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Treating Adults at Risk for Weight Gain With Interactive Technology (TARGIT)

17 de junio de 2013 actualizado por: University of Tennessee

Targeted Approaches to Weight Control for Young Adults

Obesity represents a chronic disease associated with significant cardiovascular disease (CVD) morbidity and mortality. Weight gain in young adults adversely impacts the development of CVD risk factors. Further, there is a clear relationship between weight loss in obese persons and reduction in these CVD risk factors. Unfortunately, young adults are at high risk for weight gain. Although the scientific literature contains a number of reports regarding successful weight loss efficacy studies, young adults are typically underrepresented.

Cigarette smoking is the leading preventable cause of morbidity and mortality, but quitting smoking frequently results in significant weight gain. Proactive tobacco quit lines using behavioral smoking cessation interventions combined with nicotine replacement therapy (NRT) have been shown to help persons quit smoking. However, concerns about post-cessation weight gain have been reported as a significant barrier to quitting for many smokers particularly young adults.

If an efficacious behavioral weight loss program could be combined with an efficacious behavioral smoking cessation program that prevented or significantly attenuated post-cessation weight gain, then a large public health benefit may result. Such a combined weight loss/ weight gain prevention / smoking cessation program that used targeted intervention strategies to young adults, removed barriers to participation, and utilize interactive technology should be appealing to this age group. To date such a combined program has not been tested in young adult cigarette smokers. Therefore, the objective of this clinical trial is to develop and test a behavioral weight loss / weight gain prevention intervention delivered through interactive technology that can be used in conjunction with an efficacious tobacco quit line. A total of 330 participants will be necessary to adequately address the following specific aims.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

330

Fase

  • Fase 3

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

    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38163
        • Department of Preventive Medicine

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 35 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

The selection criteria for the clinical trial are designed to include a wide range of participants such that the study sample will be representative of the broader U.S. population of the Memphis metropolitan area. Those who might be at risk of adverse outcomes from the study interventions will be excluded (see exclusion criteria). All participants will give voluntary consent at the screening visit by signing an informed consent statement which has been approved by the Institutional Review Board (IRB). We will encourage the participation of women and minorities. The study will be open to all persons of any race or gender who are:

  1. *18 to 35 years old
  2. BMI > 22 kg / m2
  3. Self report smoking > 10 cigarettes each day
  4. Have access to a telephone and the internet
  5. Demonstrate ability to access a specific web site
  6. Demonstrate ability to receive and respond to email
  7. Willing to accept random assignment
  8. *Intending to be available for a 24 month intervention
  9. *At risk for weight gain (e.g. plan to quit smoking)

Exclusion Criteria:

Persons will be excluded from the TARGIT study for the following:

  1. *Current participation in a commercial weight loss program (e.g. Weight Watchers, Jenny Craig, etc.), current use of a prescription weight loss medication, planned weight loss surgery within the next 24 months (e.g. gastric bypass, lap band, or liposuction), current or planned enrollment in another diet / physical activity / weight loss study
  2. Currently meet recommendations for physical activity (i.e., 30 minutes or more of moderate physical activity per day on the majority of days each week - 150 minutes or more each week)
  3. *History of cerebral, coronary, or peripheral vascular disease, or serious uncontrolled cardiac arrhythmia, revascularization procedure or uncontrolled congestive heart failure in the past 6 months
  4. Current substance abuse (includes alcohol use in excess of 21 drinks a week)
  5. Uncontrolled hypertension as defined as BP > 140/90 mm Hg
  6. Presence of an unstable psychiatric condition or use of anti-psychotic drugs
  7. History of significant kidney disease or liver disease
  8. History of uncontrolled thyroid disease or pheochromocytoma
  9. Current use of a medication that may interfere with primary study endpoints (e.g. a weight loss medication such as Orlistat, etc) or that may increase the risk of side effects from the study intervention that can not be discontinued
  10. Severe uncontrolled asthma, bronchitis, or emphysema that precludes exercise
  11. Resting heart rate > 100
  12. *Malignancy in the last 5 years (except non-melanoma skin cancer)
  13. Plans to move from the Memphis metropolitan area in the next two years
  14. Current participation in another clinical trial
  15. *Other medical or behavioral factors, that in the judgment of the Principal Investigator, may interfere with study participation or the ability to follow the intervention protocol
  16. *History of diabetes treated with a medication that may cause hypoglycemia such as insulin or an oral hypoglycemic agent
  17. Known allergy or sensitivity to the nicotine patch
  18. *Currently pregnant or gave birth within the last 6 months, currently lactating or breast feeding within the last 3 months, actively planning pregnancy within the next 24 months
  19. *BMI < 18.5 kg / m2 or > 40 kg / m2
  20. *Have a household member on study staff
  21. *Current treatment for an eating disorder
  22. *Unable to provide informed consent
  23. *Regular use of a systemic steroids defined as taking the medication most days of the week
  24. *Use of medications to treat attention deficit disorder (ADD) or attention deficit hyperactivity disorder (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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Tobacco Quitline Group
All participants will receive a smoking cessation intervention via the Proactive TARGIT Quit Line. Participants will receive access to the TARGIT Smoking Cessation Handbook which will be a useful tool to guide them through the quitting process and highlight the major points reviewed in all counseling sessions. As part of TARGIT all participants will receive nicotine replacement therapy (NRT).
Experimental: Tobacco Quitline plus Interactive Technology Group
All participants will receive a smoking cessation intervention via the Proactive TARGIT Quit Line. Participants will receive access to the TARGIT Smoking Cessation Handbook which will be a useful tool to guide them through the quitting process and highlight the major points reviewed in all counseling sessions. As part of TARGIT all participants will receive nicotine replacement therapy (NRT). Participants in the Intervention Group will also receive a Behavioral Weight Loss/ Weight Gain Prevention Intervention delivered via interactive technology. The Intervention group will receive 16 weekly webinar sessions beginning 7 weeks after randomization via Cisco WebEx. The webinar sessions will present the behavioral weight loss/ weight gain prevention program. After the 16 weekly sessions, the webinar sessions will then be scheduled monthly for the next 6 months then quarterly thereafter for 12 months.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Body Mass Index
Periodo de tiempo: 24 months after randomization
24 months after randomization

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Smoking status
Periodo de tiempo: 24 months after randomization
24 months after randomization

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Karen Johnson, MD, MPH, University of Tennessee

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.

Enlaces Útiles

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 agosto de 2009

Finalización primaria (Anticipado)

1 de octubre de 2014

Finalización del estudio (Anticipado)

1 de octubre de 2014

Fechas de registro del estudio

Enviado por primera vez

9 de septiembre de 2010

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2010

Publicado por primera vez (Estimar)

10 de septiembre de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

18 de junio de 2013

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

17 de junio de 2013

Última verificación

1 de junio de 2013

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1U01HL096628 (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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