Health Coaching & Technology in a Weight Loss 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
New Hampshire
-
Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth-Hitchcock
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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;
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Amulet only
As per usual care participants will receive an eHealth (Amulet + 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
|
|
Amulet/Fitbit
As per usual care participants will receive an eHealth (Amulet/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
|
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Completion Rate: Number of Participants Completing the Intervention
Prazo: 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.
|
16 weeks
|
|
Acceptability
Prazo: 16 Weeks
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Weight
Prazo: Baseline/16 weeks
|
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)
|
Baseline/16 weeks
|
|
Change in 6 Minute Walk
Prazo: Baseline/16 weeks - pre/post change - increase = longer distance
|
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
|
Baseline/16 weeks - pre/post change - increase = longer distance
|
|
Diet Change
Prazo: 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
|
Baseline/16 weeks
|
|
Subjective Health
Prazo: Baseline/16 weeks - Change
|
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.
|
Baseline/16 weeks - Change
|
|
Readiness to Change
Prazo: 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..
The range of scores from -2 to +14.
Higher scores indicate higher readiness to change
|
16 weeks
|
|
Willingness to Pay
Prazo: 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.
|
16 weeks
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Staff Adoption
Prazo: 16 weeks
|
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).
|
16 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: John A Batsis, MD, Dartmouth-Hitchcock Medical Center
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- D17123
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em eHealth
-
University of MiamiNational Institute on Drug Abuse (NIDA)ConcluídoUso de drogas | Comportamento sexual de risco | Funcionamento familiarEstados Unidos
-
Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and DevelopmentAinda não está recrutandoSíndrome metabólica | eSaúde | Estilo de vida | Transtorno Mental Grave | Triagem somática
-
Washington University School of MedicineEpharmix, Inc.ConcluídoMedicamento de emergência | Saúde móvel | Medicina geralEstados Unidos
-
Aarhus University HospitalRecrutamentoSintomas físicos persistentesDinamarca
-
University of MiamiNational Institute of Mental Health (NIMH)Recrutamento
-
Universitat de GironaConcluídoTranstorno de Déficit de Atenção e HiperatividadeEspanha
-
University of StavangerHelse Stavanger HF; St. Olavs HospitalRecrutamentoInsuficiência cardíaca | Câncer de Cólon Retal | Doenças não comunicáveisNoruega
-
National Taiwan University HospitalRecrutamentoInfarto do miocárdioTaiwan
-
University of Ontario Institute of TechnologyDurham Region Health DepartmentDesconhecido
-
Duke UniversityConcluído