Clinical trial NCT03309787: Health Coaching & Technology in a Weight Loss Center
Official title: A Pilot Study of an eHealth-delivered Health Coaching Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Technology
Videoconferencing
mHealth
Behavior, Health
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit 30 older motivated adults with obesity (aged 18-65 years). This study pilot will be based at the Dartmouth-Hitchcock (D-H) Weight and Wellness Center (DH-WWC) in Lebanon, NH. No randomization will be performed. Health coaches will deliver the intervention to participants

Brief summary: The national epidemic of obesity is associated with considerable morbidity, disability and early mortality.

Conventional weight loss programs beyond a primary care setting have the potential to reduce weight, but are difficult to access for adults with obesity in rural areas due to lack of transportation and access to specialty care. Routine intensive behavioral therapy, while effective, is often not supplemented with adjuncts that could be helpful in engaging participants in behavioral change. The overarching goal of this SYNERGY pilot project is to overcome barriers rural adults face by using video-conferencing to deliver specialty obesity care that otherwise is inaccessible to most adults faced with this disease. It also intends to use emerging mobile health (mHealth) technology which has shown considerable promise in providing motivational feedback. This proposal highlights T3/T4 translation bridging technologists, allied health staff, and clinicians in the development and implementation of new therapeutic modalities. The study aims to evaluate a telehealth-based health coaching program that is embedded in the Dartmouth-Hitchcock Weight and Wellness Center that integrates novel remote monitoring technology in effecting behavioral change using Amulet, a Dartmouth Computer Science developed mHealth device over a 16-week period. First, the feasibility and accessibility of an eHealth-delivered health coaching obesity intervention using remote monitoring and video-conferencing (Aim 1) will be evaluated. The potential effectiveness of achieving the primary outcome of 5% weight loss, with secondary outcomes of improved physical function and self reported health (Aim 2) will be ascertained. The intervention's impact on implementation outcomes of workflow, adoption, and organizational change that could affect further scalability and generalizability in other high-risk population groups (Aim 3) will be assessed. These preliminary findings will be used in a future competitive application for an extramural R01 designed to assess the effectiveness of our intervention in achieving weight loss in rural obese adults. If successful, this application has the potential to redesign care using applied methods of telehealth translated to community-based, rural populations to facilitate behavioral change. The project also meets criteria of the NIH Strategic Plan for Obesity and the Institute of Medicine's need for Telehealth research.


Eligibility criteria: Inclusion Criteria:

* English speaking;
* Community-dwelling;
* Age 18-65 years;
* Obesity based on: BMI ≥30kg/m2 54;
* Participating in the DH-WWC health coach program;
* Access to home, high-speed internet with Wi-Fi;
* Medical clearance from their primary care provider;
* Provide voluntary, written consent;
* Require an EHR patient portal account and credentials ; -----If subjects do not have an account, one will be created for the purposes of this study

Exclusion Criteria:

* Unwilling to participate in the 16 week pilot or complete study measures;
* Individuals unwilling/unable to provide consent;
* A medical record diagnosis of dementia as intensive behavioral therapy and health coaching require the ability to complete questionnaires and change behavior, all of which may be challenging in individuals with cognitive impairment;
* Cognitive impairment measured by the 6-item Callahan screen, a brief and reliable six-item screening questionnaire with acceptable sensitivity (88.7%) and specificity (88.0%) in identifying individuals with cognitive impairment. Its diagnostic properties are comparable to the full Folstein Mini-Mental Status Examination in those scoring ≥3. This questionnaire can be administered by telephone or face-to-face interview and is being as an adjunct to medical record documentation of cognitive impairment;
* Life-threatening illness including those receiving palliative care or hospice services;
* Nursing facility or hospital admission in the past six months;
* Psychiatric diagnosis that would interfere with study participation and require significant modification to meet their needs such as major depressive disorder, substance abuse, suicidal ideation or severe mental illness (schizophrenia, bipolar disorder);
* History of bariatric surgery;
* American College of Sports Medicine contraindications to exercise57 including: a resting heart rate of \>120bpm; Blood pressure \>180/100mmHg; unstable angina;

Primary outcomes:
measure: Completion Rate: Number of Participants Completing the Intervention
timeFrame: 16 weeks
measure: Acceptability
timeFrame: 16 Weeks
Secondary outcomes:
measure: Change in Weight
timeFrame: Baseline/16 weeks
measure: Change in 6 Minute Walk
timeFrame: Baseline/16 weeks - pre/post change - increase = longer distance
measure: Diet Change
timeFrame: Baseline/16 weeks
measure: Subjective Health
timeFrame: Baseline/16 weeks - Change
measure: Readiness to Change
timeFrame: 16 weeks
measure: Willingness to Pay
timeFrame: 16 weeks
Other outcomes:
measure: Staff Adoption
timeFrame: 16 weeks
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: John A Batsis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Batsis JA, McClure AC, Weintraub AB, Sette D, Rotenberg S, Stevens CJ, Gilbert-Diamond D, Kotz DF, Bartels SJ, Cook SB, Rothstein RI. Barriers and facilitators in implementing a pilot, pragmatic, telemedicine-delivered healthy lifestyle program for obesity management in a rural, academic obesity clinic. Implement Sci Commun. 2020 Sep 30;1:83. doi: 10.1186/s43058-020-00075-9. eCollection 2020.