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Trial record 26 of 149 for:    Recruiting, Not yet recruiting, Available Studies | NIA

MOWI Amulet Mobile Health Technology Validation

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Dartmouth-Hitchcock Medical Center
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT03085589
First received: February 27, 2017
Last updated: May 22, 2017
Last verified: May 2017
  Purpose
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
Obesity

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development & Validation

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • 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.

  • 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

  • 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

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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: August 2016
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03085589

Contacts
Contact: Alexandra B Zagaria, BA 603-650-5000 mowi@hitchcock.org
Contact: John A Batsis, MD 603-650-5000 mowi@hitchcock.org

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Alexandra B Zagaria, 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
Principal Investigator: John A Batsis, MD Dartmouth-Hitchcock Medical Center / Dartmouth Medical School
  More Information

Additional Information:
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03085589     History of Changes
Other Study ID Numbers: D16182_1b
1K23AG051681-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: February 27, 2017
Last Updated: May 22, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Dartmouth-Hitchcock Medical Center:
elderly
telemedicine
obesity
rural health
health promotion

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 23, 2017