Comparison of Weight Loss Programs for Individuals With Severe Obesity

Comparison of a Traditional Behavioral Weight Loss Program Versus a Technology - Based Weight Loss Program in Severely Obese Individuals

Patrocinadores

Patrocinador principal: The Miriam Hospital

Fuente The Miriam Hospital
Resumen breve

The purpose of this study is to evaluate the effectiveness of a technology-based system (the Body Media FIT system) for enhancing weight loss in severely obese individuals (BMI: ≥ 40 kg/m2). The investigators will compare two 6-month interventions: 1) a standard behavioral weight loss program (SBT) and 2) a standard behavioral weight loss program plus the use of the Body Media FIT system (SBT+FIT). The Body Media® FIT system is a novel weight loss tool consisting of an armband that measures energy expenditure, a digital display watch that provides "real time" physical activity and energy expenditure feedback, and access to a system website which allows individuals to track their food intake and set exercise and dietary goals. We will examine differences in physical activity, weight loss, and program adherence between groups.

Estado general Completed
Fecha de inicio March 2011
Fecha de Terminación October 2011
Fecha de finalización primaria October 2011
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change in body weight 6-months
Resultado secundario
Medida Periodo de tiempo
Change in physical activity 6-months
Inscripción 29
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Standard behavioral treatment

Descripción: Participants receive a standard behavioral weight loss program similar to that used in other large trials such as Look AHEAD and the Diabetes Prevention Program. Individuals will come to weekly group meetings for 6-months and will be instructed to reduce caloric intake, increase physical activity, and self-monitor their weight, eating, and exercise behaviors.

Etiqueta de grupo de brazo: Standard behavioral treatment (SBT)

Tipo de intervención: Behavioral

Nombre de intervención: SBT + technology system (SBT+FIT)

Descripción: Participants will receive a standard behavioral weight loss program and will also be asked to use the Body Media FIT system as part of their weight loss intervention. Individuals will come to weekly group meetings for 6-months and will be instructed to reduce caloric intake, increase physical activity, and self-monitor their weight, eating, and exercise behaviors. Participants in this group will also wear an armband that measures energy expenditure and they will log their food intake on the internet.

Etiqueta de grupo de brazo: SBT + technology system (SBT+FIT)

Elegibilidad

Criterios:

Inclusion Criteria:

- Age 21-55

- Body mass index (BMI) ≥40kg/m2 (or no more than 440 lbs)

Exclusion Criteria:

- Recent weight loss (≥ 10 pounds within the past 6 months)

- Currently pregnant, pregnant within the last 6 months, or planning on becoming pregnant in the next 6 months.

- Presence of any condition that would limit exercise participation (assessed by the Physical Activity Readiness Questionnaire (PAR-Q)).

- A history of myocardial infarction or other heart-related surgeries.

- Currently enrolled in a commercial weight loss program.

- A recent (< 1 year) diagnosis or hospitalization for a psychological condition or history of psychosis (e.g. - Schizophrenia, Bipolar, Eating Disorder)

- Diagnosed with cancer within the past year or currently undergoing cancer treatment.

- Currently taking weight loss medications.

- Currently do not have daily access to a computer or Internet.

- Individuals with diabetes

Género: All

Edad mínima: 21 Years

Edad máxima: 55 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Rena Wing, PhD Principal Investigator The Miriam Hospital
Ubicación
Instalaciones: Weight Control and Diabetes Research Center
Ubicacion Paises

United States

Fecha de verificación

April 2012

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: The Miriam Hospital

Nombre completo del investigador: Jessica Unick

Título del investigador: Assistant Professor (Research)

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: SBT + technology system (SBT+FIT)

Tipo: Experimental

Descripción: Participants will receive a standard behavioral weight loss program and will also be asked to use the Body Media FIT system as part of their weight loss intervention.

Etiqueta: Standard behavioral treatment (SBT)

Tipo: Experimental

Descripción: Participants receive a standard behavioral weight loss program similar to that used in other large trials such as Look AHEAD and the Diabetes Prevention Program.

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov