Eating RePace Study (REPACE)
Eating Pace Retraining in Childhood Obesity Prevention
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Childhood obesity is one of nation's foremost public health epidemics, for which more potent and enduring prevention interventions are needed. The goal of this program of research is to study novel methods which may help to prevent childhood obesity. The purpose of this randomized, controlled pilot study is to retrain children at risk for obesity (4-7 years of age in the 65th - <96th BMI percentile for age and sex, who have rapid eating and an obese participating parent/legal guardian [ N = 15]) to reduce their rate of eating (mouthfuls/minute) during a laboratory test meal, compared with participants in usual care control condition (UCC),which receives a brief educational intervention to promote healthy eating after the final assessment) (N=15). Between group change scores in mouthfuls/min (baseline Lab meal 1 to Lab meal 2) will be assessed. The investigators hypothesize that the children in the Re-Pace group will have a greater reduction in the rate of eating (mouthfuls of food/min) from baseline to week 6, compared to those in the UCC group.
As the sample size is relatively small, the aim is to develop an "effect size estimation," i.e., to generate an effect size that will be used to power an extramural grant application. Specifically, the investigators will generate Cohen's D as the effect size estimate, which is calculated as the difference in the group means divided by the pooled standard deviation. Cohen's D is an established quantitative measure for effect size estimation and informing power analysis for study design.
In addition, this study's objective is to develop and pilot a novel family-based eating behavior program for a prevention intervention in at risk children.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
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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:
Children:
- Males or females 4 to 7 years of age.
- Participants (the children) have a body mass index (BMI) for age and sex between the 65th-<96th percentile (thus, the children will not have a BMI at the 97th percentile or more).
- Parental/guardian permission (informed consent).
- Have an overweight or obese participating parent/guardian with a BMI of > 27 kg/m2
- Increased child eating rate as reported on the questionnaire (Child Eating Behavior Questionnaire) by the parent/guardian
Parents:
- Parent/legal guardian of subject.
- Age 21 years and above.
- Have a BMI of > 27 kg/m2.
Exclusion Criteria:
Children:
- Children who have any developmental, medical, or psychiatric condition which might affect study compliance, as described by parental (caregiver) report.
- Children who have serious medical conditions or use of medications (e.g., chronic oral steroids, antipsychotic medications) known to affect food intake or body weight, as described by parental report.
- Children who have food allergies which may influence consumption of test foods, as reported by the parent; any child with reported peanut allergy.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Parents:
- Parents/guardians who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: RePace Intervention Group
Re-Pace intervention-five weekly intervention sessions lasting about 1 hour each. Lab Test Meal-2 test meals 6-8 weeks apart. |
The Re-Pace intervention will provide children and parents/caregivers training in strategies to promote slower eating pace and greater awareness of satiety levels.
These skill building strategies can be classified as follows: 1) learning to slow eating rate, 2) awareness-raising activities; 3) role play activities; 4) self-monitoring training; 5) goal setting challenges; and 6) parent training.
A core strategy for achieving slower eating pace and improved satiety will be to increase fruit and vegetable intake to meet United States Department of Agriculture (USDA) guidelines (www.myplate.gov).
There are 5 intervention visits lasting about 1 to 1.25 hours each.
See Section 4.3.1 for more details of the Re-Pace intervention.
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|
Comparador activo: Usual Care Control Group
One 25 minute education session (week 6) 2 lab test meals 6-8 weeks apart (baseline and week 6)
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Following the second test meal session, parents and children will receive a brief (25 minute) instruction on healthy eating using materials from www.ChooseMyPlate.gov
site, including "What's on Your Plate" and "My Plate for Kids" mini-posters.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reduction of eating rate (mouthfuls/min)
Periodo de tiempo: 6 weeks
|
The purpose of this randomized, controlled pilot study is to retrain children at risk for obesity (4-7 years of age in the 65th - <96th BMI percentile for age and sex, who have rapid eating and an obese participating parent/legal guardian [ N = 15]) to reduce their rate of eating (mouthfuls/minute) during a laboratory test meal, compared with participants in usual care control condition (UCC),which receives a brief educational intervention to promote healthy eating after the final assessment) (N=15).
Between group change scores in mouthfuls/min (baseline Lab meal 1 to Lab meal 2) will be assessed.
We hypothesize that the children in the Re-Pace group will have a greater reduction in the rate of eating (mouthfuls of food/min) from baseline to week 6, compared to those in the UCC group.
|
6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reduction of food consumption
Periodo de tiempo: 6 weeks
|
Reduce the rate of food consumption (kcal/min) and total kcal intake during the test meals (baseline Lab Meal 1 to Lab Meal 2).
We also aim for participants to consume more fruits and vegetables during the test meal (baseline to week 6).
|
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robert I Berkowitz, MD, Children's Hospital of Philadelphia
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- 12-009540
Información sobre medicamentos y dispositivos, documentos del estudio
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