MOWI Amulet Mobile Health Technology Validation

August 20, 2021 updated by: John A. Batsis, MD, Dartmouth-Hitchcock Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

267

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants screened and recruited primarily in local primary care setting (Department of Community and Family Medicine at Dartmouth Hitchcock Medical Center), as well as through other marketing channels such as posters and radio advertising. Community leaders and clinicians recruited by invitation from the principal investigator.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Step Count Reliability
Time Frame: All outcomes of this Aim will take approximately 3 hours
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
Time Frame: All outcomes of this Aim will take approximately 3 hours
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
Time Frame: All outcomes of this Aim will take approximately 3 hours
Assessment of sit-to-stand Amulet application validated against a conducted test
All outcomes of this Aim will take approximately 3 hours
Activity Reliability
Time Frame: All outcomes of this Aim will take approximately 3 hours
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
Time Frame: 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
All outcomes of this Aim will take approximately 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2016

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D16182_1b
  • K23AG051681 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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