MOWI Home-Based Pilot

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03104205
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 58
• Location: 1
• Arm: 1
• Actual Duration (Months): 34
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Evaluate home-based MOWI	N/A

Detailed Description

The national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. Conventional weight loss programs have the potential to reduce body fat, but are difficult to access for older obese adults due to transportation and mobility challenges. The overarching goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology assisted wellness intervention for older adults with obesity.

Study Timeline:

September 2018 to April 2021:

Goal: Conduct a study of improving weight and physical function in older adults with obesity at home using video-conferencing. An mHealth obesity wellness intervention (MOWI) will integrate a fitness device with a weekly individual dietician-led nutritional session, along with twice weekly physical therapist led group exercise session performed in a person's home.

Participation Duration: Three times weekly for 6 months. We shall also have participants return to the center once monthly

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A single arm pilot interventionA single arm pilot intervention
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based Pilot
• Actual Study Start Date: Oct 1, 2018
• Actual Primary Completion Date: Jul 1, 2020
• Actual Study Completion Date: Jul 31, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Evaluate home-based MOWI Conduct and assess the feasibility, acceptability, and potential effectiveness of home-based MOWI in improving physical function.

Behavioral: 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).

Outcome Measures

Primary Outcome Measures

1. Change in Grip Strength [Change between baseline and follow-up at 26-weeks]

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

2. Change in 30 Second Sit-to-Stand (STS) [Change between baseline and follow-up at 26-weeks]

   STS measures lower limb strength - change represented as repetitions.

3. Change in Six-Minute Walk Test (6MWT) [Change between baseline and follow-up at 26-weeks]

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

4. Change in Gait Speed (Meters Per Second) [Change between baseline and follow-up at 26-weeks]

   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).

5. Change in Late-Life Function and Disability Instrument (LLFDI) [Change between baseline and follow-up at 26-weeks]

   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

Secondary Outcome Measures

1. Behavioral Activation (Patient Activation Measure) [Change between baseline and follow-up at 26-weeks]

   Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors & outcomes.

2. Subjective Health Status (PROMIS) [Change between baseline and follow-up at 26-weeks]

   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.

3. Change in Weight in kg [Change between baseline and follow-up at 26-weeks]

   Change in weight in kg

4. Change in Body Mass Index (BMI) in kg/m^2 [Change between baseline and follow-up at 26-weeks]

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

5. Change in Waist Circumference in cm [Change between baseline and follow-up at 26-weeks]

   Change in waist circumference in cm

6. Steps [Change between baseline and follow-up at 26-weeks]

   Fitibit will assess steps

7. Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) [Change between baseline and follow-up at 26-weeks]

   CHAMPS is a self-reported tool in older adults that assesses activity levels and types

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age ≥65 years

• Body Mass Index (BMI) ≥ 30kg/m^2 OR Waist circumference ≥88cm in females or ≥102cm in males

• Have Wi-Fi high speed internet

• Able to obtain medical clearance from doctor

• Have less than a 5% weight loss in past 6 months

• No advanced co-morbidity

• No exercise restrictions

• Not involved in other research studies that may interfere with participation

Exclusion Criteria:

• Severe mental or life-threatening illness

• Dementia

• Substance use

• History of bariatric surgery

• Suicidal ideation

• Unable to perform measures

• Reside in nursing home

• No advanced co-morbidity

• No exercise restrictions

• Not involved in other research studies that may interfere with participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03766

Sponsors and Collaborators

• Dartmouth-Hitchcock Medical Center
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: John A Batsis, MD, Dartmouth-Hitchcock Medical Center / Dartmouth Medical School

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jul 3, 2018

More Information

Additional Information:

• Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development & Validation
• Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative Assessment
• Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot

Publications

None provided.

• Responsible Party: John A. Batsis, MD, Associate Professor of Medicine and of The Dartmouth Institute Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT03104205
• Other Study ID Numbers: D16182_3; K23AG051681
• First Posted: Apr 7, 2017
• Last Update Posted: Dec 20, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by John A. Batsis, MD, Associate Professor of Medicine and of The Dartmouth Institute Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center: frail elderly; telemedicine; obesity; rural health; health promotion; weight loss
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Evaluate Home-based MOWI
Arm/Group Description	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).
Overall Participants	53
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	53 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.9 (3.9)
Sex: Female, Male (Count of Participants)
Female	37 69.8%
Male	16 30.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	53 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	53 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	53 100%

