MOWI Amulet Mobile Health Technology Validation

NCT ID: NCT03085589

Last Updated: 2021-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

267 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-16

Study Completion Date

2020-07-01

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.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Amulet adaptation and validation

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.

No interventions assigned to this group

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

* Severe mental or life-threatening illness
* Dementia
* Substance use
* History of bariatric surgery
* Suicidal ideation
* Unable to perform measures
* Reside in nursing home
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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John A. Batsis, MD

Associate Professor of Medicine and of The Dartmouth Institute Geisel School of Medicine at Dartmouth

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John A Batsis, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center / Dartmouth Medical School

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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https://clinicaltrials.gov/ct2/show/NCT03041831

Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative Assessment

https://clinicaltrials.gov/show/NCT03104192

Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot

https://clinicaltrials.gov/show/NCT03104205

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

Other Identifiers

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K23AG051681

Identifier Type: NIH

Identifier Source: secondary_id

View Link

D16182_1b

Identifier Type: -

Identifier Source: org_study_id

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