ObesityNCT03041831
MOWI Qualitative Assessment
An observational study of Obesity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This qualitative study seeks to assess whether mobile health technologies are helpful for older adults. It is the first in a series of four 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2016to 28 Apr 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Older adult 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 ≥65 years;
- Body Mass Index (BMI) ≥ 30kg/m^2;
- Waist circumference ≥88cm in females or ≥102cm in males
Who cannot join
- Severe mental or life-threatening illness
- Dementia
- Substance use
- History of bariatric surgery
- Suicidal ideation
- Unable to perform measures
- Reside in a 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): Qualitative Assessment
This qualitative study seeks to assess whether mobile health technologies are helpful for older adults. It is the first in a series of four 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.
Read the detailed description
This study is designed and conducted as a series of eighteen individual semi-structured interviews and four focus group discussions. There are three participant groups: 1) older adults (age ≥ 65 years) with diagnosed obesity, 2) primary care clinicians who care for older adults, and 3) community leaders. Focus group discussions are conducted with the older adult cohort only.
- Conditions
- Obesity
- Keywords
- frail 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 |
|---|---|---|
| Older adult individual interviews | The investigators will conduct 8 semi-structured 60-minute interviews with patient participants.The goal of these interviews is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change. | |
| Clinician individual interviews | The investigators will conduct 6 semi-structured 60-minute interviews with primary care clinicians who care for older adult populations.The goal of these interviews is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change. | |
| Community leader individual interviews | The investigators will conduct 4 semi-structured 60-minute interviews with community leaders.The goal of these interviews is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change. | |
| Focus group discussions | The investigators will lead four 90-minute focus group discussions consisting of 6-8 older adult participants each. The goal of these focus groups is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technology use in older adults
The investigators will record and transcribe each interview and focus group discussion for post-hoc evaluation. The investigators will then use the transcripts to identify themes on perceptions and experience with technology use in older adults.
Measured: Up to one year from interview or focus group
Secondary outcomes (1)
Determinants of obesity in older adults
The investigators will record and transcribe each interview and focus group discussion for post-hoc evaluation. The investigators will then use the transcripts to identify themes related to the secondary outcome. Themes may include (but are not limited to) barriers and facilitators experienced by older adults when they want to lose weight or eat healthier, barriers and facilitators to joining wellness programs, and general availability of options and support.
Measured: Up to one year from interview or focus group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start15 Aug 2016
- Primary completion28 Apr 2017
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 40 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
- NCT03041831
- Sponsor's protocol ID
- D16182_1a
- Other IDs
- K23AG051681
- Status last verified
- Apr 2020
- First submitted
- 30 Nov 2016
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Batsis JA, Dokko R, Naslund JA, Zagaria AB, Kotz D, Bartels SJ, Carpenter-Song E. Opportunities to Improve a Mobile Obesity Wellness Intervention for Rural Older Adults with Obesity. J Community Health. 2020 Feb;45(1):194-200. doi: 10.1007/s10900-019-00720-y.
PubMed 31486958Batsis JA, Zagaria AB, Halter RJ, Boateng GG, Proctor P, Bartels SJ, Kotz D. Use of Amulet in behavioral change for geriatric obesity management. Digit Health. 2019 Jun 21;5:2055207619858564. doi: 10.1177/2055207619858564. eCollection 2019 Jan-Dec.
PubMed 31258927Batsis JA, Zagaria A, Kotz DF, Bartels SJ, Boateng GG, Proctor PO, Halter RJ, Carpenter-Song EA. Usability Evaluation for the Amulet Wearable Device in Rural Older Adults with Obesity. Gerontechnology. 2018 Sep;17(3):151-159. doi: 10.4017/gt.2018.17.3.003.00.
PubMed 30631251Batsis JA, Naslund JA, Zagaria AB, Kotz D, Dokko R, Bartels SJ, Carpenter-Song E. Technology for Behavioral Change in Rural Older Adults with Obesity. J Nutr Gerontol Geriatr. 2019 Apr-Jun;38(2):130-148. doi: 10.1080/21551197.2019.1600097. Epub 2019 Apr 11.
