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Health Coaching & Technology in a Weight Loss Center

7 juillet 2020 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Réel)

37

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • New Hampshire
      • Lebanon, New Hampshire, États-Unis, 03756
        • Dartmouth-Hitchcock

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Amulet only
As per usual care participants will receive an eHealth (Amulet + videoconferencing) intervention over a 16 week period of time.
Comportemental: 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
Amulet/Fitbit
As per usual care participants will receive an eHealth (Amulet/Fitbit + videoconferencing) intervention over a 16 week period of time.
Comportemental: 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
Fitbit only
As per usual care participants will receive an eHealth (Fitbit + videoconferencing) intervention over a 16 week period of time.
Comportemental: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Completion Rate: Number of Participants Completing the Intervention
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Weight
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Staff Adoption
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Dartmouth-Hitchcock Medical Center

Les enquêteurs

  • Chercheur principal: John A Batsis, MD, Dartmouth-Hitchcock Medical Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 novembre 2017

Achèvement primaire (Réel)

1 octobre 2018

Achèvement de l'étude (Réel)

1 décembre 2019

Dates d'inscription aux études

Première soumission

6 octobre 2017

Première soumission répondant aux critères de contrôle qualité

10 octobre 2017

Première publication (Réel)

16 octobre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 juillet 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juillet 2020

Dernière vérification

1 juillet 2020

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • D17123

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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