- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02088294
Guided Imagery Lifestyle Intervention to Promote Health and Prevent Diabetes in Youth
12 de octubre de 2018 actualizado por: Marc Weigensberg, University of Southern California
Imagine HEALTH (Healthy Eating Active Living Total Health) Study: Guided Imagery Lifestyle Intervention to Promote Health and Prevent Diabetes in Youth
The childhood obesity epidemic, which falls disproportionately on Latino adolescents, represents a major public health threat to the current generation of youth, and therefore to the health of the nation overall.
This project directly addresses the role of psychosocial stress in promoting obesity and metabolic disease risk, and investigates the role of the mind-body CAM intervention of guided imagery in both reducing stress and promoting healthy lifestyle behaviors that could dramatically improve the metabolic health of today's youth.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
The childhood obesity epidemic represents a major health threat to the current generation of youth, and falls disproportionately on urban, Latino adolescents.
Data suggests modern inner-city minority youth suffer from high levels of psychosocial stress, and that such chronic stress contributes to obesity and insulin resistance, increasing risk of type 2 diabetes, cardiovascular disease, fatty liver disease, and other obesity-related disorders.
Guided imagery is a mind-body complementary/alternative medicine (CAM) modality that offers promise as a therapeutic intervention to reduce psychosocial stress, and also to promote healthy lifestyle behaviors.
In a pilot 12-week lifestyle intervention, Interactive Guided ImagerySM significantly reduced salivary cortisol, reduced sedentary behavior, and increased moderate physical activity in overweight Latino adolescents.
The overall aim of this proposal is to determine the separate contributions of stress reduction guided imagery and health behavior guided imagery, when delivered in the context of a health-promoting, lifestyle intervention, on short-term and long-term stress-reduction and behavioral outcomes in predominantly Latino high school students.
The study consists of a high school-based, 12-week lifestyle intervention delivered in an after school program to urban, predominantly Latino adolescents.
The intervention features a health-promoting, lifestyle education class, combined with a group guided imagery intervention that is theoretically grounded in Self-Determination Theory (SDT).
High school students are randomized to one of 4 intervention arms 1) Non-intervention control; 2) lifestyle education alone (LS); 3) LS + Stress Reduction guided imagery alone; 4) LS + Physical Activity/Healthy Eating guided imagery.
Outcomes will be measured upon completion of the 12-wk intervention, after an additional 6-month maintenance program, and after a further 6-month period of no program contact.
Primary outcomes will be change in salivary cortisol patterns and changes in physical activity and dietary intake.
Secondary outcomes are insulin resistance, body fat, carotid intima media thickness, metabolic syndrome, perceived stress, well-being (self-esteem, health related quality of life), and measures of mediation by SDT constructs.
Results will demonstrate the isolated effects of the lifestyle education and the two different forms of guided imagery, and could shift the paradigm of obesity prevention and treatment in urban minority youth to include attention to social stress and promotion of well-being.
Tipo de estudio
Intervencionista
Inscripción (Actual)
240
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
-
-
California
-
Los Angeles, California, Estados Unidos, 90033
- University of Southern California
-
-
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
14 años a 17 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male and female enrolled in second year (i.e. sophomore year) of high school at time of consent into study, junior year at time of intervention
- Self-stated intent to complete high school
- Predominantly minority ethnicity (self-reported)
- Overweight/ obese and normal weight
- Agreement to attend up to 3 after school classes per week for the 12 weeks of the program
Exclusion Criteria:
- Serious chronic illness or physical, cognitive, or behavioral disability that would prevent ability to fully receive intervention
- Prior diagnosis of clinical eating disorder, psychiatric disorder, or significant cognitive disability
- Lack of English fluency
- Participation in previous "Council" programs offered through the school
- Participation in formal weight-loss programs in 3 months preceding entry to study
- Pregnancy
- Sibling or other household member enrolling for the intervention
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: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Non-intervention control
No intervention will be delivered.
|
|
|
Experimental: Lifestyle Education (LS)
The lifestyle curriculum will be taught in twice weekly after-school sessions of ~1.25 hours, one physical activity and one nutrition-related, delivered over 12-weeks during the course of a single academic semester.
The lifestyle program will utilize the "Shape Up" curriculum of SOSMentor, a community non-profit collaborator, modified to seamlessly integrate key concepts of the non-diet philosophy of "Intuitive Eating".
The curriculum fully encompasses health-promoting nutrition and physical activity practices consistent with consensus recommendations .
|
See arm description
|
|
Experimental: LS + Stress Reduction Guided Imagery
In addition to the after school lifestyle classes, participants will receive group Interactive Guided Imagery (IGI) consisting of standard stress reduction imagery practices, delivered once weekly for 12 weeks as an after school class of ~1.25 hours.
