NCT03041831

Brief 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 obesity who may or may not live in a rural area.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

November 30, 2016

Last Update Submit

April 28, 2020

Conditions

Keywords

frail elderlytelemedicineobesityrural healthhealth promotion

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to one year from interview or focus group

Secondary Outcomes (1)

  • Determinants of obesity in older adults

    Up to one year from interview or focus group

Study Arms (4)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age ≥65 years;
  • Body Mass Index (BMI) ≥ 30kg/m\^2;
  • Waist circumference ≥88cm in females or ≥102cm in males

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 a nursing home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (4)

  • 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.

  • Batsis 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.

  • Batsis 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.

  • Batsis 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.

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological 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

November 30, 2016

First Posted

February 3, 2017

Study Start

August 15, 2016

Primary Completion

April 28, 2017

Study Completion

April 28, 2020

Last Updated

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations