MOWI Home-Based Pilot

Study Overview
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Brief Summary
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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
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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

Official Title
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Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based Pilot

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Evaluate home-based MOWI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: A single arm pilot intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluate home-based MOWI<br>Conduct and assess the feasibility, acceptability, and potential effectiveness of home-based MOWI in improving physical function. | Behavioral: Evaluate home-based MOWI<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Grip Strength | Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change. | Change between baseline and follow-up at 26-weeks | 
| Change in 30 Second Sit-to-Stand (STS) | STS measures lower limb strength - change represented as repetitions. | Change between baseline and follow-up at 26-weeks | 
| 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 between baseline and follow-up at 26-weeks | 
| 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 between baseline and follow-up at 26-weeks | 
| 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 | Change between baseline and follow-up at 26-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and follow-up at 26-weeks | 
| 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 between baseline and follow-up at 26-weeks | 
| Change in Weight in kg | Change in weight in kg | Change between baseline and follow-up at 26-weeks | 
| Change in Body Mass Index (BMI) in kg/m^2 | Change in body mass index (BMI) in kg/m^2 | Change between baseline and follow-up at 26-weeks | 
| Change in Waist Circumference in cm | Change in waist circumference in cm | Change between baseline and follow-up at 26-weeks | 
| Steps | Fitibit will assess steps | Change between baseline and follow-up at 26-weeks | 
| 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. | Change between baseline and follow-up at 26-weeks | 
| 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. | Change between baseline and follow-up at 26-weeks | 
| 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. | Change between baseline and follow-up at 26-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frail elderly, telemedicine, obesity, rural health, health promotion, weight loss