Griffin Hospital
Derby, Connecticut, 06418, United States
NCT Number: NCT04072757
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.
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Interventional
Not applicable
Derby, Connecticut, 06418, United States
Hypotheses
Specific Aims
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Session One: Loving Food That Loves You Back - Food as Fuel
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 Months
Body mass index (BMI) will be calculated as weight (kg) divided by height in meters (m) squared.
Time frame: 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%.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 Months
Participants will complete a brief survey (pre and post intervention) regarding their cooking practices and meal preparation.
Time frame: One week
Compliance will be tracked by attendance at the weekly workshops and redemption of coupon/vouchers.
Time frame: Up to 3 Months
Body composition (Body Weight) will be measured using the Tanita SC-240 Body Composition Analyzer.
BETH COMERFORD
Other
Acronym: FVRx
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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