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- Ensayo clínico NCT01051713
ENGAGED: E-Networks Guiding Adherence to Goals for Exercise and Diet (ENGAGED)
10 de noviembre de 2016 actualizado por: Bonnie Spring, Northwestern University
The ENGAGED study is a 12-month randomized controlled trial investigating different strategies to improve weight loss in overweight individuals.
All participants will receive an effective weight loss treatment: either self-guided or group formats.
All treatment will be provided in the Department of Preventive Medicine at Northwestern University.
Participants who receive the self-guided weight loss treatment will be provided with a weight loss manual that contains proven behavioral weight loss strategies.
Those participants who receive the group treatment will take part in 8 weekly, 90 minute group sessions in our clinic at 680 N. Lakeshore Dr., Chicago, IL 60048.
Some participants will also be assigned an individual coach, who will communicate with them regularly via phone, email, and/or text message for the duration of the study.
All participants must be willing and able to record food and beverage intake (either on a smartphone or on paper) and be willing to wear a small and unobtrusive physical activity measurement device for the first six-months of the study.
Additionally, all participants will be asked to attend 3 follow-up assessment visits at our clinic at months 3, 6 and 12 after the study begins.
Participants will be compensated for completing each of the 3 follow-up assessments.
All participants will be part of a team weight loss competition at 3 and 6 months with financial incentive to be split evenly among the winning team.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The Diabetes Prevention Program (DPP) intensive lifestyle intervention is the gold standard weight loss treatment for adults with cardiometabolic risk factors.
Despite its efficacy, the DPP has not been widely adopted, because its 16 individual, face-to-face sessions with a specialist are considered too burdensome and expensive to be a sustainable program.
Attempts to reduce cost by decreasing session number have yielded greatly diminished weight loss.
Behavioral adherence to diet and activity goals declines and weight regain routinely begins once frequent face-to-face meetings cease.
The still unmet challenge of DPP implementation is how to reduce treatment intensity without excising the regular social support, accountability, and feedback that are essential to maintain adherence.
We hypothesize that it is feasible to implement DPP Intensive Lifestyle Treatment as effectively but twice as efficiently by using hand held technology to preserve feedback, accountability, and regular social support.
The smartphone-based technology system to be tested is guided by Carver and Scheier's control systems theory of self-regulation.
Initial formative research will upgrade the smartphone with engaging features that motivate participants to use the device to self-monitor and interact with a coach and peer support group.
Use of the finalized tool will be compared to usual recording on paper records in a preliminary 3-group randomized controlled trial (RCT) involving 96 obese adults.
By enabling peer support, accountability, and feedback on diet, physical activity, and weight loss goals continuously through the 6-month intervention period, the ENGAGED system is expected to enhance (1) behavioral adherence [operationalized by (a) self-monitoring of diet and activity and (b) attainment of diet and activity goals], and (2) weight loss.
An enabling technology that integrates specialist and peer support resources to improve treatment adherence could help to curtail the obesity epidemic by increasing the efficiency, feasibility, and reach of effective DPP lifestyle intervention.
Tipo de estudio
Intervencionista
Inscripción (Actual)
96
Fase
- Fase 2
- Fase 1
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
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
-
-
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 60 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- BMI between 30-40
- weight stable (not gained/lost more than 25 lbs in the past 6 months)
- not enrolled in any formal weight-loss program
- interested in losing weight
- willing and able to record dietary intake and weight for 6 months and wear an accelerometer
- willing to attend 8 weekly groups and 2 follow up assessments at the Northwestern Chicago campus
- expect to reside in the Chicago land area for the next 12 months
Exclusion Criteria:
- any unstable medical conditions (i.e. uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, a cerebrovascular accident within the past 6 months)
- history of insulin-dependent diabetes
- Crohn's disease
- diagnosis of obstructive sleep apnea requiring intervention
- required use of an assistive device for mobility (i.e. cane, wheelchair)
- BMI > 40
- hospitalization for a psychiatric disorder within the past 5 years
- those at risk for adverse cardiovascular events with moderate intensity activity
- those currently taking weight loss medication or committed to following an incompatible dietary regimen
- women who are pregnant, trying to get pregnant, or lactating
- Bulimia Nervosa
- suicide ideation
- current binge eating disorder
- those currently taking medications known to cause weight gain (i.e. Prednisone, Depakote, Diebeta, Diabinese, Cardura, Inderal, Zyprexa)
- current substance abuse or dependence
- plantar fasciitis
- current substance and/or alcohol dependence
- depression
- ADHD
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 factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Standard
Those randomized to the Standard condition will record everything they eat and will total their daily fat grams and calories on the "Keeping Track" form used in the DPP.
