MOWI Home-Based Pilot
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Evaluate home-based MOWI
Sponsored by

About this trial
This is an interventional health services research trial for Obesity focused on measuring frail elderly, telemedicine, obesity, rural health, health promotion, weight loss
Eligibility Criteria
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
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evaluate home-based MOWI
Arm Description
Conduct and assess the feasibility, acceptability, and potential effectiveness of home-based MOWI in improving physical function.
Outcomes
Primary Outcome Measures
Change in Grip Strength
Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.
Change in 30 Second Sit-to-Stand (STS)
STS measures lower limb strength - change represented as repetitions.
Change in Six-Minute Walk Test (6MWT)
A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m
Change in Gait Speed (Meters Per Second)
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).
Change in Late-Life Function and Disability Instrument (LLFDI)
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
Behavioral Activation (Patient Activation Measure)
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.
Subjective Health Status (PROMIS)
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.
Change in Weight in kg
Change in weight in kg
Change in Body Mass Index (BMI) in kg/m^2
Change in body mass index (BMI) in kg/m^2
Change in Waist Circumference in cm
Change in waist circumference in cm
Steps
Fitibit will assess steps
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) -
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.
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week
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.
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week
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.
Full Information
NCT ID
NCT03104205
First Posted
April 3, 2017
Last Updated
June 9, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03104205
Brief Title
MOWI Home-Based Pilot
Official Title
Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based Pilot
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
frail elderly, telemedicine, obesity, rural health, health promotion, weight loss
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single arm pilot intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evaluate home-based MOWI
Arm Type
Experimental
Arm Description
Conduct and assess the feasibility, acceptability, and potential effectiveness of home-based MOWI in improving physical function.
Intervention Type
Behavioral
Intervention Name(s)
Evaluate home-based MOWI
Intervention Description
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).
Primary Outcome Measure Information:
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
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
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
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
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
Secondary Outcome Measure Information:
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. Score ranges from 0 to 100, higher scores indicate higher activation.
Time Frame
baseline and follow-up at 26-weeks
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. A score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate better health.
Time Frame
Change between baseline and follow-up at 26-weeks
Title
Change in Weight in kg
Description
Change in weight in kg
Time Frame
Change between baseline and follow-up at 26-weeks
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
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
Title
Steps
Description
Fitibit will assess steps
Time Frame
Change between baseline and follow-up at 26-weeks
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. 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.
Time Frame
Change between baseline and follow-up at 26-weeks
Title
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week
Description
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.
Time Frame
Change between baseline and follow-up at 26-weeks
Title
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week
Description
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.
Time Frame
Change between baseline and follow-up at 26-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Batsis, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center / Dartmouth Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33435877
Citation
Batsis JA, Petersen CL, Clark MM, Cook SB, Kotz D, Gooding TL, Roderka MN, Al-Nimr RI, Pidgeon D, Haedrich A, Wright KC, Aquila C, Mackenzie TA. Feasibility and acceptability of a technology-based, rural weight management intervention in older adults with obesity. BMC Geriatr. 2021 Jan 12;21(1):44. doi: 10.1186/s12877-020-01978-x.
Results Reference
derived
Links:
URL
https://clinicaltrials.gov/show/NCT03085589
Description
Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development & Validation
URL
https://clinicaltrials.gov/ct2/show/NCT03041831
Description
Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative Assessment
URL
https://clinicaltrials.gov/show/NCT03104192
Description
Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot
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MOWI Home-Based Pilot
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