Garden-fresh Produce and Exercise Reduce Colon Cancer Risk (GFPE)
4 de junio de 2019 actualizado por: William J. McCarthy, Ph.D., University of California, Los Angeles
Garden-fresh Produce and Exercise Reduce Colon Cancer Risk by Reducing Central Obesity and Increasing Stool Quality
The investigators propose a church-based health promotion program designed to reduce colon cancer risk in a mostly African American community served by the Lincoln Memorial Church in South Los Angeles.
The investigators propose involving 20 overweight/obese community members in a 10-session health promotion program featuring weekly cooking classes, didactic nutrition instruction and brief bouts of exercise.
Behavioral aim is to increase participants' fiber intake from commonly consumed plant foods and reduce their intake of pro-inflammatory foods.
They will be followed for 3 months from time of enrollment.
Intervention is expected to increase participants' mean stool weight and improve their Bristol Stool Chart score.
Intervention is expected to reduce waist circumference and systolic blood pressure of participants.
These effects are expected to be accompanied by self-reports of increased fiber intake and reduced intake of saturated fat and refined sugar as well as evidence of increased physical activity.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
The investigators propose a church-based health promotion program designed to reduce colon cancer risk in a mostly African American community served by the Lincoln Memorial Church in South Los Angeles.
The Los Angeles County of Public Health has divided the county into nine service planning areas (SPAs), of which South LA is one.
Of all the SPAs, the South LA SPA has the highest prevalence of obesity and the lowest adherence to federal nutrition recommendations.
With seed grant funds from a cooperative NIH grant shared by the Drew School of Medicine and University of California-Los Angeles (UCLA), the Lincoln Memorial Church of Los Angeles is sponsoring a behavioral intervention featuring 10 weekly sessions composed of cooking demonstrations, brief didactic nutrition education and 10-minute exercise bouts.
All sessions will take place in the church kitchen and meeting room.
Participants are expected to be 20 mostly African American, overweight/obese community members.
The behavioral goal of the health promotion sessions is to encourage participants to eat more fiber-rich plant foods, minimally processed, to consume fewer pro-inflammatory foods including foods rich in saturated fat, sodium and refined sugar, and to engage in federally recommended amounts of physical activity.
If research resources become available to enable blood chemistry results and/or fecal metagenomic results, the investigators would predict that 3 months after participant enrollment in the study, participants would experience a reduction in their high-sensitivity-C-reactive protein concentration and an increase in the relative abundance of obligate anaerobic bacteria relative to other bacteria in fecal samples.
As seems likely, however, results will be limited to evaluating the weight and form of participant stool samples using the Bristol Stool Chart and evaluating participants' waist circumference and systolic blood pressure.
The 3 month follow-up assessment is expected to show increased stool weight, improved Bristol Stool Chart score, decreased waist circumference, decreased systolic blood pressure, reduced intake of saturated fat and refined sugar, and increased weekly physical activity.
Tipo de estudio
Intervencionista
Inscripción (Actual)
21
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
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California
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Los Angeles, California, Estados Unidos, 90095-6900
- UCLA Center for Cancer Prevention & Control Research
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- body mass index > 25 > 40.
- must reside within 5 miles of the Lincoln Memorial Congregational Church
- must understand English
Exclusion Criteria:
- Crohns disease, ulcerative colitis or irritable bowel syndrome
- currently taking any prescription medication likely to cause weight gain or weight loss
- Currently taking medication for diabetes (e.g., metformin, insulin)
- Had a heart attack in the last 12 months
- Ever had bariatric surgery (weight loss surgery)
- Have been hospitalized for a mental health problem in the last 12 months
- Are currently pregnant or breastfeeding
- Currently use tobacco products such as cigarettes, electronic cigarettes
- Currently use marijuana products, including edibles
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: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Garden-fresh produce and exercise (GFPE)
Participants are encouraged to double their consumption of minimally processed fiber-rich plant foods, especially garden-fresh produce from the church community garden.
Participants are also encouraged to limit pro-inflammatory foods rich in saturated fat, sodium and added sugar.
Participants are also encouraged to engage in 150 minutes of moderate to vigorous physical activity per week, most likely in the form of brisk walking.
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The Garden-fresh produce and exercise (GFPE) health promotion intervention features 10 weekly sessions that take place after Sunday services in the Lincoln Memorial Church kitchen/meeting space.
Each session includes a cooking demonstration focused on how to prepare and cook a meal composed of fiber-rich plant foods minimally processed.
Each session also includes brief, didactic nutrition instruction and a 10-minute bout of physical activity.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Stool weight
Periodo de tiempo: At baseline and 3 months post-enrollment
|
Mean stool weight of single bowel evacuation using precision digital scale
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At baseline and 3 months post-enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Bristol Stool Chart score
Periodo de tiempo: At baseline and 3 months post-enrollment
|
Bristol Stool Chart score ranges from 1 (hard lumps) to 7 (soft, diarrhea, liquid)
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At baseline and 3 months post-enrollment
|
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Waist circumference
Periodo de tiempo: At baseline and 3 months post-enrollment
|
Waist circumference measured over light clothing using tensioner-equipped waist circumference measuring device
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At baseline and 3 months post-enrollment
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Systolic blood pressure
Periodo de tiempo: At baseline and 3 months post-enrollment
|
Resting blood pressure assessed in participant seated quietly at a table with legs uncrossed
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At baseline and 3 months post-enrollment
|
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Ratio of fruit and vegetable fiber intake to total solid food intake
Periodo de tiempo: At baseline and 3 months post-enrollment
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The ratio of fruit and vegetable fiber intake relative to total gram weight of foods consumed per day based on data from Block Food Frequency questionnaire.
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At baseline and 3 months post-enrollment
|
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Saturated fat intake
Periodo de tiempo: At baseline and 3 months post-enrollment
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Mean grams (g) of saturated fat intake consumed daily based on retrospective food consumption data obtained from administration of the Block Food Frequency questionnaire.
The Daily Value for saturated fat is less than 20 g per day, based on a 2,000 calorie diet.
Meat-eating Americans generally consume more than 20 g per day but usually don't exceed 80 g per day.
Humans make all the saturated fat that they need, so consuming zero g of saturated fat per day is consistent with good health.
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At baseline and 3 months post-enrollment
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Sugary beverage intake
Periodo de tiempo: At baseline and 3 months post-enrollment
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Percent of daily calorie intake attributable to sugary beverage intake
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At baseline and 3 months post-enrollment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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)
17 de marzo de 2019
Finalización primaria (Anticipado)
30 de julio de 2019
Finalización del estudio (Anticipado)
30 de agosto de 2019
Fechas de registro del estudio
Enviado por primera vez
1 de junio de 2019
Primero enviado que cumplió con los criterios de control de calidad
4 de junio de 2019
Publicado por primera vez (Actual)
6 de junio de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
4 de junio de 2019
Última verificación
1 de junio de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- U54CA14393009
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Because the pilot study sample is small (N=20), the likelihood of deductive disclosure of identity is high even if the shared data were de-identified.
Hence, there will be no sharing of individual level data with other researchers not originally comprising the investigative team.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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