Trial Outcomes & Findings for Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults (NCT NCT04087343)
NCT ID: NCT04087343
Last Updated: 2023-02-08
Results Overview
The FFP defines frailty as having 3 or more characteristics of unintentional weight loss, fatigue, decreased physical activity, weakness, and slowness.Those who have 1 or 2 characteristics are considered pre frail, while those who have no characteristics are robust.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
baseline
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
Meals Only
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults
Baseline characteristics by cohort
| Measure |
Meals Only
n=4 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=5 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baselineThe FFP defines frailty as having 3 or more characteristics of unintentional weight loss, fatigue, decreased physical activity, weakness, and slowness.Those who have 1 or 2 characteristics are considered pre frail, while those who have no characteristics are robust.
Outcome measures
| Measure |
Meals Only
n=4 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=5 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
Frail
|
2 Participants
|
2 Participants
|
|
Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
Prefrail
|
2 Participants
|
3 Participants
|
|
Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
Robust
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after study initiationThe FFP defines frailty as having 3 or more characteristics of unintentional weight loss, fatigue, decreased physical activity, weakness, and slowness.Those who have 1 or 2 characteristics are considered pre frail, while those who have no characteristics are robust.
Outcome measures
| Measure |
Meals Only
n=4 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=5 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
Frail
|
2 Participants
|
1 Participants
|
|
Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
Prefrail
|
2 Participants
|
4 Participants
|
|
Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
Robust
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Meals Only
n=5 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=4 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Levels of Plasma Vitamin C
|
2616.67 ng/L
Standard Deviation 2334.11
|
1180.56 ng/L
Standard Deviation 73.49
|
SECONDARY outcome
Timeframe: 12 weeks from baselineOutcome measures
| Measure |
Meals Only
n=5 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=4 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Levels of Plasma Vitamin C
|
3738.89 ng/L
Standard Deviation 2714.39
|
2055.56 ng/L
Standard Deviation 304.29
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Meals Only
n=5 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=4 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Levels of Serum Folate
|
20.32 ug/L
Standard Deviation 18.67
|
10.50 ug/L
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: 12 weeks from baselineOutcome measures
| Measure |
Meals Only
n=5 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=4 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Levels of Serum Folate
|
19.56 ug/L
Standard Deviation 13.96
|
10.85 ug/L
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Meals Only
n=5 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=4 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Levels of Vitamin B12
|
839.17 ng/L
Standard Deviation 593.41
|
575.83 ng/L
Standard Deviation 139.65
|
SECONDARY outcome
Timeframe: 12 weeks from baselineOutcome measures
| Measure |
Meals Only
n=5 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=4 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Levels of Vitamin B12
|
875.42 ng/L
Standard Deviation 557.59
|
528.44 ng/L
Standard Deviation 160.04
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Meals Only
n=5 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=4 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Levels of Vitamin 25-OHD
|
120.75 ug/L
Standard Deviation 93.16
|
86.41 ug/L
Standard Deviation 33.02
|
SECONDARY outcome
Timeframe: 12 weeks from baselineOutcome measures
| Measure |
Meals Only
n=5 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=4 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Levels of Vitamin 25-OHD
|
126.72 ug/L
Standard Deviation 120.6
|
61.68 ug/L
Standard Deviation 17.92
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Meals Only
n=5 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=4 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Levels of Methylmalonic Acid (MMA)
|
533.64 pg/mL
Standard Deviation 420.41
|
406.93 pg/mL
Standard Deviation 179.8
|
SECONDARY outcome
Timeframe: 12 weeks from baselineOutcome measures
| Measure |
Meals Only
n=5 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=4 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Levels of Methylmalonic Acid (MMA)
|
554.55 pg/mL
Standard Deviation 511.10
|
388.75 pg/mL
Standard Deviation 161.44
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Meals Only
n=5 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=4 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Levels of Homocysteine (HCy)
|
19.20 pmol/uL
Standard Deviation 3.93
|
18.21 pmol/uL
Standard Deviation 7.94
|
SECONDARY outcome
Timeframe: 12 weeks from baselineOutcome measures
| Measure |
Meals Only
n=5 Participants
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=4 Participants
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Levels of Homocysteine (HCy)
|
18.83 pml/uL
Standard Deviation 6.83
|
21.24 pml/uL
Standard Deviation 5.81
|
Adverse Events
Meals Only
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Meals Plus Exercise
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Meals Only
n=4 participants at risk
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=5 participants at risk
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • 12 weeks
|
20.0%
1/5 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
Chest Pain
|
25.0%
1/4 • Number of events 1 • 12 weeks
|
0.00%
0/5 • 12 weeks
|
Other adverse events
| Measure |
Meals Only
n=4 participants at risk
Meals only: Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
Meals Plus Exercise
n=5 participants at risk
Meals plus exercise: Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall
|
25.0%
1/4 • Number of events 1 • 12 weeks
|
40.0%
2/5 • Number of events 3 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
25.0%
1/4 • Number of events 1 • 12 weeks
|
20.0%
1/5 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
Poor Appetite
|
25.0%
1/4 • Number of events 1 • 12 weeks
|
20.0%
1/5 • Number of events 1 • 12 weeks
|
|
General disorders
Tooth Pain
|
25.0%
1/4 • Number of events 1 • 12 weeks
|
0.00%
0/5 • 12 weeks
|
Additional Information
Jessica Lee, MD, MS, Assistant Professor
The University of Texas Health Science Center at Houston
Phone: 713-500-5457
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place