Health Coaching & Technology in a Weight Loss Center

NCT ID: NCT03309787

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-29
• Study Completion Date: 2019-12-01

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.

Conditions

Obesity; Technology; Videoconferencing; mHealth; Behavior, Health

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Amulet only

As per usual care participants will receive an eHealth (Amulet + videoconferencing) intervention over a 16 week period of time.

eHealth

Intervention Type: BEHAVIORAL

Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring

Amulet/Fitbit

As per usual care participants will receive an eHealth (Amulet/Fitbit + videoconferencing) intervention over a 16 week period of time.

eHealth

Intervention Type: BEHAVIORAL

Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring

Fitbit only

As per usual care participants will receive an eHealth (Fitbit + videoconferencing) intervention over a 16 week period of time.

eHealth

Intervention Type: BEHAVIORAL

Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring

Interventions

eHealth

Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring

Intervention Type: BEHAVIORAL

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

John A. Batsis, MD

Associate Professor of Medicine and The Dartmouth Institute for Health Policy & Clinical Practice

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John A Batsis, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock

Lebanon, New Hampshire, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33015640 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

D17123

Identifier Type: -

Identifier Source: org_study_id