The group IGI will be delivered by certified facilitators in the context of the facilitated group process known as "Council", a group communication process used by many indigenous and other cultures.
|
See arm description
See Arm Description
|
|
Experimental: LS + Activity/Eating Guided Imagery
In addition to the after school lifestyle classes, participants will receive group Interactive Guided ImagerySM (IGI) delivered once weekly for 12 weeks as an after school class of ~1.25 hours.
The group IGI will be delivered by certified facilitators in the context of the facilitated group process known as "Council", a group communication process used by many indigenous and other cultures.
Participants in this arm will receive stress reduction IGI for 4 wks, plus 8 weekly sessions with IGI content designed to promote physical activity and healthy eating.
|
See arm description
See arm description
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Physical activity
Periodo de tiempo: 3 months
|
Physical activity and sedentary behavior will be measured by accelerometry and 3-day physical activity recall.
|
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Salivary Cortisol, daily slope
Periodo de tiempo: 3 months
|
Salivary cortisol will be collected on 3 successive days at awakening, 30-minutes post-awakening, and in the evening.
|
3 months
|
|
Change in Dietary intake
Periodo de tiempo: 3 months
|
Dietary intake of macronutrients measured by 3-day diet record
|
3 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Perceived Stress
Periodo de tiempo: 3 months
|
Measured by Perceived Stress Scale
|
3 months
|
|
Change in Well-Being
Periodo de tiempo: 3 months
|
Measured by Psychological General Well-Being Index (GWBS) and the Arizona Integrated Outcomes Scale.
|
3 months
|
|
Change in Adiposity
Periodo de tiempo: 3 months
|
BMI will be determined based on standards for age and sex, using clinical balance and stadiometer.
Percent body fat will be determined by bioimpedance.
|
3 months
|
|
Change in Insulin resistance
Periodo de tiempo: 3 months
|
The Homeostatic Model Insulin Resistance Index will be determined based on measures of fasting glucose and insulin.
|
3 months
|
|
Change in Carotid artery intima media thickness
Periodo de tiempo: 15 months
|
Determined by carotid artery ultrasound.
|
15 months
|
|
Change in Self-determination Theory Constructs
Periodo de tiempo: 3 months
|
Constructs of SDT will be assessed as theoretical mediators of intervention effects using the following survey measures: Perceived Competence for Participating in Regular Physical Activity (PCSPA) and for Healthy Eating (PCSHE); Health Care Climate Questionaire to determine autonomy support; Exercise Self-Regulation Questionnaire and Treatment Self-Regulation Questionnaire to determine autonomous motivation for physical activity and healthy eating; Group Cohesion Scale to assess relatedness.
|
3 months
|
|
Change in Intuitive eating
Periodo de tiempo: 3 months
|
Intuitive Eating Scale measures attitudes and behaviors relating to intuitive eating.
|
3 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
- Bell BM, Spruijt-Metz D, Naya CH, Lane CJ, Wen CKF, Davis JN, Weigensberg MJ. The mediating role of emotional eating in the relationship between perceived stress and dietary intake quality in Hispanic/Latino adolescents. Eat Behav. 2021 Aug;42:101537. doi: 10.1016/j.eatbeh.2021.101537. Epub 2021 Jun 30.
- Weigensberg MJ, Avila Q, Spruijt-Metz D, Davis JN, Wen CKF, Goodman K, Perdomo M, Wade NB, Ding L, Lane CJ. Imagine HEALTH: Randomized Controlled Trial of a Guided Imagery Lifestyle Intervention to Improve Obesity-Related Lifestyle Behaviors in Predominantly Latinx Adolescents. J Altern Complement Med. 2021 Sep;27(9):738-749. doi: 10.1089/acm.2020.0515. Epub 2021 May 25.
- Weigensberg MJ, Spruijt-Metz D, Wen CKF, Davis JN, Avila Q, Juarez M, Brown-Wade N, Lane CJ. Protocol for the Imagine HEALTH Study: Guided imagery lifestyle intervention to improve obesity-related behaviors and salivary cortisol patterns in predominantly Latino adolescents. Contemp Clin Trials. 2018 Sep;72:103-116. doi: 10.1016/j.cct.2018.07.009. Epub 2018 Aug 2.
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 mayo de 2014
Finalización primaria (Actual)
27 de abril de 2018
Finalización del estudio (Actual)
31 de julio de 2018
Fechas de registro del estudio
Enviado por primera vez
26 de febrero de 2014
Primero enviado que cumplió con los criterios de control de calidad
12 de marzo de 2014
Publicado por primera vez (Estimar)
14 de marzo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de octubre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
12 de octubre de 2018
Última verificación
1 de octubre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NCCAM 1 RO1 AT008330-01
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. .