Increasing the Effectiveness of the Diabetes Prevention Program
20 de marzo de 2018 actualizado por: Barbel Knauper, McGill University
Increasing the Effectiveness of the Diabetes Prevention Program Through If-then Plans and Mental Practice: A Parallel Randomized Trial
The Diabetes Prevention Program (DPP) is highly effective in promoting weight loss in overweight and obese individuals (e.g., 7% average loss of body weight), and thereby reducing the risk of developing weight-related health consequences.
One-on-one DPP sessions, however, are costly and the group-delivered DPP version, the Group Lifestyle Balance program (GLB), is less effective (4% average loss of body weight).
The aim of this two-arm parallel randomized controlled trial is to increase the effectiveness of the GLB by integrating habit formation techniques, namely if-then plans and their mental practice, into the program.
The study will provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting weight loss and in reducing weight-related risk factors for chronic health problems.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Please see brief summary.
Tipo de estudio
Intervencionista
Inscripción (Actual)
172
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
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Quebec
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Montreal, Quebec, Canadá, H3A 1B1
- McGill University
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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 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- men and women
- ages of 18 and 75
- overweight or obese (BMI 28-45 kg/m2)
- sedentary (< 200 min/week of moderate or vigorous exercise)
- waist circumference of >= 88cm for women and >= 102cm for men
Exclusion Criteria:
- diabetes (hemoglobin A1c < 7.0%).
- taking the medication metformin (used for treating pre-diabetes or diabetes)
- having been pregnant in the past 6 months or planning on becoming pregnant in the next 2 years
- currently undergoing treatment for cancer
- using medication that affects body weight (e.g., loop diuretics)
- being unable to participate in regular moderate physical activity
- having severe uncontrolled hypertension (> 190/100mm Hg)
- being unable to communicate in English or French
- being diagnosed with bulimia nervosa, currently active major depression, or other severe psychiatric disease (including dementia);
- suffering from a heart attack, stroke, or heart failure within the past 6 months
- experiencing excessive weight loss (more than 10 pounds or 4.54 kilograms) in the past 3 months
- currently participating in another weight loss program
- having had bariatric surgery in the past 2 years or plans on getting it in the near future
- planning on moving away from Montreal within the next year
- having another member of one's household enrolled in the program.
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Enriched GLB
This arm aims to increase the effectiveness of the Group Lifestyle Balance (GLB) program by integrating habit formation techniques, namely if-then plans and their mental practice, into the program.
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Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.
Otros nombres:
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Comparador activo: Standard GLB
This arm is the standard Group Lifestyle Balance (GLB) program, which is the group version of the Diabetes Prevention Program developed by the NIH.
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This arm is the standard Group Lifestyle Balance program
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent body weight loss
Periodo de tiempo: 3 months after beginning of the intervention
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The primary outcome will be percent body weight loss from baseline to 3 months after the beginning of the intervention.
Weight in kg.
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3 months after beginning of the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent body weight loss
Periodo de tiempo: 12 months
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Percent body weight loss 12 months after the beginning of the intervention.
Weight in kg.
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12 months
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Percent body weight loss
Periodo de tiempo: 24 months
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Percent body weight loss 24 months after the beginning of the intervention.
Weight in kg.
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24 months
|
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Personal weight loss goal
Periodo de tiempo: 3 months
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Reaching percent body weight loss goal (7% of body weight) from baseline to 3 months after the beginning of the intervention.
Weight in kg.
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3 months
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Personal weight loss goal
Periodo de tiempo: 12 months
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Reaching percent body weight loss goal (7% of body weight) 12 months after the beginning of the intervention.
Weight in kg.
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12 months
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Personal weight loss goal
Periodo de tiempo: 24 months
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Reaching percent body weight loss goal (7% of body weight) 24 months after the beginning of the intervention.
Weight in kg.
