ObesityNCT03085589
MOWI Amulet Mobile Health Technology Validation
An observational study of Obesity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2016to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Severe mental or life-threatening illness
- Dementia
- Substance use
- History of bariatric surgery
- Suicidal ideation
- Unable to perform measures
- Reside in nursing home
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
Official title: 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.
- Conditions
- Obesity
- Keywords
- elderly, telemedicine, obesity, rural health, health promotion
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Step Count Reliability
Assessment of step counts using Amulet application and validate this based on observation.
Measured: All outcomes of this Aim will take approximately 3 hours
Strength Reliability
Assessment of strength using Amulet-based Therabands and validated against a dynamometer
Measured: 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
Measured: All outcomes of this Aim will take approximately 3 hours
Activity Reliability
Assessment of activity application validated against observations
Measured: All outcomes of this Aim will take approximately 3 hours
Secondary outcomes (1)
Satisfaction of Amulet
Participants will be asked to respond to questions regarding usability of the Amulet mobile device measured using a Likert scale
Measured: All outcomes of this Aim will take approximately 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start16 Aug 2016
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, John A. Batsis, MD, Dartmouth-Hitchcock Medical Center
- Investigators
- John A Batsis, MD, Principal investigator, Dartmouth-Hitchcock Medical Center / Dartmouth Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085589
- Sponsor's protocol ID
- D16182_1b
- Other IDs
- K23AG051681
- Status last verified
- Aug 2021
- First submitted
- 27 Feb 2017
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development & Validation
- ClinicalTrials.gov ID
- NCT03085589
- Acronym / sponsor ID
- D16182_1b
- Conditions
- Obesity
- Keywords
- elderly, telemedicine, obesity, rural health, health promotion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 16 Aug 2016 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Severe mental or life-threatening illness
- Dementia
- Substance use
- History of bariatric surgery
- Suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Satisfaction of Amulet
Time frame: All outcomes of this Aim will take approximately 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative AssessmentLink provided by the sponsor.
- Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research PilotLink provided by the sponsor.
- Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based PilotLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Batsis, MD principal investigator
Dartmouth-Hitchcock Medical Center / Dartmouth Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step Count Reliability (time frame: All outcomes of this Aim will take approximately 3 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.