MOWI Amulet Mobile Health Technology Validation

Completed

• Conditions: Obesity

• Registration Number: NCT03085589
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-16
• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-21
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Satisfaction of Amulet	All outcomes of this Aim will take approximately 3 hours	Participants will be asked to respond to questions regarding usability of the Amulet mobile device measured using a Likert scale

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States