MOWI Amulet Mobile Health Technology Validation

NCT03085589 | Completed

• 2 other identifiers: D16182_1bK23AG051681
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

elderly; telemedicine; obesity; rural health; health promotion

Outcome Measures

Primary Outcomes (4)

• 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

• Strength Reliability

  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

  Assessment of sit-to-stand Amulet application validated against a conducted test

  All outcomes of this Aim will take approximately 3 hours

• Activity Reliability

  Assessment of activity application validated against observations

  All outcomes of this Aim will take approximately 3 hours

Secondary Outcomes (1)

• Satisfaction of Amulet

  All outcomes of this Aim will take approximately 3 hours

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Severe mental or life-threatening illness
• Dementia
• Substance use
• History of bariatric surgery
• Suicidal ideation
• Unable to perform measures
• Reside in nursing home

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Related Links

• Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative Assessment
• Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot
• Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based Pilot

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John A Batsis, MD

  Dartmouth-Hitchcock Medical Center / Dartmouth Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and of The Dartmouth Institute Geisel School of Medicine at Dartmouth

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 21, 2017
• Study Start: August 16, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)