YMCA Produce Prescription Project (YPRx): Clinical Trial Identifier NCT06695104
2024 NOV 28 (NewsRx) -- By a
As a matter of record, on
Tracking Information
Trial Identifier | NCT06695104 |
First Submitted Date | |
First Posted Date | |
Results First Submitted Date | Not Provided |
Results First Posted Date | Not Provided |
Last Update Submitted Date | |
Last Update Posted Date | |
Primary Completion Date | |
Start Date | 2025-01-06 |
Current Primary Outcome Measures | •Change in body weight [ Time Frame: Baseline, 3 months, 6, months, 9 months, and 12 months ] -- 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). |
Current Secondary Outcome Measures | •Change in physical activity [ Time Frame: Baseline, 3 months, 6, months, 9 months, and 12 months ] -- 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). |
•Change in food security status [ Time Frame: Baseline and 12 months ] -- Change in food insecurity will be measured using the 6-question |
|
•Change in participant dietary intake [ Time Frame: Baseline and 12 months ] -- 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. | |
•Change in participant food behaviors [ Time Frame: Baseline and 12 months ] -- 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). | |
•Change in personal health self-rated health assessment [ Time Frame: Baseline and 12 months ] -- 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”) . | |
•Change in participant healthcare utilization- self-reported [ Time Frame: Baseline and 12 months ] -- 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). | |
Other Outcome Measures | •Change in participant healthcare utilization- healthcare records [ Time Frame: Baseline and 12 months ] -- Change in healthcare utilization will be measured by comparing healthcare claims data at baseline and endline (12 months). |
•Change in participant HbA1c [ Time Frame: Baseline and 12 months ] -- Change in participant HbA1c will be measured by the absolute change and percent change in HbA1c levels retrieved from healthcare claims data at baseline and endline (12 months). | |
•YMCA Produce Rx (YPRx) program satisfaction- quantitative process measure [ Time Frame: 4 weeks, 3 months, 6 months, 9 months, 12 months ] -- Participant satisfaction with the |
|
•YMCA Produce Rx (YPRx) program satisfaction- qualitative process measure [ Time Frame: 4 weeks, 3 months, 6 months, 9 months, 12 months ] -- Participant satisfaction with the |
|
•Self-perceived |
|
Change History | Complete list of historical revisions of study NCT06695104 |
Descriptive Information
Brief Title | |
Official Title | |
Brief Summary | 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. |
Detailed Description | 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 |
Study Type | INTERVENTIONAL |
Study Phase | NA |
Study Design | Allocation: RANDOMIZED |
Intervention Model: PARALLEL | |
Primary Purpose: PREVENTION | |
Masking: NONE | |
Intervention Model Description: Participants will be randomized into one of two study arms: intervention or control. All participants, regardless of study arm, will be enrolled in a year-long Produce Rx Program through which they will receive weekly deliveries of grocery bags containing fresh produce. Additionally, participants assigned to the intervention arm will be enrolled in a Diabetes Prevention Program, coordinated by the Y, through which they will receive health education, coaching, and peer support for a year via 26 virtual group sessions. | |
Condition | Pre-diabetes |
Intervention | •BEHAVIORAL: |
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. | |
•BEHAVIORAL: |
|
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 |
|
Study Arms | •EXPERIMENTAL: Produce Rx Program + Diabetes Prevention Program |
Interventions: | |
⚬BEHAVIORAL: |
|
•ACTIVE_COMPARATOR: Produce Rx Program Only (Control) | |
Interventions: | |
⚬BEHAVIORAL: |
Recruitment Information
Recruitment Status | NOT_YET_RECRUITING |
Enrollment | 150 |
Completion Date | 2026-06-30 |
Primary Completion Date | |
Eligibility | Inclusion Criteria: * Over the age of 18 * Recipient of Medicaid through Amerigroup * Has never been diagnosed with type I or type II diabetes * Access to laptop, computer, or phone with internet, or willing to use a provided device * |
Sex/Gender | Sexes Eligible for Study: ALL |
Ages | 18 years to |
f | |
Contacts | Primary contact: |
Backup contact: |
|
Listed Location Countries | |
Removed Location Countries |
Administrative Information
NCT Number | NCT06695104 |
Other Study ID Numbers | 2022-70424-38459 |
00022594 | |
Has Data Monitoring Committee | Not Provided |
Not Provided | |
Plan to Share Data (IPD) Description | Not Provided |
Collaborators | ⚬AmeriGroup |
⚬Hungry Harvest | |
⚬Johns Hopkins |
|
⚬Elevance Health | |
Investigators | PRINCIPAL_INVESTIGATOR: |
PRINCIPAL_INVESTIGATOR: |
|
Information Provided By | |
Verification Date | 2024-11 |
(Our reports deliver fact-based news of research and discoveries from around the world.)
New Data from Emory University Illuminate Research in Lymphoma (Medicaid Coverage Continuity is Associated with Lymphoma Stage among Children and Adolescents/Young Adults): Oncology – Lymphoma
New report projects 22% increase in car insurance costs after 15% spike in first half of 2024
Advisor News
Annuity News
Health/Employee Benefits News
Life Insurance News