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24 months
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Personal exercise goal
Periodo de tiempo: 3 months
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Reaching exercise goal (150 min/week) from baseline to 3 months after the beginning of the intervention.
Sum of minutes over 7 days.
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3 months
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Personal exercise goal
Periodo de tiempo: 12 months
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Reaching exercise goal (150 min/week) 12 months after the beginning of the intervention.
Sum of minutes over 7 days.
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12 months
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Personal exercise goal
Periodo de tiempo: 24 months
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Reaching exercise goal (150 min/week) 24 months after the beginning of the intervention.
Sum of minutes over 7 days.
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24 months
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Waist circumference
Periodo de tiempo: 3 months
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Risk factor for chronic health problems.
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3 months
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Waist circumference
Periodo de tiempo: 12 months
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Risk factor for chronic health problems.
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12 months
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Waist circumference
Periodo de tiempo: 24 months
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Risk factor for chronic health problems.
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24 months
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Hemoglobin A1c levels
Periodo de tiempo: 3 months
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Risk factor for chronic health problems.
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3 months
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Hemoglobin A1c levels
Periodo de tiempo: 12 months
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Risk factor for chronic health problems.
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12 months
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Hemoglobin A1c levels
Periodo de tiempo: 24 months
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Risk factor for chronic health problems.
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24 months
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Blood pressure
Periodo de tiempo: 3 months
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Risk factor for chronic health problems.
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3 months
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Blood pressure
Periodo de tiempo: 12 months
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Risk factor for chronic health problems.
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12 months
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Blood pressure
Periodo de tiempo: 24 months
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Risk factor for chronic health problems.
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24 months
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Total cholesterol/HDL ratio
Periodo de tiempo: 3 months
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Risk factor for chronic health problems.
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3 months
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Total cholesterol/HDL ratio
Periodo de tiempo: 12 months
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Risk factor for chronic health problems.
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12 months
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Total cholesterol/HDL ratio
Periodo de tiempo: 24 months
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Risk factor for chronic health problems.
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24 months
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Physical activity duration
Periodo de tiempo: 3 months
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Total minutes per week.
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3 months
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Physical activity duration
Periodo de tiempo: 12 months
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Total minutes per week.
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12 months
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Physical activity duration
Periodo de tiempo: 24 months
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Total minutes per week.
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24 months
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Number of steps taken per week
Periodo de tiempo: 3 months
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Steps taken per week, recorded using a pedometer.
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3 months
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Number of steps taken per week
Periodo de tiempo: 12 months
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Steps taken per week, recorded using a pedometer.
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12 months
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Number of steps taken per week
Periodo de tiempo: 24 months
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Steps taken per week, recorded using a pedometer.
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24 months
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Exercise stress test (EST)
Periodo de tiempo: 3 months
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3 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Self-Report Index of Habit Strength
Periodo de tiempo: 3 months
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Self-monitoring and behaviors
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3 months
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Self-Report Index of Habit Strength
Periodo de tiempo: 12 months
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Self-monitoring and behaviors
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12 months
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Self-Report Index of Habit Strength
Periodo de tiempo: 24 months
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Self-monitoring and behaviors
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24 months
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Habit formation indices of weight tracking
Periodo de tiempo: 3 months
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Frequency of weight tracking.
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3 months
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Habit formation indices of weight tracking
Periodo de tiempo: 12 months
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Frequency of weight tracking.
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12 months
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Habit formation indices of weight tracking
Periodo de tiempo: 24 months
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Frequency of weight tracking.
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24 months
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Habit formation indices of physical activity tracking
Periodo de tiempo: 3 months
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Frequency of physical activity tracking.
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3 months
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Habit formation indices of physical activity tracking
Periodo de tiempo: 12 months
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Frequency of physical activity tracking.
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12 months
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Habit formation indices of physical activity tracking
Periodo de tiempo: 24 months
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Frequency of physical activity tracking.
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24 months
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Habit formation indices of fat grams and calorie tracking
Periodo de tiempo: 3 months
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Frequency of food tracking.
