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Fruit and Vegetable Prescription Program (FVRx)

26 de marzo de 2020 actualizado por: BETH COMERFORD
The purpose of this study is to determine the effectiveness of a worksite based Fruit & Vegetable Prescription (Rx) Program designed to increase fruit and vegetable consumption and improve diet quality and other health outcomes of participants. The program includes incentives (coupons) and skill building/educational sessions to increase intake of fruits, vegetables, and other health promoting foods (i.e. legumes, whole grains). The program will focus on delicious, nutritious, affordable, simple and quick meal preparation.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Hypotheses

  • The program will increase intake of fruits, vegetables and other health promoting foods, and will improve diet quality.
  • The program will improve household meal practices.
  • The program will improve BMI, waist circumference, lipid panel, HbA1c, and blood pressure.
  • Improvements in outcome measures will be sustained 3 months post intervention.

Specific Aims

  • To determine the effect of a worksite based F&V Rx program as compared to control/no intervention on diet quality.
  • To determine the effects of a worksite based F&V Rx program as compared to control/no intervention on household meal practices.
  • To determine the effects of a worksite based F&V Rx program as compared to control/no intervention on BMI, waist circumference, lipid panel, HbA1c, and blood pressure.
  • To determine whether improvements resulting from the program are sustainable over time.

Background In 2011-2012, two-thirds of adults and over 30% of children and adolescents in the U.S. were overweight or obese. Obesity is widely recognized as a grave public health concern because of its association with increased risk for a multitude of chronic diseases and other adverse health outcomes. The persistence of high obesity rates in children and adults in the U.S. and the low rates of adherence to current recommendations for fruit and vegetable consumption are evidence of the inadequacy of efforts to date to promote healthy lifestyles.

Adults-specifically, parents-have a strong influence on children's eating and physical activity habits. Children have innate preferences for sweet, energy-dense foods; however, some food preferences are learned. Early introduction and repeated exposure to healthy foods may help to familiarize and increase acceptance and liking of those foods. Parents can help children learn healthy eating habits by using appropriate child feeding practices, modeling the desired behaviors, and creating a home food environment that is conducive to healthy eating. Likewise, parents' physical activity behaviors may also influence children's activity levels. To achieve meaningful change in childhood obesity, it is necessary to change the culture of the entire household by reaching both adults and children.

Whereas children are often exposed to health promotion programming in schools, adults may be exposed to similar messages at work. There is an extensive literature on the capacity of worksites to effectively promote healthy lifestyles while reducing medical costs and absenteeism. Worksite interventions targeting fruit and vegetable consumption have been found to be effective, particularly when they include a focus on employees' families. Interventions that include a subsidy or financial incentive to reduce the cost of fruits, vegetables, and other healthy foods have also been shown to increase the purchase and consumption of those foods. However, there are few if any studies evaluating the effectiveness of a worksite-based intervention including financial incentives for fruit and vegetable purchases, nutrition education, and a focus on changing the behavior of the whole family.

Tipo de estudio

Intervencionista

Inscripción (Actual)

58

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

    • Connecticut
      • Derby, Connecticut, Estados Unidos, 06418
        • Griffin Hospital

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Griffin employees, aged 18 and over, with a child/children enrolled in VITAHLS schools (Shelton, Ansonia, Derby, Seymour, and Naugatuck) - grades pre-k thru 12.
  2. be able to attend weekly 45 minutes nutrition/cooking workshops.

Exclusion Criteria:

  1. Inability to attend majority of the Nutrition and cooking workshops
  2. Anticipated inability to complete study protocol for any reason
  3. Diagnosis of cancer except skin cancer of less than 5 years or unstable treatment for less than 5 years.
  4. Unstable angina or other significant cardiovascular condition, prior or planned bariatric surgery.

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: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Intervention Group
The cooking skill building/nutrition education workshops will be led by a multidisciplinary team comprised of: a chef/instructor, a nutritionist and/or registered dietitian, MD and/or Preventive Medicine Resident, and Yale-Griffin Prevention Research Center staff. The cooking/nutrition education workshop sessions will be approximately 45 minutes and will: include a plant forward approach to healthy eating; integrate nutrition and health-related information and cooking instruction (i.e. knife skills, equipment use); show participants how to prepare meals that are simple, nutritious, affordable, and delicious; provide recipes and nutrition information aimed at improving dietary intake and health status; and provide an enjoyable program that participants will look forward to attending. Fruit and vegetable prescription vouchers will be redeemed at ShopRite grocery stores (Ansonia and Shelton locations) and Griffin Hospital's farmers market, where redemption will be tracked.

