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MOWI Amulet Mobile Health Technology Validation

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ClinicalTrials.gov Identifier: NCT03085589
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
John A. Batsis, MD, 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.

Condition or disease
Obesity

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Study Type : Observational
Estimated Enrollment : 14 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development & Validation
Actual Study Start Date : August 16, 2016
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : July 1, 2021

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.



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. Activity Reliability [ Time Frame: All outcomes of this Aim will take approximately 3 hours ]
    Assessment of activity application validated against observations


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085589


Contacts
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Contact: Tyler L Gooding, BA 603-650-5000 mowi@hitchcock.org
Contact: John A Batsis, MD 603-650-5000 mowi@hitchcock.org

Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Tyler L Gooding, BA       mowi@hitchcock.org   
Contact: John A Batsis, MD       mowi@hitchcock.org   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute on Aging (NIA)
Investigators
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Principal Investigator: John A Batsis, MD Dartmouth-Hitchcock Medical Center / Dartmouth Medical School
  Study Documents (Full-Text)

Documents provided by John A. Batsis, MD, Dartmouth-Hitchcock Medical Center:

Additional Information:
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Responsible Party: John A. Batsis, MD, Associate Professor of Medicine and of The Dartmouth Institute Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03085589     History of Changes
Other Study ID Numbers: D16182_1b
K23AG051681 ( U.S. NIH Grant/Contract )
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John A. Batsis, MD, Dartmouth-Hitchcock Medical Center:
elderly
telemedicine
obesity
rural health
health promotion
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms