Trial Outcomes & Findings for Activity and Balanced Eating to Reduce Comorbidities and Symptoms of MS (NCT NCT03808545)
NCT ID: NCT03808545
Last Updated: 2022-11-18
Results Overview
BMI will be calculated using the formula weight/height2 (kg/m\^2). Height will be measured with participants standing against the wall. Weight will be assessed using a digital scale. BMI change will be calculated the difference between 16 week BMI and baseline BMI.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Baseline and16 weeks
Results posted on
2022-11-18
Participant Flow
Participant milestones
| Measure |
BIPAMS
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
BIPAMS
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Only completers were analyzed.
Baseline characteristics by cohort
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Only completers were analyzed.
|
0 Participants
n=7 Participants • Only completers were analyzed.
|
0 Participants
n=5 Participants • Only completers were analyzed.
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants • Only completers were analyzed.
|
4 Participants
n=7 Participants • Only completers were analyzed.
|
9 Participants
n=5 Participants • Only completers were analyzed.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • Only completers were analyzed.
|
0 Participants
n=7 Participants • Only completers were analyzed.
|
0 Participants
n=5 Participants • Only completers were analyzed.
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants • Only study completers were analyzed.
|
3 Participants
n=7 Participants • Only study completers were analyzed.
|
8 Participants
n=5 Participants • Only study completers were analyzed.
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants • Only study completers were analyzed.
|
1 Participants
n=7 Participants • Only study completers were analyzed.
|
1 Participants
n=5 Participants • Only study completers were analyzed.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Only study completers were analyzed.
|
0 Participants
n=7 Participants • Only study completers were analyzed.
|
0 Participants
n=5 Participants • Only study completers were analyzed.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • Only study completers were analyzed.
|
0 Participants
n=7 Participants • Only study completers were analyzed.
|
0 Participants
n=5 Participants • Only study completers were analyzed.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Only study completers were analyzed.
|
0 Participants
n=7 Participants • Only study completers were analyzed.
|
0 Participants
n=5 Participants • Only study completers were analyzed.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants • Only study completers were analyzed.
|
3 Participants
n=7 Participants • Only study completers were analyzed.
|
5 Participants
n=5 Participants • Only study completers were analyzed.
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants • Only study completers were analyzed.
|
1 Participants
n=7 Participants • Only study completers were analyzed.
|
4 Participants
n=5 Participants • Only study completers were analyzed.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Only study completers were analyzed.
|
0 Participants
n=7 Participants • Only study completers were analyzed.
|
0 Participants
n=5 Participants • Only study completers were analyzed.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Only study completers were analyzed.
|
0 Participants
n=7 Participants • Only study completers were analyzed.
|
0 Participants
n=5 Participants • Only study completers were analyzed.
|
PRIMARY outcome
Timeframe: Baseline and16 weeksPopulation: Only study completers were analyzed.
BMI will be calculated using the formula weight/height2 (kg/m\^2). Height will be measured with participants standing against the wall. Weight will be assessed using a digital scale. BMI change will be calculated the difference between 16 week BMI and baseline BMI.
Outcome measures
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
BMI Change
|
.60 kg/m2
Standard Deviation 1.36
|
.49 kg/m2
Standard Deviation 1.30
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksPopulation: Study completers
Waist circumference will be measured twice at the level of the umbilicus after normal expiration, with the participant standing. If the two values differ by \>1 cm, a third measurement will be taken and the results of the two or three trials averaged. Waist circumference change will be calculated as the difference between 16 week waist circumference and baseline waist circumference.
Outcome measures
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Waist Circumference Change
|
.31 cm
Standard Deviation 3.07
|
.31 cm
Standard Deviation 5.54
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksPopulation: Completers only
Participants will undergo a total body scan measuring total body composition on a Lunar iDXA with enCORE software version 13.6 (GE Healthcare, Chicago, IL). Fat mass (FM) change will be calculated the difference between 16 week FM and baseline FM.
Outcome measures
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Fat Mass Change
|
2.14 lb
Standard Deviation 6.07
|
.05 lb
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Completers only
Diastolic blood pressure (DBP) will be obtained using a sphygmomanometer. DBP will be measured twice, with a resting time of 1 minute in between each measurement. The results of the two trials will be averaged. DBP change will be calculated as the difference between 16 week DBP and baseline DBP.
Outcome measures
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Diastolic Blood Pressure Change
|
-2.20 mmHG
Standard Deviation 9.60
|
.00 mmHG
Standard Deviation 5.72
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Completers only
Systolic blood pressure (BP) will be obtained using a sphygmomanometer. SBP will be measured twice, with a resting time of 1 minute in between each measurement. The results of the two trials will be averaged. SBP change will be calculated as the difference between 16 week SBP and baseline SBP.
Outcome measures
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Systolic Blood Pressure Change
|
-6.20 mmHg
Standard Deviation 8.93
|
-4.25 mmHg
Standard Deviation 14.77
|
SECONDARY outcome
Timeframe: Baseline and16 weeksPopulation: Completers only
Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Glucose, along with other blood measures, will be assessed from this blood sample. Glucose change will be calculated as the difference between 16 week glucose and baseline glucose.
Outcome measures
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Glucose Change
|
-3.40 mg/dl
Standard Deviation 7.67
|
.00 mg/dl
Standard Deviation 14.31
|
SECONDARY outcome
Timeframe: Baseline and16 weeksPopulation: Completers only
Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Insulin, along with other blood measures, will be assessed from this blood sample. Insulin change will be calculated the difference between 16 week insulin and baseline insulin.
