Fruit and Vegetable Prescription Program (FVRx)

BETH COMERFORD

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Intervention Group; Behavioral: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04072757

2017-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 58 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups, including a placebo group

Intervention Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Intervention Group

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Control Group