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Food support for Type 2 Diabetes (NU-DSMP Trial)

N/A
Recruiting
Led By Kartika Palar, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up twelve weeks and twenty-four weeks
Awards & highlights

NU-DSMP Trial Summary

This trial will test if providing food support and case-management to people with type 2 diabetes who are enrolled in Medicaid will help improve their glycemic control and other outcomes.

Eligible Conditions
  • Type 2 Diabetes

NU-DSMP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and twelve weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and twelve weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hemoglobin A1c (HbA1c) from baseline to twelve weeks by study arm
Change in food security severity from baseline to twelve weeks by study arm
Secondary outcome measures
Change in consumption of added sugars from baseline to twelve weeks by study arm
Change in consumption of fruits and vegetables from baseline to twelve weeks by study arm
Change in depressive symptoms from baseline to twelve weeks by study arm
+4 more
Other outcome measures
Change in HbA1c values from twelve weeks to twenty-four weeks by study arm
Change in health-related quality of life (healthy days) from twelve weeks to twenty-four weeks by study arm
Change in the proportion of participants with glycemic control from twelve weeks to twenty-four by study arm

NU-DSMP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Diabetes-tailored food support plus diabetes self-management educationExperimental Treatment2 Interventions
The intervention has two components: 1) diabetes-tailored food support that consists of weekly, home-delivered medically tailored meals, and monthly home-delivered healthy groceries, from baseline to 24 weeks, and 2) three case-management sessions with client services staff from the partnering nutrition agency over the 12 weeks of intervention. The intervention will be delivered in addition to a base condition consisting of remote participation in the Diabetes Self-Management Program, an evidence-based diabetes education program that takes place over 6 weeks also received by the control group as part of the standard of care.
Group II: Standard of care including diabetes self-management educationActive Control1 Intervention
Control participants will receive standard of care as offered by clinical partners to all T2DM patients, including referral to nutritional counseling, T2DM support groups, and participation in local diabetes self-management programs. Control participants are also often provided referral information for locally available food support services in the region that provide diabetes-appropriate foods. Control participants will participate in the Diabetes Self-Management Program, an evidence-based program that takes place over 6 weeks that meets the standard of care for diabetes education. At the end of follow up, the control arm will receive three months diabetes-tailored food support consisting of diabetes-tailored grocery boxes and nutrition case-management.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,114 Total Patients Enrolled
Project Open HandOTHER
3 Previous Clinical Trials
823 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,503 Previous Clinical Trials
15,236,583 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being enrolled for this clinical exploration presently?

"The data posted on clinicaltrials.gov is indicative of this trial's requirement for participants; it was first published in November 2021 and recently updated in October 2022."

Answered by AI

How many participants may enroll in this experiment?

"Indeed, the information on clinicaltrials.gov reveals that this medical trial is actively recruiting participants and has been since November 8th 2021. The study was last revised on October 14th 2022 and requires 72 patients to be recruited from a single location."

Answered by AI

What are the fundamental goals of this clinical experiment?

"This medical trial's primary end-point, evaluated over the course of twelve weeks from Baseline, is a variation in Hemoglobin A1c (HbA1c). Secondary outcomes include alteration in participants that have achieved glucose control defined by HbA1c levels being below 9%, adjustment to depressive symptoms gauged with PHQ-8 scores ranging from 0 to 24, and changes in those experiencing low or very low food security ascertained through 3 affirmative answers on the USDA US Household Food Security Survey Module."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Pilot Trial of the Nutrition-Supported Diabetes Education Program
2021. "Pilot Trial of the Nutrition-Supported Diabetes Education Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05067452.
~21 spots leftby Apr 2025
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