In this randomized control study, participants will be randomized 1:1 to either participate in the YMCA's Produce Prescription Program (YPRx) and receive weekly deliveries of fresh produce bags for their household or to receive YPRx plus participate in the Diabetes Prevention Program (DPP). The investigators hypothesize that participants randomized to receive YPRx plus DPP will have greater weight loss, increased physical activity, improved diet quality and behaviors, increased food security, improved self-rated health assessment, decreased healthcare utilization from baseline to endline (12 months) compared to those randomized to receive YPRx produce deliveries only. We will also collect data on process measures for implementation purposes.
This study is a randomized control trial testing the impact of adding disease-specific, evidence-based health education (DPP) to produce prescriptions (YPRx) on participants' health. DPP is a 12-month diabetes prevention behavioral weight loss program developed by the Centers for Disease Control and Prevention and implemented nationwide. In this study, investigators will test whether the addition of health education, coaching, and peer support through DPP improves the effectiveness of YPRx. This trial will take place in the Washington D.C. Metropolitan Area in collaboration with the YMCA of Metropolitan Washington, a provider of DPP and YPRx, Hungry Harvest, a purveyor of produce deliveries, and Amerigroup/Elevance Health, a Medicaid managed care organization. Participants will be randomized 1:1 to either participate in YPRx only or to participate in YPRx plus the DPP. The length of the trial will be 12 months for each participant, and outcomes will be measured at baseline, 4 weeks, 3 months, 6 months, 9 months, and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Participants in the control group will receive weekly, home-delivered produce bags of fresh vegetables and fruits and sized for each participants' household. Produce deliveries will be administered for 52 weeks.
Participants will receive weekly, home-delivered produce bags of fresh vegetables and fruits and sized for each participants' household. Produce deliveries will be administered for 52 weeks. Additionally, participants will be registered for a free, year-long YMCA membership and enrolled in the DPP. Through the DPP, participants will receive health education, coaching, and peer support via 26 virtual group sessions over a year.
YMCA of Metropolitan Washington
Washington D.C., District of Columbia, United States
Change in body weight
Change in body weight will be measured by change in absolute pounds and percent of body weight. Participants will provide self-reported weight in pounds via quarterly online surveys at baseline, 3 months, 6 months, 9 months, and 12 months (endline).
Time frame: Baseline, 3 months, 6, months, 9 months, and 12 months
Change in physical activity
Change in physical activity will be measured by the change in absolute minutes of physical activity and percent change in time spent being physically active. Minutes spent being physically active over the past 7 days, self-reported via quarterly online surveys at baseline, 3 months, 6 months, 9 months, and 12 months (endline).
Time frame: Baseline, 3 months, 6, months, 9 months, and 12 months
Change in food security status
Change in food insecurity will be measured using the 6-question U.S. Household Food Security Screener Module which ask participants about food security within the household framed around personal and familial food consumption based on the ability to afford food in the past 30 days. Responses will be self-reported via online surveys at baseline and endline (12 months).
Time frame: Baseline and 12 months
Change in participant dietary intake
Change in dietary intake will be measured using the National Cancer Institute's Dietary Screener Questionnaire. Frequency of food and beverage consumption over the previous month will be self-reported by participants via online surveys at baseline and endline (12 months). Foods and beverages include: "Pure Fruit Juices", "Fruit", "Green Leafy or Lettuce Salad", "Fried Potatoes", "Other Kinds of Potatoes", "Cooked Beans", "Vegetables", "Salsa", "Pizza", and "Tomato Sauce". Responses to all questions will be measured using 11-point scale ranging from "Never" to "6 or more times per day" for "Pure Fruit Juices", a 9-point scale ranging from "Never" to "2 or more times per day" for all other food categories, plus an additional response option "Don't know/Prefer not to answer" for each question.
Time frame: Baseline and 12 months
Change in participant food behaviors
Change in food behavior will be measured as the change in number of days (0-7) the participant, or someone else in their family, cooked dinner at home during the preceding week. Frequencies will be self-reported by participants via online surveys at baseline and endline (12 months).
Time frame: Baseline and 12 months
Change in personal health self-rated health assessment
Change in self-rated health assessment will be measured by the change in participant's self-rated health assessment collected via online survey at baseline and 12 months using a five-point Likert scale ("Poor" to "Excellent") .
Time frame: Baseline and 12 months
Change in participant healthcare utilization- self-reported
Change in healthcare utilization will be measured by the change in frequency of accessing healthcare during the three months preceding baseline and endline. This outcome will be measured by whether or not the participant accessed various types of medical attention ("Yes", "No" "Don't know/Prefer not to answer"), and if so, how many times ("None" to "16 or more" plus "Don't know/Prefer not to answer") as self-reported via online surveys at baseline and endline (12 months).
Time frame: Baseline and 12 months
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