Estudio de pérdida de peso en adultos jóvenes
Una nueva intervención para bajar de peso en adultos jóvenes
Obesity and cardiometabolic risks are significant public health issues, with about two-thirds of U.S. adults overweight or obese. Weight loss can prevent these health problems, but current lifestyle interventions have limited success. New, effective strategies are needed to address this rising issue at the population level. The goal of this clinical trial is to investigate how a behavioral intervention combined with technology impacts weight loss in young adults. The main questions it aims to answer are:
• How does the combination of behavioral intervention and technology influence weight loss in young adults?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study team is seeking volunteers to participate in a research study to help better understand how a behavioral intervention combined with technology may impact weight loss. Participation will span approximately 6 months. Participants will be required to attend up to 5 visits at the University of Chicago. Those visits will include daytime visits to a clinic involving fasted blood draws and completion of surveys. During the study, participants will regularly record their weight using a digital scale, input their daily food intake into a smartphone app, and wear a wrist activity monitor to track their physical activity. Participants will also be paired with a trained coach to guide and assist their progress over their 6 months of participation.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Olivia Hughes
- Número de teléfono: 7737022348
- Correo electrónico: bhughes8@bsd.uchicago.edu
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- Reclutamiento
- University of Chicago
-
Investigador principal:
- Esra Tasali, MD
-
Contacto:
- UChicago IRB
- Número de teléfono: 773-702-6505
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Overweight or obese (BMI 25.5- 34.9 kg/m2) men and women
- Ages 18 to 40 years
- Weight stable (no change >25 lbs in the past 3 months)
- Owns a smartphone and willing to install the study app
Exclusion Criteria:
- Presence of obstructive sleep apnea or history of any other sleep disorder.
- Irregular menses, menopausal symptoms or post-menopausal, currently pregnant, trying to get pregnant or nursing
- Regular travel across time zones
- Subjects who are currently following a weight loss regimen or any other special diet or exercise programs
- Increased fractional lean body mass (e.g., athletes)
- Unable to walk, using an assistive device for mobility, or any contraindications to exercise
- Diabetes
- Claustrophobia
- Excessive alcohol (>2 drinks/day) or caffeine (>300mg/day) intake, regular nicotine use, substance abuse.
- Abnormal findings on screening blood testing.
- Participants taking any prescription, over-the-counter drugs/supplements that can affect sleep or weight.
- Major psychiatric or any eating disorder, and any acute or chronic medical condition that increase the risk of interventions (e.g., heart disease)
- Any underlying disease likely to limit life span and/or increase risk of interventions including cardiovascular disease (e.g. unstable angina, heart failure requiring hospitalization in the past 6 months, significant heart block or arrhythmias, NYHA Class>2), pulmonary disease with dependence on oxygen or daily use of bronchodilators, cancer requiring treatment in the past 5 years unless the prognosis is considered good, active or chronic infection, thyroid disease and other endocrine disorders (e.g. Cushing syndrome, acromegaly), hepatitis or other chronic gastrointestinal disease (pancreatitis, inflammatory bowel disease), renal disease, significant anemia, recent surgery or significant abdominal surgery, major psychiatric or any eating disorder, acute coronary syndrome or stroke in the past 6 months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Lifestyle Intervention
Diet and exercise coaching |
All participants will receive diet and exercise goals and coaching. |
|
Experimental: Lifestyle Intervention II
Diet and exercise coaching |
All participants will receive diet and exercise goals and coaching. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Weight loss
Periodo de tiempo: Baseline and 6 months
|
Change in weight [kg] at 6 months. Weight will be measured by research staff during each visit in the morning in duplicate in the fasted state after voiding using calibrated digital scales, wearing a hospital gown. |
Baseline and 6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Esra Tasali, MD, University of Chicago
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB23-1677
- 1R01DK136214-01A1 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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