Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561412
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Penn Produce Prescription and Chronic Kidney Disease Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Randomized Trial of a Produce Prescription Intervention to Improve Health Among Food Insecure Adults With Chronic Kidney Disease
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this pilot clinical trial is to examine the feasibility acceptability and likely effect of a produce prescription intervention on patient-centered outcomes health behaviors and health outcomes among food insecure adults with chronic kidney disease stages 3 - 5
Participants will complete surveys at three timepoints each three months apart and complete health measurements at two timepoints 6 months apart Half of the participants will be randomly assigned to the treatment where they will receive produce prescriptions with amount of the vouchers depending on their reported family size every two weeks over six months Researchers will compare the treatment group and the control group to see if there are any improvements in patient-centered outcomes food and nutrition insecurity health-related quality of life depression and anxiety and clinical outcomes diet quality metabolic acidosis serum albumin estimated GFR blood pressure and HbA1C
Participants will complete surveys at three timepoints each three months apart and complete health measurements at two timepoints 6 months apart Half of the participants will be randomly assigned to the treatment where they will receive produce prescriptions with amount of the vouchers depending on their reported family size every two weeks over six months Researchers will compare the treatment group and the control group to see if there are any improvements in patient-centered outcomes food and nutrition insecurity health-related quality of life depression and anxiety and clinical outcomes diet quality metabolic acidosis serum albumin estimated GFR blood pressure and HbA1C
Detailed Description:
The study team will conduct a two-arm 11 randomized controlled trial to examine the feasibility acceptability and likely effect of a produce prescription intervention on patient-centered outcomes health behaviors and health outcomes among food insecure adults with CKD stages 3-5 The studys specific aims are
Aim 1 Establish a community advisory board CAB to inform and guide the produce prescription intervention The CAB will include patients community members CKD providers and relevant community partners
Aim 2 Evaluate the effectiveness of a produce prescription intervention on clinical and patient centered outcomes in a randomized trial among n100 people with CKD and food insecurity People with CKD stages 3-5 and food insecurity will be randomized to either a control or intervention group which will receive a twice monthly produce prescription voucher to purchase fruits and vegetables at local stores for 6 months Participants will be followed for patient-centered outcomes food and nutrition insecurity health-related quality of life depression and anxiety and clinical outcomes diet quality metabolic acidosis serum albumin estimated GFR blood pressure and HbA1c The studys hypothesis is that participants receiving the intervention will have improvements in food and nutrition security diet quality and other patient-centered outcomes compared to the control group The CKD clinical outcomes are exploratory and will serve as a proof-of-concept for this type of intervention in a CKD population
Aim 3 Determine intervention acceptability and uptake and explore patient experiences with managing food insecurity and CKD Researchers will administer surveys to eligible individuals who decline study enrollment n20 monitor self-report of voucher delivery and usage and track voucher redemption rates to assess acceptability and uptake Researchers will also conduct in-depth semi-structured interviews with participants in the intervention n20 and control n10 group to elucidate the experience of food insecurity and CKD co-management coping strategies and perceptions of the intervention
Aim 1 Establish a community advisory board CAB to inform and guide the produce prescription intervention The CAB will include patients community members CKD providers and relevant community partners
Aim 2 Evaluate the effectiveness of a produce prescription intervention on clinical and patient centered outcomes in a randomized trial among n100 people with CKD and food insecurity People with CKD stages 3-5 and food insecurity will be randomized to either a control or intervention group which will receive a twice monthly produce prescription voucher to purchase fruits and vegetables at local stores for 6 months Participants will be followed for patient-centered outcomes food and nutrition insecurity health-related quality of life depression and anxiety and clinical outcomes diet quality metabolic acidosis serum albumin estimated GFR blood pressure and HbA1c The studys hypothesis is that participants receiving the intervention will have improvements in food and nutrition security diet quality and other patient-centered outcomes compared to the control group The CKD clinical outcomes are exploratory and will serve as a proof-of-concept for this type of intervention in a CKD population
Aim 3 Determine intervention acceptability and uptake and explore patient experiences with managing food insecurity and CKD Researchers will administer surveys to eligible individuals who decline study enrollment n20 monitor self-report of voucher delivery and usage and track voucher redemption rates to assess acceptability and uptake Researchers will also conduct in-depth semi-structured interviews with participants in the intervention n20 and control n10 group to elucidate the experience of food insecurity and CKD co-management coping strategies and perceptions of the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None