跳至主要内容
临床试验/NCT04072757
NCT04072757已完成不适用

Fruit and Vegetable Prescription Program

BETH COMERFORD1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2017年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
1
主要终点
Change in Diet quality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

Intervention Group

Active Comparator

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.

干预措施: Intervention Group (Behavioral)

Control Group

Placebo Comparator

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.

干预措施: Control Group (Behavioral)

结局指标

主要结局

Change in Diet quality

时间窗: 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.

次要结局

  • Change in Household meal practices(Up to 3 Months)
  • Change in Body Mass Index (BMI)(Up to 3 Months)
  • Change in Body Composition- Body Fat and Body Water Percentage(Up to 3 Months)
  • Change in Waist circumference(Up to 3 Months)
  • Change in Serum Lipids and HbA1c(Up to 3 Months)
  • Change in Blood Pressure(Up to 3 Months)
  • Change in Purchasing Behavior(Up to 3 Months)

研究者

发起方
BETH COMERFORD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

BETH COMERFORD

PRINCIPAL INVESTIGATOR

Griffin Hospital

研究点 (1)

Loading locations...

相似试验