Outcome measures
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Insulin Change
|
-2.76 microUnits/mL
Standard Deviation 4.00
|
-2.80 microUnits/mL
Standard Deviation 11.14
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Completers only; BIPAMS group outlier lab value (n=1) was excluded from analysis
Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Triglycerides, along with other blood measures, will be assessed from this blood sample. Triglyceride change will be calculated as the difference between 16 week triglycerides and baseline triglycerides.
Outcome measures
| Measure |
BIPAMS
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Triglycerides Change
|
4.50 mg/dl
Standard Deviation 14.20
|
-12.50 mg/dl
Standard Deviation 14.53
|
SECONDARY outcome
Timeframe: Baseline and16 weeksPopulation: Completers only; BIPAMS group outlier lab value (n=1) was excluded from analysis
Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. LDL-C, along with other blood measures, will be assessed from this blood sample. LDL-C change will be calculated as the difference between 16 week LDL-C and baseline LDL-C.
Outcome measures
| Measure |
BIPAMS
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
LDL-C Change
|
-17.40 mg/dl
Standard Deviation 5.97
|
10.50 mg/dl
Standard Deviation 20.69
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Only completers were analyzed.
Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. HDL-C, along with other blood measures, will be assessed from this blood sample. HDL-C change will be calculated the difference between 16 week HDL-C and baseline HDL-C.
Outcome measures
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
HDL-C Change
|
-6.40 mg/dL
Standard Deviation 6.95
|
1.00 mg/dL
Standard Deviation 7.44
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Completers only
Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. Total cholesterol (TC), along with other blood measures, will be assessed from this blood sample. TC change will be calculated as the difference between 16 week TC and baseline TC.
Outcome measures
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Total Cholesterol Change
|
-12.00 mg/dl
Standard Deviation 19.81
|
9.00 mg/dl
Standard Deviation 29.47
|
SECONDARY outcome
Timeframe: Baseline and16 weeksPopulation: Completers only
Measured by the Fatigue Severity Scale (FSS). The total score is the sum of the 9 items. The range for scoring is 9-63, with higher scores indicating greater fatigue severity. Change in fatigue will be calculated as the difference between 16-week FSS and baseline FSS.
Outcome measures
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Change in Fatigue Severity Scale
|
1.20 score on a scale
Standard Deviation 5.63
|
4.00 score on a scale
Standard Deviation 9.24
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Completers only
Measured by the Modified Fatigue Impact Scale (MFIS). The total score is the sum of the 5 items. The range for scoring is 0-20, with higher scores indicating greater fatigue. Change in fatigue will be calculated as the difference between 16-week MFIS and baseline MFIS.
Outcome measures
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Change in Modified Fatigue Impact Scale
|
.40 score on a scale
Standard Deviation 7.57
|
-2.50 score on a scale
Standard Deviation 13.72
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Completers
Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7 item subscales. The total score is the sum of the 7 items from each subscale, and ranges from 0- 21 for the depression subscale. Higher scores in the depression subscale questions indicates greater levels of depression. Change in depression symptoms will be calculated as the difference between 16-week HADS depression subscale and baseline HADS depression subscale. Minimum score: 0; Maximum Score Depression subscale: 21
Outcome measures
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
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|---|---|---|
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Change in Depression Symptoms
|
2.40 score on a scale
Standard Deviation 2.19
|
.25 score on a scale
Standard Deviation .96
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SECONDARY outcome
Timeframe: Baseline and16 weeksPopulation: Completers only
Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7 item subscales. The total score is the sum of the 7 items from each subscale, and ranges from 0- 21 for the anxiety subscale. Higher scores in the anxiety subscale questions indicates greater levels of anxiety. Change in anxiety will be calculated as the difference between 16-week HADS anxiety subscale and baseline HADS anxiety subscale. Minimum score: 0; Maximum score anxiety subscale: 21
Outcome measures
| Measure |
BIPAMS
n=5 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=4 Participants
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Change in Anxiety
|
0.40 score on a scale
Standard Deviation 2.61
|
-2.00 score on a scale
Standard Deviation 1.41
|
Adverse Events
BIPAMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BIPAMS + Diet
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BIPAMS
n=6 participants at risk
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial. Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=5 participants at risk
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Nervous system disorders
Hospitalization
|
0.00%
0/6 • 16 weeks
All hospitalizations are included, regardless of reason or relation to study participation.
|
20.0%
1/5 • Number of events 1 • 16 weeks
All hospitalizations are included, regardless of reason or relation to study participation.
|
Other adverse events
| Measure |
BIPAMS
n=6 participants at risk
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial. Those in the BIPAMS group will continue receiving the established BIPAMS intervention for the remainder of the trial.
Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS): This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
|
BIPAMS + Diet
n=5 participants at risk
All participants will receive the standard BIPAMS intervention for the first 8 weeks of the trial.Those in the BIPAMS+Diet arm will begin receiving dietary materials in week 9.
BIPAMS + Diet: For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
|
|---|---|---|
|
Cardiac disorders
Elevated blood pressure
|
0.00%
0/6 • 16 weeks
All hospitalizations are included, regardless of reason or relation to study participation.
|
20.0%
1/5 • Number of events 1 • 16 weeks
All hospitalizations are included, regardless of reason or relation to study participation.
|
Additional Information
Brooks Wingo, Associate Professor
University of Alabama at Birmingham
Phone: 2059345982
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place