Trial Outcomes & Findings for MOWI Home-Based Pilot (NCT NCT03104205)

NCT ID: NCT03104205

Last Updated: 2023-06-12

Results Overview

Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: Change between baseline and follow-up at 26-weeks
• Results posted on: 2023-06-12

Participant Flow

Participant milestones

Measure	MOWI Group Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Overall Study STARTED	53
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MOWI Home-Based Pilot

Baseline characteristics by cohort

Measure	Evaluate Home-based MOWI n=53 Participants Conduct and assess the feasibility, acceptability, and potential effectiveness of home-based MOWI in improving physical function. Evaluate home-based MOWI: MOWI will be delivered via video-conferencing in the subject's home in a 3x per week, 26-week program from the coordinating center. It will include an individual dietician-led weekly nutrition session; 2x/week physical therapist-led group exercise session; and remote fitness device monitoring. We plan 5 cohorts of 8 subjects (n=40). In-person Research Assistant-led assessments will occur at 0, 8, 16 and 26 weeks. Recruitment, screening, selection criteria, and usability parallel Aim 2 (NCT03104192).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	53 Participants n=5 Participants
Age, Continuous	72.9 years STANDARD_DEVIATION 3.9 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants

PRIMARY outcome

Timeframe: Change between baseline and follow-up at 26-weeks

Population: Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions.

Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.

Outcome measures

Measure	MOWI Group n=33 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Change in Grip Strength	1.2 kg Standard Deviation 7.0

PRIMARY outcome

Timeframe: Change between baseline and follow-up at 26-weeks

Population: Evaluating those completing the intervention n=44

STS measures lower limb strength - change represented as repetitions.

Outcome measures

Measure	MOWI Group n=44 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Change in 30 Second Sit-to-Stand (STS)	3.1 repetitions Standard Deviation 4.2

PRIMARY outcome

Timeframe: Change between baseline and follow-up at 26-weeks

Population: Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions.

A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m

Outcome measures

Measure	MOWI Group n=33 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Change in Six-Minute Walk Test (6MWT)	42.0 meters Standard Deviation 77.3

PRIMARY outcome

Timeframe: Change between baseline and follow-up at 26-weeks

Population: Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions.

Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (a significant change is considered 0.1 meters per second).

Outcome measures

Measure	MOWI Group n=33 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Change in Gait Speed (Meters Per Second)	-0.34 meters per second Standard Deviation 0.14

PRIMARY outcome

Timeframe: Change between baseline and follow-up at 26-weeks

Population: Evaluating those completing the intervention n=44

LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. For this instrument we use only the 32-item function and scores are scaled. Minimum 0, Maximum 100. Higher scores indicate higher levels of function

Outcome measures

Measure	MOWI Group n=44 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Change in Late-Life Function and Disability Instrument (LLFDI)	3.4 units on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: baseline and follow-up at 26-weeks

Population: Subjective data is analyzed baseline and follow-up of participants n=53

Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors & outcomes. Score ranges from 0 to 100, higher scores indicate higher activation.

Outcome measures

Measure	MOWI Group n=53 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Behavioral Activation (Patient Activation Measure) Baseline	69.4 score on a scale Standard Deviation 12.1
Behavioral Activation (Patient Activation Measure) 26-weeks	77.0 score on a scale Standard Deviation 14.6

SECONDARY outcome

Timeframe: Change between baseline and follow-up at 26-weeks

Population: these are completers

Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. A score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate better health.

Outcome measures

Measure	MOWI Group n=44 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Subjective Health Status (PROMIS) Physical Function	3.63 Change in the T score on a scale Standard Deviation 4.89
Subjective Health Status (PROMIS) Mental Function	2.65 Change in the T score on a scale Standard Deviation 5.70

SECONDARY outcome

Timeframe: Change between baseline and follow-up at 26-weeks

Population: Evaluating those completing the intervention n=44

Change in weight in kg

Outcome measures

Measure	MOWI Group n=44 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Change in Weight in kg	-4.6 kg Standard Deviation 3.5

SECONDARY outcome

Timeframe: Change between baseline and follow-up at 26-weeks

Population: Evaluating those completing the intervention n=44

Change in body mass index (BMI) in kg/m^2

Outcome measures

Measure	MOWI Group n=44 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Change in Body Mass Index (BMI) in kg/m^2	-1.8 kg/m^2 Standard Deviation 1.4

SECONDARY outcome

Timeframe: Change between baseline and follow-up at 26-weeks

Population: Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions.

Change in waist circumference in cm

Outcome measures

Measure	MOWI Group n=33 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Change in Waist Circumference in cm	-2.6 cm Standard Deviation 5.4

SECONDARY outcome

Timeframe: Change between baseline and follow-up at 26-weeks

Population: Evaluating those completing the intervention n=44

Fitibit will assess steps

Outcome measures

Measure	MOWI Group n=44 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Steps	4078 steps Standard Deviation 3819

SECONDARY outcome

Timeframe: Change between baseline and follow-up at 26-weeks

Population: These are the completers of the intervention

CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week.

Outcome measures

Measure	MOWI Group n=44 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - low intensity caloric expenditure per week (ckal/week)	312.69 Kcal/week Standard Deviation 1323.67
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - moderate intensity caloric expenditure (Kcal/wk)	5.05 Kcal/week Standard Deviation 10.54

SECONDARY outcome

Timeframe: Change between baseline and follow-up at 26-weeks

Population: These are the completers of the intervention

CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week.

Outcome measures

Measure	MOWI Group n=44 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week Not Exercising Frequency (frequency per week)	-2.93 exercise frequency per week Standard Deviation 15.06
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week Low intensity frequency (frequency per week)	2.36 exercise frequency per week Standard Deviation 7.90
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week moderate intensity frequency (frequency per week)	2.68 exercise frequency per week Standard Deviation 5.30

SECONDARY outcome

Timeframe: Change between baseline and follow-up at 26-weeks

Population: These are the completers of the intervention

CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week.

Outcome measures

Measure	MOWI Group n=44 Participants Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week Not exercise duration (hours per week)	-0.23 exercise hours per week Standard Deviation 11.16
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week low intensity duration (hours/week)	1.64 exercise hours per week Standard Deviation 5.35
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week moderate intensity duration (hours per week)	1.65 exercise hours per week Standard Deviation 4.45

Adverse Events

MOWI Group

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	MOWI Group n=53 participants at risk Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Cardiac disorders Atrial Fibrillation	1.9% 1/53 • Number of events 1 • 6 months - duration of the intervention

Other adverse events

Measure	MOWI Group n=53 participants at risk Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	26.4% 14/53 • Number of events 14 • 6 months - duration of the intervention

Additional Information

John A. Batsis

Dartmouth-Hitchcock

Phone: 6036505000

Email: john.a.batsis@hitchcock.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place