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NCT03085589 Clinical Trial

MOWI Amulet Mobile Health Technology Validation

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03085589
Other study ID # D16182_1b
Secondary ID K23AG051681
Status Completed
Phase
First received
Last updated
Start date August 16, 2016
Est. completion date July 1, 2020

Study information
Verified date August 2021
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 267
Est. completion date July 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (2)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Strength Reliability Assessment of strength using Amulet-based Therabands and validated against a dynamometer All outcomes of this Aim will take approximately 3 hours
Primary 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
Primary Activity Reliability Assessment of activity application validated against observations All outcomes of this Aim will take approximately 3 hours
Secondary 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
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