- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01208870
Translating Habituation Research to Interventions for Pediatric Obesity (EAT)
1 de octubre de 2020 actualizado por: Leonard Epstein, State University of New York at Buffalo
The purpose of this center grant is to translate basic behavioral science on habituation theory into clinical intervention using a vertical hierarchical approach from laboratory studies to field studies to the clinical intervention to improve weight loss outcomes in pediatric obesity treatment.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Habituation is one factor that may be related to excess energy intake.
Research has shown that the rate of habituation is inversely related to the amount of food consumed and slower habituation may be a factor that is relevant to obesity, as overweight youth and adults habituate slower and consume more energy than their peers.
Habituation is a basic form of learning that is observed in many response systems.
We believe that habituation is an important process that mediates food regulation during a meal and across meals.
However, there has been no research in children that translates basic research on habituation to food into clinical interventions for pediatric obesity.
In the first phase, we will implement a series of laboratory studies to assess the effects of stimulus specificity and variety and the simultaneous reduction of variety for high energy density foods on short (within meal) and long-term (across meal) habituation.
The second phase is designed to implement a series of field studies that will extend basic research from the first phase as well as define the optimal interval for reducing variety to facilitate long-term habituation to high energy density foods in the natural environment.
The third phase is designed to develop and pilot test a family-based behavioral intervention for children that incorporates findings from phase2 into a clinical intervention.
Tipo de estudio
Intervencionista
Inscripción (Actual)
94
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
-
-
New York
-
Buffalo, New York, Estados Unidos, 14214
- University at Buffalo, Department of Pediatrics, Division of Behavioral 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
8 años a 12 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Children ages 8-12 years of age
- At or above 85th BMI percentile
- Children must eat almost all meals with the exception of school lunch with the family.
- Overweight parent
Exclusion Criteria:
- Children who do not like the study foods, who are allergic to the study foods or who are on special diets and cannot consume the study foods.
- Families with children with a co-morbid psychiatric diagnosis or parents who are depressed, have schizophrenia, substance abuse or a history of eating disorders.
- The parent and child must not have any physical restrictions that would preclude them from making the requisite behavioral changes.
- Children must be able to read at a 3rd grade reading level and must be able to demonstrate the ability to keep dietary and activity records in a stimulated interview.
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 paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Variety Group
Traditional family based weight control treatment program with components to reduce variety of high energy dense foods incorporated into the treatment.
Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 behavioral intervention sessions.
|
The intervention will consist of our traditional family based weight control intervention with elements of reducing variety of high energy dense foods for the variety group.
The intervention will consist of our traditional family based weight control intervention.
|
Experimental: Nutrition Education Control
Traditional family based weight control treatment program, without components from habituation theory incorporated into the treatment.
Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 behavioral intervention sessions.
|
The intervention will consist of our traditional family based weight control intervention.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change of Child Body Composition
Periodo de tiempo: Baseline to 6 months
|
Child percent overweight difference from baseline to 6 month.
The formula used to derive weight loss percentage was weight lost at 6 months divided by starting weight, multiplied by 100.
|
Baseline to 6 months
|
Change Parent Body Composition
Periodo de tiempo: Baseline to 6 months
|
Parent Body Mass Index (kg/m^2) difference from baseline to 6 months
|
Baseline to 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Dietary Intake of Calories
Periodo de tiempo: Baseline to 6 months
|
Energy intake was calculated for parents and children as the different from baseline to six months of calories consumed.
The first pilot used the calories generated from the Food Frequency Questionnaire (FFQ) report however the second pilot used calories from 24 hour recalls based on the Center of Disease Control data base or food labels.
|
Baseline to 6 months
|
Change in Parent Delay Discounting
Periodo de tiempo: Baseline to 6 months
|
Kirby, small, medium and large reinforcers.
The Kirby monetary choice questionnaire will be used to measure implusivity in parents and children.
Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards.
An estimate of the participant's discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in K-values.
(0.25 impulsive to 0.00016 not impulsive)
|
Baseline to 6 months
|
Change in Child Delay Discounting
Periodo de tiempo: Baseline to 6 months
|
Kirby, small, medium and large reinforcers.
