Health Coaching & Technology in a Weight Loss Center

NCT03309787 | Completed Results DMC

• 1 other identifier: D17123
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Completion Rate: Number of Participants Completing the Intervention

  Completion/ Feasibility: The following rates will be computed: screened for inclusion; eligibility; enrollment; completion; assessment. We will assess entry criteria (reasons for dropout/non-adherence) and time to collect data. Enrollment success will be defined as 30 patients. Adequate retention is defined as a dropout rate of \<20%. Completion of \>80% of post-study measures will be defined as adequate. Attending \>80% of sessions will be considered acceptable. Staff will track equipment, software or technical issues (malfunctions, data loss, hardware) in a journal.

  16 weeks

• Acceptability

  Acceptability: Qualitative interviews will ensure the appropriateness of the pilot and its strengths/weaknesses. Participants will answer questions on a scale from 0-5, where 5 = high acceptability of the program.

  16 Weeks

Secondary Outcomes (6)

• Change in Weight

  Baseline/16 weeks

• Change in 6 Minute Walk

  Baseline/16 weeks - pre/post change - increase = longer distance

• Diet Change

  Baseline/16 weeks

• Subjective Health

  Baseline/16 weeks - Change

• Readiness to Change

  16 weeks

Other Outcomes (1)

• Staff Adoption

  16 weeks

Study Arms (3)

Amulet only

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

Behavioral: eHealth

Amulet/Fitbit

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

Behavioral: eHealth

Fitbit only

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

Behavioral: eHealth

Interventions

eHealth 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 only; Amulet/Fitbit; Fitbit only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• 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.

  PMID: 33015640 DERIVED

MeSH Terms

Conditions

Obesity; Health Behavior

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: John A. Batsis, MD
• Organization: Dartmouth-Hitchcock

john.batsis@gmail.com

603-650-5000

Study Officials

• John A Batsis, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and The Dartmouth Institute for Health Policy & Clinical Practice

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 16, 2017
• Study Start: November 29, 2017
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2019
• Last Updated: July 8, 2020
• Results First Posted: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)