Session One: Loving Food That Loves You Back - Food as Fuel

  • connection nutrition and health Session Two: Myth busting: Fruits and Vegetables - delicious and affordable
  • seasonal fruits & vegetables in the diet Session Three: No Time to Cook! Making nutritious meals that are fast and easy
  • quickly make delicious/nutritious meals using minimal ingredients Session Four: Don't Eat Food You Can't Pronounce Except Quinoa; Eat Quinoa
  • choose healthier foods Session Five: Taste Bud Rehab
  • reduce foods high in sugar and salt.Mind-body connection Session Six: Batch & One Ingredient Cooking
  • making large quantities to freeze; one ingredient cooking Session Seven: Sweet Tooth? Healthy Desserts
  • prepare healthier desserts Session Eight: Family Meal Practices
  • healthy eating habits in children Session Nine: Snacks as Mini Meals
  • make nutritious snacks to keep energy up all day Session Ten: Revamp Your Favorite Recipe
  • "healthy up" favorite recipes
Comparador de placebos: Control Group
The control group will not receive vouchers or nutrition education/skill building but will be exposed to any standard Griffin Hospital worksite offerings. A "mini program" (2 -4 hours) workshop will be offered to participants in the control group, and all intervention materials will be provided.
The control group will not receive vouchers or nutrition education/skill building but will be exposed to any standard Griffin Hospital worksite offerings. A "mini program" (2 -4 hours) workshop will be offered to participants in the control group, and all intervention materials will be provided.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Diet quality
Periodo de tiempo: Up to 3 Months
Participants will complete three 24-hour recalls using the web-based ASA24 - http://riskfactor.cancer.gov/tools/instruments/asa24/ (Automated Self-Administered 24-Hour Recall) at each of the 3 assessment time points (9 total). Diet quality will be assessed using the Healthy Eating Index 2010. The Prevention Research Center will have computers available for participants who do not have access to computers to complete the ASA24.
Up to 3 Months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Household meal practices
Periodo de tiempo: Up to 3 Months
The Meals in Our Household questionnaire will be used to assess changes in household meal practices (e.g. preparation, timing and location of meals; child behavior during meals, etc.). Because this instrument was designed for families with children between the ages of 3 and 11, it will only be administered to participants with children within this age range.
Up to 3 Months
Change in Body Mass Index (BMI)
Periodo de tiempo: Up to 3 Months
Body mass index (BMI) will be calculated as weight (kg) divided by height in meters (m) squared.
Up to 3 Months
Change in Body Composition- Body Fat and Body Water Percentage
Periodo de tiempo: Up to 3 Months
Body composition (Body Fat and Body Water Percentage) will be measured using bioelectrical impedance analysis, which uses the resistance of electrical flow through the body to estimate body fat and water. The Tanita SC-240 Body Composition Analyzer will be used to measure body composition. The SC-240 calculates body fat% and total body water%.
Up to 3 Months
Change in Waist circumference
Periodo de tiempo: Up to 3 Months
Waist circumference will be measured using the U.S. government standard protocol. To measure the waist circumference, the clinical research coordinator will ask the participant to stand and he/she will place a tape measure around the participant's middle, just above her/his hipbones, at the level of the belly button. The clinical research coordinator will ensure that the tape is horizontal around the participant's waist, and will then keep the tape snug around the participant's waist while not compressing the skin, and will measure her/his waist just after exhaling.
Up to 3 Months
Change in Serum Lipids and HbA1c
Periodo de tiempo: Up to 3 Months
Total cholesterol (Tchol), triglycerides (TG), and high-density lipoprotein (HDL) will be obtained by direct measurements. Very-low-density lipoprotein (VLDL) and low-density-lipoprotein (LDL) will be obtained by calculation: VLDL = TG/5; and LDL = Tchol - (VLDL + HDL). HDL: Tchol ratio will be used to evaluate the impact of treatment assignments on the lipid panel. If the PRC staff see that your lab values are abnormal, we will give you a copy of your test results and ask that you follow up with your doctor for care
Up to 3 Months
Change in Blood Pressure
Periodo de tiempo: Up to 3 Months
will be measured by using a Dinamap Monitor Pro 100 (GE Healthcare, Piscataway, NJ) after sitting for 5 minutes. Both systolic and diastolic pressures will be calculated as the mean value of 2 readings 5 minutes apart for each participant at every time point of assessment. If either number of your blood pressure reading is 170/110 mmHg or above, the Prevention Research Center staff will plan to escort you to the Emergency Department for care.
Up to 3 Months
Change in Purchasing Behavior
Periodo de tiempo: Up to 3 Months
will be tracked using the NutriSavings (www.nutrasavings.com) system which is offered to all Griffin employees. If not currently enrolled in Nutrasavings, employees will be enrolled as part of the study enrollment processes.
Up to 3 Months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Physical Activity
Periodo de tiempo: Up to 3 Months
Physical activity will be assessed using the International Physical Activity Questionnaire [15] Short Form to allow us to control for changes in PA that could affect outcome measures. The IPAQ is a valid and reliable tool to assess physical activity in adults. It is a more comprehensive tool containing information on weekly activities in household and yard-work activities, occupational activity, transport, leisure time physical activity and sedentary behavior.
Up to 3 Months
Change in Cooking Skills
Periodo de tiempo: Up to 3 Months
Participants will complete a brief survey (pre and post intervention) regarding their cooking practices and meal preparation.
Up to 3 Months
Compliance
Periodo de tiempo: One week
Compliance will be tracked by attendance at the weekly workshops and redemption of coupon/vouchers.
One week
Change in Body Composition- Body Weight
Periodo de tiempo: Up to 3 Months
Body composition (Body Weight) will be measured using the Tanita SC-240 Body Composition Analyzer.
Up to 3 Months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Beth P Comerford, MS, Yale-Griffin Prevention Research Center
  • Silla de estudio: Kimberly Doughty, PhD, MPH, Yale-Griffin Prevention Research Center

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

Enlaces Útiles

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)

20 de abril de 2017

Finalización primaria (Actual)

31 de enero de 2019

Finalización del estudio (Actual)

31 de enero de 2019

Fechas de registro del estudio

Enviado por primera vez

1 de noviembre de 2017

Primero enviado que cumplió con los criterios de control de calidad

26 de agosto de 2019

Publicado por primera vez (Actual)

28 de agosto de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de marzo de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

26 de marzo de 2020

Última verificación

1 de marzo de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2017-02

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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

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. .

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