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3 months
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Habit formation indices of fat grams and calorie tracking
Periodo de tiempo: 12 months
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Frequency of food tracking.
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12 months
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Habit formation indices of fat grams and calorie tracking
Periodo de tiempo: 24 months
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Frequency of food tracking.
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24 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Ilka Lowensteyn, PhD, McGill University
- Director de estudio: Lawrence Joseph, PhD, McGill University
- Director de estudio: Aleksandra Luszczynska, PhD, University of Colorado, Denver
- Director de estudio: Steven Grover, MD, McGill University
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.
Publicaciones Generales
- Knauper B, Shireen H, Carriere K, Frayn M, Ivanova E, Xu Z, Lowensteyn I, Sadikaj G, Luszczynska A, Grover S; McGill CHIP Healthy Weight Program Investigators. The effects of if-then plans on weight loss: results of the 24-month follow-up of the McGill CHIP Healthy Weight Program randomized controlled trial. Trials. 2020 Jan 7;21(1):40. doi: 10.1186/s13063-019-4014-z.
- Knauper B, Carriere K, Frayn M, Ivanova E, Xu Z, Ames-Bull A, Islam F, Lowensteyn I, Sadikaj G, Luszczynska A, Grover S; McGill CHIP Healthy Weight Program Investigators. The Effects of If-Then Plans on Weight Loss: Results of the McGill CHIP Healthy Weight Program Randomized Controlled Trial. Obesity (Silver Spring). 2018 Aug;26(8):1285-1295. doi: 10.1002/oby.22226. Epub 2018 Jun 28.
- Knauper B, Ivanova E, Xu Z, Chamandy M, Lowensteyn I, Joseph L, Luszczynska A, Grover S. Increasing the effectiveness of the Diabetes Prevention Program through if-then plans: study protocol for the randomized controlled trial of the McGill CHIP Healthy Weight Program. BMC Public Health. 2014 May 18;14:470. doi: 10.1186/1471-2458-14-470.
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)
1 de abril de 2013
Finalización primaria (Actual)
1 de diciembre de 2017
Finalización del estudio (Actual)
1 de diciembre de 2017
Fechas de registro del estudio
Enviado por primera vez
6 de diciembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
6 de diciembre de 2013
Publicado por primera vez (Estimar)
11 de diciembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de marzo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
20 de marzo de 2018
Última verificación
1 de marzo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MOP-123242
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. .
Ensayos clínicos sobre Enriched GLB
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Hangzhou GluBio Pharmaceutical Co., Ltd.ReclutamientoNo linfoma de HodgkinPorcelana
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GluBio Therapeutics Inc.ReclutamientoLeucemia mieloide aguda | Síndromes mielodisplásicosEstados Unidos
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University of PittsburghUnited States Department of DefenseTerminadoSíndrome metabólico | PrediabetesEstados Unidos
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University of PittsburghTerminadoCalidad de vida | Obesidad | Actividad física | Modificación de la dieta | Factor de riesgo cardiovascular | Limitación de movilidad | Comportamiento alimentario
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Hangzhou GluBio Pharmaceutical Co., Ltd.ReclutamientoLeucemia mieloide aguda | Síndromes mielodisplásicos | Policitemia vera | Trombocitemia esencial | Mielofibrosis | Malignidad mieloidePorcelana
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Lovoria WilliamsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Activo, no reclutando
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University of PittsburghRobert C. Atkins FoundationTerminadoDiabetesEstados Unidos
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Ohio State UniversityTerminadoPrediabetesEstados Unidos
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Baylor Research InstituteTerminadoObesidad | Pérdida de peso | Modificación de la dieta | Lesiones de la médula espinalEstados Unidos
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Baylor Research InstituteTerminadoHipertensión | Comportamiento de reducción de riesgos | Afroamericano | Dieta restringida en carbohidratosEstados Unidos