Outcome Measures

1. Primary Outcome

Title	Change in Grip Strength
Description	Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.
Time Frame	Change between baseline and follow-up at 26-weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	MOWI Group
Arm/Group Description	Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Measure Participants	33
Mean (Standard Deviation) [kg]	1.2 (7.0)

2. Primary Outcome

Title	Change in 30 Second Sit-to-Stand (STS)
Description	STS measures lower limb strength - change represented as repetitions.
Time Frame	Change between baseline and follow-up at 26-weeks

Outcome Measure Data

Analysis Population Description

Evaluating those completing the intervention n=44

Arm/Group Title	MOWI Group
Arm/Group Description	Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Measure Participants	44
Mean (Standard Deviation) [repetitions]	3.1 (4.2)

3. Primary Outcome

Title	Change in Six-Minute Walk Test (6MWT)
Description	A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m
Time Frame	Change between baseline and follow-up at 26-weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	MOWI Group
Arm/Group Description	Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Measure Participants	33
Mean (Standard Deviation) [meters]	42.0 (77.3)

4. Primary Outcome

Title	Change in Gait Speed (Meters Per Second)
Description	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).
Time Frame	Change between baseline and follow-up at 26-weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	MOWI Group
Arm/Group Description	Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Measure Participants	33
Mean (Standard Deviation) [meters per second]	-0.34 (0.14)

5. Primary Outcome

Title	Change in Late-Life Function and Disability Instrument (LLFDI)
Description	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
Time Frame	Change between baseline and follow-up at 26-weeks

Outcome Measure Data

Analysis Population Description

Evaluating those completing the intervention n=44

Arm/Group Title	MOWI Group
Arm/Group Description	Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Measure Participants	44
Mean (Standard Deviation) [units on a scale]	3.4 (4.7)

6. Secondary Outcome

Title	Behavioral Activation (Patient Activation Measure)
Description	Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors & outcomes.
Time Frame	Change between baseline and follow-up at 26-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Subjective Health Status (PROMIS)
Description	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.
Time Frame	Change between baseline and follow-up at 26-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Change in Weight in kg
Description	Change in weight in kg
Time Frame	Change between baseline and follow-up at 26-weeks

Outcome Measure Data

Analysis Population Description

Evaluating those completing the intervention n=44

Arm/Group Title	MOWI Group
Arm/Group Description	Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Measure Participants	44
Mean (Standard Deviation) [kg]	-4.6 (3.5)

9. Secondary Outcome

Title	Change in Body Mass Index (BMI) in kg/m^2
Description	Change in body mass index (BMI) in kg/m^2
Time Frame	Change between baseline and follow-up at 26-weeks

Outcome Measure Data

Analysis Population Description

Evaluating those completing the intervention n=44

Arm/Group Title	MOWI Group
Arm/Group Description	Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Measure Participants	44
Mean (Standard Deviation) [kg/m^2]	-1.8 (1.4)

10. Secondary Outcome

Title	Change in Waist Circumference in cm
Description	Change in waist circumference in cm
Time Frame	Change between baseline and follow-up at 26-weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	MOWI Group
Arm/Group Description	Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Measure Participants	33
Mean (Standard Deviation) [cm]	-2.6 (5.4)

11. Secondary Outcome

Title	Steps
Description	Fitibit will assess steps
Time Frame	Change between baseline and follow-up at 26-weeks

Outcome Measure Data

Analysis Population Description

Evaluating those completing the intervention n=44

Arm/Group Title	MOWI Group
Arm/Group Description	Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
Measure Participants	44
Mean (Standard Deviation) [steps]	4078 (3819)

12. Secondary Outcome

Title	Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS)
Description	CHAMPS is a self-reported tool in older adults that assesses activity levels and types
Time Frame	Change between baseline and follow-up at 26-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	6 months - duration of the intervention
Arm/Group Title	MOWI Group
Arm/Group Description	Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria
All Cause Mortality
	MOWI Group
	Affected / at Risk (%)	# Events
Total	0/53 (0%)
Serious Adverse Events
	MOWI Group
	Affected / at Risk (%)	# Events
Total	1/53 (1.9%)
Cardiac disorders
Atrial Fibrillation	1/53 (1.9%)	1
Other (Not Including Serious) Adverse Events
	MOWI Group
	Affected / at Risk (%)	# Events
Total	14/53 (26.4%)
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain	14/53 (26.4%)	14

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.