Health Coaching & Technology in a Weight Loss Center
7 de julio de 2020 actualizado por: John A. Batsis, MD, Dartmouth-Hitchcock Medical Center
A Pilot Study of an eHealth-delivered Health Coaching Intervention
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
37
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth-Hitchcock
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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
Descripción
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;
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Amulet only
As per usual care participants will receive an eHealth (Amulet + videoconferencing) intervention over a 16 week period of time.
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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
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Amulet/Fitbit
As per usual care participants will receive an eHealth (Amulet/Fitbit + videoconferencing) intervention over a 16 week period of time.
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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
|
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Fitbit only
As per usual care participants will receive an eHealth (Fitbit + videoconferencing) intervention over a 16 week period of time.
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Completion Rate: Number of Participants Completing the Intervention
Periodo de tiempo: 16 weeks
|
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.
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16 weeks
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Acceptability
Periodo de tiempo: 16 Weeks
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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.
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16 Weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Weight
Periodo de tiempo: Baseline/16 weeks
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Weight will be measured using a Seca 770 analyzer (in clinic) and by the Omron HBF-514 (at home remotely).
Weight Loss (change in weight)
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Baseline/16 weeks
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Change in 6 Minute Walk
Periodo de tiempo: Baseline/16 weeks - pre/post change - increase = longer distance
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6-Minute Walk (6MWT) is a cardiovascular fitness surrogate measuring distance (normal 400-700m) related to function.
A clinically important difference or change is 50-55m
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Baseline/16 weeks - pre/post change - increase = longer distance
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Diet Change
Periodo de tiempo: Baseline/16 weeks
|
The Rapid Eating Assessment for Participants (REAPS) is a 16 item survey (score 13-39) of diet habits.
Higher scores = higher diet quality.
Positive score = better diet quality
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Baseline/16 weeks
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Subjective Health
Periodo de tiempo: Baseline/16 weeks - Change
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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.
Positive change scores = improved health.
The score ranges from 0-100, 50 is the population mean, 10 consists of 1SD, and higher scores equate better health.
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Baseline/16 weeks - Change
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Readiness to Change
Periodo de tiempo: 16 weeks
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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..
The range of scores from -2 to +14.
Higher scores indicate higher readiness to change
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16 weeks
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Willingness to Pay
Periodo de tiempo: 16 weeks
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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.
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16 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Staff Adoption
Periodo de tiempo: 16 weeks
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Staff Adoption: Haug's 12-item Measure of Evidence-Based Practice Adoption assesses stage of change, experience, attitudes, organization barriers and strategies to support evidence-based practices (1-5 point scale - strongly disagree to agree).
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16 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: John A Batsis, MD, Dartmouth-Hitchcock Medical Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
29 de noviembre de 2017
Finalización primaria (Actual)
1 de octubre de 2018
Finalización del estudio (Actual)
1 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
6 de octubre de 2017
Primero enviado que cumplió con los criterios de control de calidad
10 de octubre de 2017
Publicado por primera vez (Actual)
16 de octubre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de julio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
7 de julio de 2020
Última verificación
1 de julio de 2020
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- D17123
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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