PubMed 30971189
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. 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): Qualitative Assessment
- ClinicalTrials.gov ID
- NCT03041831
- Acronym / sponsor ID
- D16182_1a
- Conditions
- Obesity
- Keywords
- frail elderly, telemedicine, obesity, rural health, health promotion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 3 Feb 2017 (estimated)
- 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 qualitative study seeks to assess whether mobile health technologies are helpful for older adults. It is the first in a series of four 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.
Detailed description
This study is designed and conducted as a series of eighteen individual semi-structured interviews and four focus group discussions. There are three participant groups: 1) older adults (age ≥ 65 years) with diagnosed obesity, 2) primary care clinicians who care for older adults, and 3) community leaders. Focus group discussions are conducted with the older adult cohort only.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Older adult individual interviews | – | –The investigators will conduct 8 semi-structured 60-minute interviews with patient participants.The goal of these interviews is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change. |
| Clinician individual interviews | – | –The investigators will conduct 6 semi-structured 60-minute interviews with primary care clinicians who care for older adult populations.The goal of these interviews is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change. |
| Community leader individual interviews | – | –The investigators will conduct 4 semi-structured 60-minute interviews with community leaders.The goal of these interviews is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change. |
| Focus group discussions | – | –The investigators will lead four 90-minute focus group discussions consisting of 6-8 older adult participants each. The goal of these focus groups is to determine the acceptability, utility, and perceived value of mobile health (mHealth) in helping older adults overcome barriers to health behavior change. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Older adult 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 ≥65 years;
- Body Mass Index (BMI) ≥ 30kg/m^2;
- Waist circumference ≥88cm in females or ≥102cm in males
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
Technology use in older adults
Time frame: Up to one year from interview or focus group
The investigators will record and transcribe each interview and focus group discussion for post-hoc evaluation. The investigators will then use the transcripts to identify themes on perceptions and experience with technology use in older adults.
1 secondary outcome
Determinants of obesity in older adults
Time frame: Up to one year from interview or focus group
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 29 Apr 2020.
- Results publication: PubMed 31486958Batsis JA, Dokko R, Naslund JA, Zagaria AB, Kotz D, Bartels SJ, Carpenter-Song E. Opportunities to Improve a Mobile Obesity Wellness Intervention for Rural Older Adults with Obesity. J Community Health. 2020 Feb;45(1):194-200. doi: 10.1007/s10900-019-00720-y.
- Results publication: PubMed 31258927Batsis JA, Zagaria AB, Halter RJ, Boateng GG, Proctor P, Bartels SJ, Kotz D. Use of Amulet in behavioral change for geriatric obesity management. Digit Health. 2019 Jun 21;5:2055207619858564. doi: 10.1177/2055207619858564. eCollection 2019 Jan-Dec.
- Results publication: PubMed 30631251Batsis JA, Zagaria A, Kotz DF, Bartels SJ, Boateng GG, Proctor PO, Halter RJ, Carpenter-Song EA. Usability Evaluation for the Amulet Wearable Device in Rural Older Adults with Obesity. Gerontechnology. 2018 Sep;17(3):151-159. doi: 10.4017/gt.2018.17.3.003.00.
- Results publication: PubMed 30971189Batsis JA, Naslund JA, Zagaria AB, Kotz D, Dokko R, Bartels SJ, Carpenter-Song E. Technology for Behavioral Change in Rural Older Adults with Obesity. J Nutr Gerontol Geriatr. 2019 Apr-Jun;38(2):130-148. doi: 10.1080/21551197.2019.1600097. Epub 2019 Apr 11.
- Mobile Health Obesity Wellness Intervention in Rural Older Adults: Amulet Technology Development \& ValidationLink 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 29 Apr 2020. 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?
Technology use in older adults (time frame: Up to one year from interview or focus group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03041831, which also lists 4 linked publications.
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 29 Apr 2020.