Health Coaching & Technology in a Weight Loss Center

ID: NCT03309787
Status: Recruiting
Phase: N/A
Start Date: November 29, 2017
First Submitted: October 06, 2017
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: Dartmouth-Hitchcock Medical Center
Location: United States
Conditions: Obesity, Technology, Videoconferencing, mHealth, Behavior, Health
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Behavior, Health

mHealth

Obesity

Technology

Videoconferencing

Behavioral: eHealth
Other Names
N/A

Tracking Information

First Submitted DateOctober 06, 2017
Last Update Posted DateFebruary 23, 2018
Actual Start DateNovember 29, 2017
Anticipated Completion DateJanuary 01, 2019
Actual Primary Completion DateMay 31, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Feasibility [Time Frame: 16 weeks]

    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.

  • Acceptability [Time Frame: 16 Weeks]

    Acceptability: Qualitative interviews will ensure the appropriateness of the pilot and its strengths/weaknesses.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Anthropometry [Time Frame: 16 weeks]

    Weight will be measured using a Seca 770 analyzer (in clinic) and by the Omron HBF-514 (at home remotely). Target weight loss is defined by >5% of weight. BMI is calculated by Quetelet's formula

  • Physical Function [Time Frame: 16 weeks]

    6-Minute Walk (6MWT) is a cardiovascular fitness surrogate measuring distance (normal 400-700m) related to function. A clinically important difference is 50-55m

  • Diet Change [Time Frame: 16 weeks]

    The Rapid Eating Assessment for Participants (REAPS) is a 16 item survey (score 13-39) of diet habits.

  • Exercise Change [Time Frame: 16 weeks]

    The 7-item international physical activity questionnaire (IPAQ) measures health-related activity.

  • Subjective Health [Time Frame: 16 weeks]

    The 10-question, non-proprietary Patient Reported Outcomes Measurement Information Systems General Health-10 (PROMIS) captures physical, mental and social aspects of quality of life

  • Readiness to Change [Time Frame: 16 weeks]

    The University of Rhode Island Change Assessment is a 12 item questionnaire assessing one's stages of change based on contemplation, action, maintenance and pre-contemplation.

  • Willingness to Pay [Time Frame: 16 weeks]

    Patient Perception of Value: Two questions will assess Willingness to Pay (WTP) - whether they would pay for telemedicine delivery of the intervention in lieu of in-person travel time or cost.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleHealth Coaching & Technology in a Weight Loss Center
Official TitleA Pilot Study of an eHealth-delivered Health Coaching Intervention
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.

Detailed Description

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
30
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Behavior, Health
mHealth
Obesity
Technology
Videoconferencing
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationThis 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
Intervention
Behavioral: 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

Other Names
Study Groups/Cohorts
Health Coach
As per usual care participants will receive an eHealth (mobile technology + videoconferencing) intervention over a 12 week period of time.

Study Arms
Health Coach
As per usual care participants will receive an eHealth (mobile technology + videoconferencing) intervention over a 12 week period of time.
Behavioral : 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

Arm Intervention/Treatment
Health Coach
As per usual care participants will receive an eHealth (mobile technology + videoconferencing) intervention over a 12 week period of time.
Behavioral : eHealth

Recruitment Information

Recruitment Status:Recruiting
Enrollment30
Completion DateJanuary 01, 2019
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 12 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;
GenderAll
Age18 Years to 65 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03309787
Other Study ID Numbers
D17123
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyJohn A. Batsis, MD, Dartmouth-Hitchcock Medical Center
Study Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Not Available
Investigators
Principal Investigator
John A Batsis, MD
Dartmouth-Hitchcock Medical Center