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Investigación pragmática en entornos de atención médica para mejorar la prevención y atención de la diabetes y la obesidad para nuestro programa (MAINTAIN PRIME)

10 de noviembre de 2026 actualizado por: Margaret (Molly) B. Conroy, University of Utah

Investigación pragmática en entornos de atención médica para mejorar la prevención y la atención de la diabetes y la obesidad para nuestro programa MAINTAIN PRIME (Promoción de la implementación real (mundial) a través de equipos de atención).

Many people struggle not only to lose weight through changes in diet and physical activity, but also to maintain weight loss once they have achieved it. In a previous study, our team designed and deployed a weight maintenance intervention that was delivered through the patient portal of an electronic health record (EHR) and found that patients who tracked their weight, diet, and physical activity and also received coaching had better success with maintaining recent intentional weight loss than patients who tracked but did not receive coaching. The investigators propose to repeat the intervention in a new health care system and train routine health care staff (e.g., medical assistants and nurses) to be coaches, a more sustainable model that will allow ongoing intervention delivery after the proposed study ends.

This is a pragmatic randomized clinical Trial with percent weight change at 24 months as the primary outcome. This will be a 2-arm randomized trial that compares the MAINTAIN PRIME lifestyle coaching intervention to a control tracking intervention.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Obesity is a major health problem in the United States and associated with increased risk of diabetes. While many behavioral interventions have led to successful short-term weight loss, very few programs focus on weight loss maintenance after intentional loss, and fewer still are applicable to routine health care settings. There is a great need for interventions that can assist with long-term maintenance of healthy body weight and be sustainably integrated into existing health care teams. The investigators have developed and tested an innovative weight loss maintenance intervention - Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) - delivered through the electronic health record (EHR) to help patients maintain recent intentional weight loss and successful lifestyle strategies.

The investigators have conducted and published a randomized clinical trial of MAINTAIN-pc at the University of Pittsburgh and found that participants who received EHR tracking tools and personalized coaching had significantly lower weight regain at 24 months (primary outcome) than participants who received EHR tracking tools alone. MAINTAIN-pc leveraged commonly available health information technology (HIT) tools to track participant progress and support patients and their providers in ongoing efforts to maintain weight loss. The investigators used an EHR platform (Epic) employed by many health care systems nationwide and integrated many parts of the MAINTAIN-pc protocol (e.g., patient identification, provider updates) with routine clinic workflow.

Despite the success of MAINTAIN-pc, two key questions about the practicality and sustainability of this intervention remain unanswered: (i) whether the HIT could be adapted at other sites and (ii) whether coaching could be delivered leveraging existing staff resources rather than interventionists supported by a research grant. The investigators propose a pragmatic clinical trial to test the implementation and impact of the MAINTAIN-pc protocol in routine health care settings: MAINTAIN PRIME (Promoting Real (World) IMplEmentation). MAINTAIN PRIME will be conducted in 14 primary care practices affiliated with the University of Utah and will capitalize on further advances in HIT (e.g., dashboards to track patient populations) and team-based care models to deliver the intervention with minimal support from research staff. The investigators will measure costs to inform future sustainability, and study workflow and individual, clinical, and organizational attributes to determine facilitators and barriers to successful implementation. With assistance from an External Advisory Board, the investigators will assemble an Implementation Toolkit of HIT and clinical resources to aid further dissemination.

Tipo de estudio

Intervencionista

Inscripción (Actual)

268

Fase

  • No aplica

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

    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84132
        • University of Utah Health Sciences Center

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 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Adults aged 18-75
  • BMI of ≥ 25 prior to this intended weight loss
  • Have experienced and maintained an intentional weight loss of at least 5% of body weight in the past 24 months
  • Plan to maintain a University of Utah Health relationship in one of the participating primary care practices
  • Have or be willing to get an account with the Epic MyHealth patient portal embedded in the electronic health record (EHR)

Exclusion Criteria:

  • Medical conditions that might cause unintended weight loss such as cancer or thyroid disease
  • Provider's assessment that patient is unable to safely undertake moderately intense unsupervised physical activity (the equivalent of 30 minutes of brisk walking)
  • Edematous state that interferes with bodyweight assessment (e.g., severe congestive heart failure, end-stage renal disease, or ascites)
  • Bariatric surgery in the last 2 years, or planned during the next 3 years
  • Current or planned pregnancy in the next 3 years
  • Currently breastfeeding
  • Perceived lack of basic computer or Internet skills.
  • Unable to attend the orientation/baseline visit or comply with the protocol procedures
  • Any other underlying reason or concomitant condition, which in the opinion of the principal investigator, could confound the results of the study or put the participant at undue risk.

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

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Entrenamiento de estilo de vida

Participants will receive two years patient support consisting of supportive coaching via EHR patient portal and tracking tools with EHR. Participants will also receive primary care physician (PCP) support with real time progress reports with counseling tips via EHR prior to visits, notification of weight changes greater or equal to 10 pounds, and annual PCP feedback.

Comparador activo: Seguimiento de controles

Participants will receive two years of patient support consisting of prevention updates via EHR patient portal and tracking tools within the EHR. Participants in this group will not receive primary care physician (PCP) support.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Body Weight at Baseline and 24 Months
Periodo de tiempo: Baseline and 24 months
Baseline and 24 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
BMI at Baseline and 24 Months
Periodo de tiempo: Baseline and 24 months
Baseline and 24 months
Physical Activity as Measured in Daily Steps at Baseline and 24 Months
Periodo de tiempo: Baseline and 24 months
Baseline and 24 months
Daily Minutes of Physical Activity at Baseline and 24 Months
Periodo de tiempo: Baseline and 24 months
Baseline and 24 months
Dietary Habits as Measured by Mediterranean Diet Scale Score at Baseline and 24 Months
Periodo de tiempo: Baseline and 24 months

A Mediterranean diet scale total score is a metric used to measure how closely a person's eating habits adhere with traditional, health-promoting Mediterranean diets. This 14 point scale, scored from 0-13 with higher scores indicating greater adherence.

Baseline and 24 months
Pain Intensity
Periodo de tiempo: Baseline and 24 months

Pain intensity as measured from a single Patient-Reported Outcomes Measurement Information System (PROMIS) question asking participants to rate their average pain over the past 7 days on a numeric rating scale from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity, reported as mean (SD) at baseline and 24 months.

Baseline and 24 months
Quality of Function as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire Scores at Baseline and 24 Months
Periodo de tiempo: Baseline and 24 months

The PROMIS Physical Function (PF) scale evaluates a patient's ability to perform daily activities. It is graded on a standardized T-score metric ranging from 20 to 80, where 50 represents the average U.S. general population and every 10 points represent one standard deviation. Higher scores consistently indicate better physical function.

Baseline and 24 months
Systolic Blood Pressure at Baseline and 24 Months
Periodo de tiempo: Baseline and 24 months
Baseline and 24 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

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)

8 de septiembre de 2021

Finalización primaria (Actual)

30 de junio de 2025

Finalización del estudio (Actual)

30 de junio de 2025

Fechas de registro del estudio

Enviado por primera vez

4 de junio de 2020

Primero enviado que cumplió con los criterios de control de calidad

4 de junio de 2020

Publicado por primera vez (Actual)

9 de junio de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IRB_00132802
  • 1R18DK123372-01A1 (Subvención/contrato del NIH de EE. UU.)

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. .