The Kirby monetary choice questionnaire will be used to measure impulsivity in parents and children.
Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards.
An estimate of the participant's discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in higher K-values (0.25 vs 0.00016).
|
Baseline to 6 months
|
Changes in Variety Measures
Periodo de tiempo: Baseline to 6 months
|
Variety of high energy density foods (RED) and low energy density foods (GREEN) were calculated from the Food Frequency Questionnaire (FFQ) for pilot 1 and 24 hour recalls (24-HR) for pilot 2. High energy dense food or Red foods are low in nutrient density.
Most Red foods come from the Fats, Oils and Sweets groups and are to be used sparingly.
Modified foods from the Fats, Oils, and Sweets group are still considered to be Red foods, even if their energy level is low.
These foods contribute little nutrients to the diet and compete for consumption of healthier foods.
Green foods are high in nutrient density and low in energy density.
Most Green foods come from the fruit and vegetable groups.
Serving sizes were based off the serving sizes used in United States Department of Agriculture (USDA) common serving sizes.
Coding was based on the serving sizes of the specified food items and used to calculate the changes from baseline to six months.
|
Baseline to 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Leonard H. Epstein, Ph.D., SUNY Buffalo
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
- Epstein LH, Kilanowski C, Paluch RA, Raynor H, Daniel TO. Reducing variety enhances effectiveness of family-based treatment for pediatric obesity. Eat Behav. 2015 Apr;17:140-3. doi: 10.1016/j.eatbeh.2015.02.001. Epub 2015 Feb 13.
- Epstein LH, Fletcher KD, O'Neill J, Roemmich JN, Raynor H, Bouton ME. Food characteristics, long-term habituation and energy intake. Laboratory and field studies. Appetite. 2013 Jan;60(1):40-50. doi: 10.1016/j.appet.2012.08.030. Epub 2012 Oct 22.
- Epstein LH, Carr KA, Cavanaugh MD, Paluch RA, Bouton ME. Long-term habituation to food in obese and nonobese women. Am J Clin Nutr. 2011 Aug;94(2):371-6. doi: 10.3945/ajcn.110.009035. Epub 2011 May 18.
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 octubre de 2009
Finalización primaria (Actual)
1 de marzo de 2014
Finalización del estudio (Actual)
1 de marzo de 2014
Fechas de registro del estudio
Enviado por primera vez
23 de septiembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
23 de septiembre de 2010
Publicado por primera vez (Estimar)
24 de septiembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de octubre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
1 de octubre de 2020
Última verificación
1 de octubre de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1083316-1-52205
- 5U01DK088380 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared under the specifics of this protocol.
Outcome data will be published.
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. .
Ensayos clínicos sobre Variety Group
-
University of LisbonAssociacao Protectora dos Diabeticos de PortugalTerminado
-
Arizona Oncology ServicesDesconocidoCáncer de mama localizado | Cáncer de próstata localizado | Pacientes que reciben radioterapia de haz externoEstados Unidos
-
University of TennesseeNational Cancer Institute (NCI); Regional One HealthReclutamientoPérdida de peso | Sobrepeso y Obesidad | Comportamiento, SaludEstados Unidos
-
Boston Children's HospitalTerminadoEstrés Psicológico | Problema de aculturaciónEstados Unidos
-
Aydin Adnan Menderes UniversityAún no reclutando
-
Aydin Adnan Menderes UniversityAún no reclutandoEducación | Estudiantes de EnfermeríaPavo
-
Amsterdam UMC, location VUmcRed Cross Hospital BeverwijkTerminadoCicatriz Hipertrófica | QueloidePaíses Bajos
-
Centre hospitalier de l'Université de Montréal...University Health Network, Toronto; University of British Columbia; McGill University y otros colaboradoresReclutamientoEnfermedades urológicasCanadá, Estados Unidos
-
Amasya UniversityAún no reclutandoSoledad | Danzaterapia | Auto abandonoPavo
-
Shanghai MicroPort Rhythm MedTech Co., Ltd.ReclutamientoPerforación de la arteria coronariaPorcelana