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El ensayo clínico NCT05176847 (mLIFE) para Sobrepeso y obesidad, Diabetes Tipo 2 está activo, no reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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The Mobile Lifestyle Intervention for Food and Exercise Study (mLIFE)

Activo, no reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT05176847 (mLIFE) es un ensayo intervencionista para Sobrepeso y obesidad, Diabetes Tipo 2. Su estado actual es: activo, no reclutando. El ensayo se inició el 1 de marzo de 2022, con el objetivo de reclutar a 240 participantes. Dirigido por la Universidad de Carolina del Sur, se espera que finalice el 30 de septiembre de 2025. Los datos se actualizaron por última vez en ClinicalTrials.gov el 4 de noviembre de 2024.
Resumen

The goal of the study is to examine long term sustained weight loss digital intervention in a diverse cohort of adults with overweight/obesity. The intervention includes social gaming (using game-like elements in nongame contexts to promote supportive social interactions and openness to positive behavioral influences) to reward behaviors, such as self-monitoring and social support.

Investigators will accomplish objectives and test hypotheses by following two specific primary aims:

  1. Determine if the intervention plus gaming produces significantly more weight loss at 12 months than the same intervention without gaming among 240 adults with overweight or obesity and ≥3 T2DM risk factors.
  2. Examine the differences in social support provision and receipt between groups at 12 months.
Descripción detallada
This is a 1-year behavioral intervention with standardized behavioral content that reinforces self-monitoring behavior delivered via twice-weekly podcasts, tips of the day, weight, physical activity and diet daily tracking. The mLife App will also encourage and facilitate social support among participants (to both groups).

Participants will be randomized to one of two groups: 1) a gamified mLIFE app (n=120) or 2) regular mLIFE app (n=120). Participants will attend a study orientation, complete all baseline measures, be randomized, and then attend a training session for their group. In addition, participants will complete assessment at 6 and 12 months.

Título oficial

Increasing Social Support for Weight Loss Through the Use of Social Gaming and Points: the Mobile Intervention for Food and Exercise (mLIFE) Study

Condiciones médicas
Sobrepeso y obesidadDiabetes Tipo 2
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este ensayo clínico:
Otros ID del ensayo
  • mLIFE
  • Pro00109784
Número del NCT
NCT05176847
Inicio del ensayo (real)
2022-03-01
Última actualización
2024-11-04
Fecha de finalización (estimada)
2025-09-30
Inscripción (prevista)
240
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Activo, no reclutando
Objetivo principal
Prevención
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Doble ciego
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalGamified mLIFE app group
Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.
Podcasts and Tips of the Day (Within APP)
Participants will receive twice weekly podcasts and daily tips of the day, with nutrition and exercise information, audio diary and goal setting.
Mlife APP (Self-regulation Features)
Diet (track by in app database), physical activity (tracked with FitBit and synced with mLIFE app), and weight (tracked with FitBit scale and synced with mL app) tracking app components. App notifications and reminders and newsfeeds.
Mlife APP (Social Support Features)
The gamified mLIFE app contains several components to help facilitate social gaming and support. This includes a newsfeed, to view the progress of other users, the ability to send others encouragement ("likes/thumbs-up") for achieving goals, user-to-user messaging system so active users of the app will be prompted to select send encouraging messages to other group members. For the experimental group, the app also includes features that facilitate healthy competition among participants through receipt of points for provision of social support and tracking health behaviors.
Comparador activostandard mLIFE app
Participants in this group will receive the same intervention as the experimental group, but some features of the App will not facilitate gaming or competition.
Podcasts and Tips of the Day (Within APP)
Participants will receive twice weekly podcasts and daily tips of the day, with nutrition and exercise information, audio diary and goal setting.
Mlife APP (Self-regulation Features)
Diet (track by in app database), physical activity (tracked with FitBit and synced with mLIFE app), and weight (tracked with FitBit scale and synced with mL app) tracking app components. App notifications and reminders and newsfeeds.
Standard Mlife APP (Social Support Features)
The standard mLIFE app has the ability to send others encouragement ("likes/thumbs-up") for achieving goals and a user-to-user messaging system so active users of the app will be prompted to select send encouraging messages to other group members.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Change in body weight
Change in body weight from baseline to 12 months as assessed digitally
12 months
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Change in Kcals consumed a day
Change in Kcal from baseline to 12 months as assessed via dietary recalls
12 months
Change in minutes a week of moderate to vigorous physical activity (MVPA)
Change in minutes a week of MVPA from baseline to 12 months as assessed via accelerometer
12 months
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
  • Must be between 18-65 years old
  • ≥3 T2DM risk factors (as defined by the American Diabetes Association)
  • Own and use a smartphone with a data plan
  • BMI must be between 25-49.9 kg/m2
  • Must be willing to reduce caloric intake and increase physical activity
  • Not currently participating in a weight loss study in a weight loss program
  • Be free of major health or psychiatric diseases, drug or alcohol dependency.
  • No current use of medications that may impact blood glucose

  • Over the age of 65 years old
  • Currently participating in a weight loss program
  • Has lost more than 10 pounds in the past 6 months
  • Diagnosed with type 2 diabetes
University of South Carolina logoUniversidad de Carolina del Sur303 ensayos clínicos activos para explorar
Parte responsable del ensayo
Brie Turner-McGrievy, Investigador principal, Associate Professor, University of South Carolina
No hay datos de contacto.
1 Sitios del ensayo en 1 países

South Carolina

University of South Carolina, Columbia, South Carolina, 29208, United States