MOWI Amulet Mobile Health Technology Validation

Study Overview
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Brief Summary
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This study aims to adapt a mobile health device (Amulet) for use in older adults. It is the second in a series of four research studies whose overarching goal is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity who may or may not live in a rural area.

Official Title
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Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development & Validation

Conditions
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Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-64; and Age≥65 years Body Mass Index (BMI) ≥ 30kg/m^2 for those aged≥65 years Waist circumference ≥88cm in females or ≥102cm in male for those aged≥65 years Exclusion Criteria for those aged ≥65 years: Severe mental or life-threatening illness Dementia Substance use History of bariatric surgery Suicidal ideation Unable to perform measures Reside in nursing home

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Amulet adaptation and validation<br>The Amulet development team will develop and configure applications assessing: steps/distance; strength; activity type; gait speed; and real-time, self-monitored activity feedback. Objective measures will be validated with the Amulet from 60 participants ensuring usability and feasibility. Each participant will be asked to come into the clinic for one afternoon for about 2-3 hours. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step Count Reliability | Assessment of step counts using Amulet application and validate this based on observation. | All outcomes of this Aim will take approximately 3 hours | 
| Strength Reliability | Assessment of strength using Amulet-based Therabands and validated against a dynamometer | All outcomes of this Aim will take approximately 3 hours | 
| Sit-to-Stand Reliability | Assessment of sit-to-stand Amulet application validated against a conducted test | All outcomes of this Aim will take approximately 3 hours | 
| Activity Reliability | Assessment of activity application validated against observations | All outcomes of this Aim will take approximately 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of Amulet | Participants will be asked to respond to questions regarding usability of the Amulet mobile device measured using a Likert scale | All outcomes of this Aim will take approximately 3 hours | 

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