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Nutrition Education Program for Type 2 Diabetes and Colorectal Cancer

N/A

Recruiting

Led By Lucy Kibe, DrPH

Research Sponsored by Charles Drew University of Medicine and Science

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diabetes type 2 diagnosis

Age 35-75

Must not have

History of radiation treatment for another cancer (abdominal prostate, skin etc)

Cognitive impairment or inability to comprehend or provide consent to participate in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately and 6-months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial observes the impact of a tailored education program on colorectal cancer screening & dietary habits in minority patients w/ type 2 diabetes.

Who is the study for?

This trial is for minority individuals aged 35-75 with Type 2 diabetes, who have visited KCHC in the past two years and can provide contact information. It's not for those with certain digestive diseases, a history of colorectal cancer or related treatments, cognitive impairments, or those already in another diet program.

What is being tested?

The study tests if a culturally tailored education program on colorectal cancer prevention and nutrition can increase knowledge and screening rates among minorities with Type 2 diabetes. Participants will attend eight sessions and use an educational booklet.

What are the potential side effects?

Since this is an educational intervention rather than a medical treatment, there are no direct side effects like you'd expect from medication. However, changes in diet as recommended by the program may lead to temporary digestive adjustments.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with type 2 diabetes.

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I am between 35 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation treatment for a different cancer before.

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I am able to understand and agree to participate in the study.

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I have had colorectal cancer in the past.

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I have had surgery to remove part or all of my colon.

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I have a history of colon polyps.

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I have a history of Crohn's disease.

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I have ulcerative colitis.

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My doctor expects I have less than 10 years to live.

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I have cystic fibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately and 6-months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately and 6-months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately and 6-months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CRC-KPSS change and screening uptake

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Group (IG)Experimental Treatment1 Intervention

Participants randomized to the IG will receive a customized patient-centered, culturally appropriate education program. Patients randomized to the IG will participate in eight (8) education sessions. A booklet with colorectal cancer education and nutrition education will be developed and print materials given to the participants to use as a workbook.

Group II: Usual Care (UC)Active Control1 Intervention

Patients randomized to UC group will continue to receive care at the clinic without any intervention from the study team.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intervention Group (IG)

2015

N/A

~3410

0 / 11Eligibility criteria met