They will turn in their self-monitoring diaries and download their accelerometer (but not see those data) at weekly group sessions 1 through 8. Thereafter they will be expected to turn in paper data monthly, in person at the months 3 and 6 assessments and via mail, fax or e-mail for months 4 and 5. Accelerometer data will be downloaded at in-person visits.
|
Those randomized to the Standard condition will record everything they eat and will total their daily fat grams and calories on the "Keeping Track" form used in the DPP.
They will turn in their self-monitoring diaries and download their accelerometer (but not see those data) at weekly group sessions 1 through 8. Thereafter they will be expected to turn in paper data monthly, in person at the months 3 and 6 assessments and via mail, fax or e-mail for months 4 and 5. Accelerometer data will be downloaded at in-person visits.
|
Experimental: Technology Supported condition
Those randomized to the Technology Supported condition will record dietary intake and weight on the smartphone, using the user-friendly, persuasive interface developed in Phase I.
They will be expected to enter their dietary intake into the smartphone daily throughout the day.
They will also be expected to enter their weight and to wear the accelerometer daily.
Time-stamped data from the smartphone will upload automatically to the study server throughout the day, where it will be visible to the lifestyle coach.
The participant's real-time diet, activity, and weight data relative to goals will also be visually depicted on the participant's smartphone.
The anticipated web platform will be developed specifically for the ENGAGED participants.
The coach will provide feedback on diet and activity self-monitoring and goal adherence at least weekly by phone, e-mail or text during weeks 1-8 and then at least monthly through the 6 month follow-up.
|
Those randomized to the Technology Supported condition will record dietary intake and weight on the smartphone, using the user-friendly, persuasive interface developed in Phase I.
They will be expected to enter their dietary intake into the smartphone daily throughout the day.
They will also be expected to enter their weight and to wear the accelerometer daily.
Time-stamped data from the smartphone will upload automatically to the study server throughout the day, where it will be visible to the lifestyle coach.
The participant's real-time diet, activity, and weight data relative to goals will also be visually depicted on the participant's smartphone.
The anticipated web platform will be developed specifically for the ENGAGED participants.
The coach will provide feedback on diet and activity self-monitoring and goal adherence at least weekly by phone, e-mail or text during weeks 1-8 and then at least monthly through the 6 month follow-up.
|
Sin intervención: Self-Guided
Participants in the Self-Guided condition will receive DPP DVDs (3 DVDs and 1 CD) at the beginning of the study.
This condition will not receive any direct dietary or physical activity interventions outside of the DVDs.
Although Self-Guided participants will be receiving the same 7% weight loss goal as the other two groups, they will not be receiving physical activity or diet goals.
The DVDs cover the initial 12-weekly sessions of the DPP, with the sessions portrayed by professional actors.
They will also be provided with a supplemental DVD which includes a manual for each of the 12 sessions.
They will also be giving the Keeping Track booklets and asked to record their diet and activity daily.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Weight loss
Periodo de tiempo: 3 months, 6 months, 12 months
|
3 months, 6 months, 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Behavioral adherence
Periodo de tiempo: 3 months, 6 months
|
3 months, 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Bonnie Spring, Ph.D., Northwestern 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
- Spring B, Pellegrini CA, Pfammatter A, Duncan JM, Pictor A, McFadden HG, Siddique J, Hedeker D. Effects of an abbreviated obesity intervention supported by mobile technology: The ENGAGED randomized clinical trial. Obesity (Silver Spring). 2017 Jul;25(7):1191-1198. doi: 10.1002/oby.21842. Epub 2017 May 11.
- Pellegrini CA, Duncan JM, Moller AC, Buscemi J, Sularz A, DeMott A, Pictor A, Pagoto S, Siddique J, Spring B. A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial. BMC Public Health. 2012 Nov 30;12:1041. doi: 10.1186/1471-2458-12-1041.
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
1 de julio de 2011
Finalización primaria (Actual)
1 de mayo de 2013
Finalización del estudio (Actual)
1 de mayo de 2013
Fechas de registro del estudio
Enviado por primera vez
15 de enero de 2010
Primero enviado que cumplió con los criterios de control de calidad
15 de enero de 2010
Publicado por primera vez (Estimar)
18 de enero de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
11 de noviembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
10 de noviembre de 2016
Última verificación
1 de noviembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RC1DK087126-01 (Subvención/contrato del NIH de EE. UU.)
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. .
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