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Completed

NCT Number: NCT03085589

MOWI Amulet Mobile Health Technology 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 21, 2017
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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