Clinical trial NCT04072757: Fruit and Vegetable Prescription Program
Official title: Fruit and Vegetable Prescription Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Griffin Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Diet quality
timeFrame: Up to 3 Months
Secondary outcomes:
measure: Change in Household meal practices
timeFrame: Up to 3 Months
measure: Change in Body Mass Index (BMI)
timeFrame: Up to 3 Months
measure: Change in Body Composition- Body Fat and Body Water Percentage
timeFrame: Up to 3 Months
measure: Change in Waist circumference
timeFrame: Up to 3 Months
measure: Change in Serum Lipids and HbA1c
timeFrame: Up to 3 Months
measure: Change in Blood Pressure
timeFrame: Up to 3 Months
measure: Change in Purchasing Behavior
timeFrame: Up to 3 Months
Other outcomes:
measure: Change in Physical Activity
timeFrame: Up to 3 Months
measure: Change in Cooking Skills
timeFrame: Up to 3 Months
measure: Compliance
timeFrame: One week
measure: Change in Body Composition- Body Weight
timeFrame: Up to 3 Months
Locations:
city: Derby
country: United States
facility: Griffin Hospital
state: Connecticut
Study officials:
affiliation: Yale-Griffin Prevention Research Center
name: Beth P Comerford, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale-Griffin Prevention Research Center
name: Kimberly Doughty, PhD, MPH
role: STUDY_CHAIR
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