
|
No Diet Change
n=11 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
|
|---|---|---|---|---|
|
Sleep Quality
|
-1.33 scores on a scale
Standard Deviation 3.08
|
-0.75 scores on a scale
Standard Deviation 2.19
|
-1.50 scores on a scale
Standard Deviation 3.78
|
-0.73 scores on a scale
Standard Deviation 3.95
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: 5 out of the initial 43 participants dropped out of the study voluntarily
The Rosenberg Self-Esteem Scale (RSES) is a 10-item scale that measures global self-worth using a 4-point Likert scale to ask about negative and positive feelings about the self. Individual items are summed to calculate the total score. Minimum score is 0 and maximum score is 30. Scores between 15 and 25 are considered within the normal range, while scores below 15 indicates poor self-esteem. An increase in RSES score over 6 months indicates a better outcome, or improved self-esteem, among participants.
Outcome measures
| Measure |
Calorie Restriction - Frequent Patient Communication
n=7 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
|
Calorie Restriction - Communication Standard of Care
n=8 Participants
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
|
Timing Restriction
n=12 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
|
No Diet Change
n=11 Participants
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
|
|---|---|---|---|---|
|
Self-esteem
|
0.39 scores on a scale
Standard Deviation 2.06
|
-1.00 scores on a scale
Standard Deviation 1.93
|
-1.00 scores on a scale
Standard Deviation 2.70
|
1.41 scores on a scale
Standard Deviation 3.53
|
Adverse Events
Calorie Restriction - Frequent Patient Communication
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Calorie Restriction - Communication Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Timing Restriction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Diet Change
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Calorie Restriction - Frequent Patient Communication
n=10 participants at risk
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
|
Calorie Restriction - Communication Standard of Care
n=9 participants at risk
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
|
Timing Restriction
n=12 participants at risk
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
|
No Diet Change
n=12 participants at risk
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
|
|---|---|---|---|---|
|
Nervous system disorders
Migraine
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected through the duration of the 6-month intervention period for each participant. Including all participants, this data was collected from October 2016 until the end of June 2017.
|
0.00%
0/9 • Adverse event data was collected through the duration of the 6-month intervention period for each participant. Including all participants, this data was collected from October 2016 until the end of June 2017.
|
0.00%
0/12 • Adverse event data was collected through the duration of the 6-month intervention period for each participant. Including all participants, this data was collected from October 2016 until the end of June 2017.
|
0.00%
0/12 • Adverse event data was collected through the duration of the 6-month intervention period for each participant. Including all participants, this data was collected from October 2016 until the end of June 2017.
|
Additional Information
Dr. Ellen Mowry, M.D., M.C.R.
Johns Hopkins Department of Neurology
Phone: 410-502-0675
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place