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Nutrition Intervention for Diabetes (CHEFS-DM Trial)

Q: What is the intent of this investigation?

This trial, monitored over a period of roughly six months from Baseline, will measure the fluctuation in food insecurity severity between its two arms. As secondary objectives, changes in participants' body mass index (BMI), healthy eating index score 2015 (HEI-2015) and hospital admissions between these points are also being recorded. BMI is calculated by taking three readings of one's weight and height at both baseline and 6 months, whilst HEI-2015 measures how well dietary guidelines for Americans are adhered to when consuming meals during this time frame. Hospitalization rate amongst participants will be reported as part of this investigation too.

Q: How many individuals have been admitted to participate in this scientific experiment?

Accurately, the information available on clinicaltrials.gov confirms that this research is actively looking for participants. This study was initially posted to the website on August 23rd 2021 and its most recent update was October 14th 2022 with a goal of recruiting 440 individuals from 1 site.

Q: Is this research currently welcoming participants?

Affirmative. The details on clinicaltrials.gov indicate that this medical trial is enrolling patients at present. It was first published in August 2021 and its parameters were last modified in October 2022, with 440 volunteers required from 1 location.

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

Adequate cognitive and hearing capacity to consent and complete study measures

Screening positive for food insecurity (at least one positive answer) in the previous 6 months assessed using the 6-item version of the US Household Food Security Survey Module (US Department of Agriculture), or has household income <200% of the federal poverty level

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6 months

Awards & highlights

CHEFS-DM Trial Summary

This trial will test the impact of a six month medically tailored food support and nutrition intervention on glycemic control and other cardiometabolic outcomes.

Who is the study for?

This trial is for adults over 18 living in Alameda or San Francisco County with Type 2 Diabetes, who are food insecure or have low income. They must speak English or Spanish and be able to attend educational workshops. People can't join if they're pregnant, lactating, planning to move soon, already receiving multiple free meals daily, lack meal prep facilities, have certain health conditions affecting the study's measures or eat a diet incompatible with the provided meals.Check my eligibility

What is being tested?

The CHEFS-DM program is being tested for its effectiveness on improving blood sugar control and other heart-related health outcomes in people with Type 2 Diabetes through medically tailored food support and nutrition education over six months. The study will also evaluate how this intervention could lead to lasting health benefits and its economic impact.See study design

What are the potential side effects?

Since this trial involves nutritional counseling and food support rather than medication, there aren't typical side effects like you'd see with drugs. However, participants may experience changes in their dietary habits which could affect their overall well-being.

CHEFS-DM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and respond to study requirements.

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I have experienced food insecurity or my income is below 200% of the federal poverty level in the last 6 months.

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I have been diagnosed with type 2 diabetes based on my medical records.

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I am 18 years old or older.

CHEFS-DM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and six months 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 from baseline to six months by study arm

Change in food insecurity severity from baseline to six months by study arm

Secondary outcome measures

Acute health care utilization from baseline to six month by study arm

Body Weight Changes

Change in depressive symptoms from baseline to six months by study arm

+10 more

Other outcome measures

Durability in scores of food security from six to twelve months in the intervention arm.

Durability of HbA1c values from six months to twelve months in the intervention arm.

CHEFS-DM Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Food support and nutrition educationExperimental Treatment2 Interventions

The intervention entails two components: 1) food support that consists of weekly medically tailored meals and healthy groceries that on average covers 75% of daily energy requirements from baseline to six months and 2) diabetes-tailored nutritional education that consists of two individual counseling sessions with a Registered dietitian and four group education sessions.

Group II: Standard of careActive 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. At the end of follow up, the control arm will receive similar services from POH to what the intervention arm received during the intervention, regardless POH eligibility criteria (6 months of DM-tailored food support to meet 67% of their daily requirements, video recording of the 4 CHEFS-DM education classes, and access to a POH dietitian at their request).

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Project Open HandUNKNOWN

3 Previous Clinical Trials

455 Total Patients Enrolled

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,115 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,055 Total Patients Enrolled

Media Library

Food support Clinical Trial Eligibility Overview. Trial Name: NCT04959487 — N/A

Type 2 Diabetes Research Study Groups: Standard of care, Food support and nutrition education

Type 2 Diabetes Clinical Trial 2023: Food support Highlights & Side Effects. Trial Name: NCT04959487 — N/A

Food support 2023 Treatment Timeline for Medical Study. Trial Name: NCT04959487 — N/A

Frequently Asked Questions

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

What is the intent of this investigation?

"This trial, monitored over a period of roughly six months from Baseline, will measure the fluctuation in food insecurity severity between its two arms. As secondary objectives, changes in participants' body mass index (BMI), healthy eating index score 2015 (HEI-2015) and hospital admissions between these points are also being recorded. BMI is calculated by taking three readings of one's weight and height at both baseline and 6 months, whilst HEI-2015 measures how well dietary guidelines for Americans are adhered to when consuming meals during this time frame. Hospitalization rate amongst participants will be reported as part of this investigation too."

Answered by AI

How many individuals have been admitted to participate in this scientific experiment?

"Accurately, the information available on clinicaltrials.gov confirms that this research is actively looking for participants. This study was initially posted to the website on August 23rd 2021 and its most recent update was October 14th 2022 with a goal of recruiting 440 individuals from 1 site."

Answered by AI

Is this research currently welcoming participants?

"Affirmative. The details on clinicaltrials.gov indicate that this medical trial is enrolling patients at present. It was first published in August 2021 and its parameters were last modified in October 2022, with 440 volunteers required from 1 location."

Answered by AI