Nutrition Education Program for Type 2 Diabetes and Colorectal Cancer

Overseen By Talegria Brown, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Charles Drew University of Medicine and Science

Disqualifiers: Colorectal cancer, Colectomy, Colonic polyps, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special education program can help people with Type 2 diabetes learn more about preventing colorectal cancer, improve their diets, and increase screening frequency. Participants will either receive this tailored education, which includes eight sessions and a workbook, or continue with their usual care. The study seeks to understand what encourages people with diabetes to get screened for colorectal cancer and whether this education can make a difference. Individuals with Type 2 diabetes who are African American or Hispanic and visit a participating clinic might be suitable for this trial. As an unphased study, this trial offers a unique opportunity to contribute to important research that could enhance health education and screening practices for people with diabetes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on education about nutrition and colorectal cancer prevention, so it's unlikely that medication changes are required.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on education about nutrition and colorectal cancer prevention, so it's unlikely that medication changes are required.

What prior data suggests that this education program is safe for participants?

This study involves an educational program focused on preventing colorectal cancer and promoting healthy eating for individuals with Type 2 diabetes. It does not involve drugs or medical procedures, eliminating safety risks or side effects typically associated with medications.

The program consists of eight educational sessions and a booklet designed to teach participants about cancer prevention and healthy eating. As a learning program, it is safe for all participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing Type 2 Diabetes and Colorectal Cancer through education rather than medication. Unlike standard treatments such as insulin therapy or chemotherapy, this program offers a personalized, culturally sensitive education plan. Participants receive eight sessions covering nutrition and colorectal cancer, with supportive materials to reinforce learning. This could empower patients to manage their health proactively, potentially improving outcomes and quality of life.

What evidence suggests that this education program is effective for increasing colorectal cancer knowledge and screenings in patients with Type 2 diabetes?

This trial will compare a personalized nutrition education program to usual care. Research has shown that such a program can improve dietary habits in people with colorectal cancer, increasing calorie and protein intake, which benefits their health. Studies have also found that these programs can boost colorectal cancer screening rates, particularly among individuals with type 2 diabetes. This is crucial because diabetes can raise the risk of colorectal cancer by 47%. The program aims to increase awareness of this risk and promote healthier eating habits. ^{1 2 3 4 5}

Who Is on the Research Team?

Lucy Kibe, DrPH

Principal Investigator

Charles Drew University of Medicine and Science

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 35 and 44 years old.

I have been diagnosed with type 2 diabetes.

You are African American, whether you are Hispanic or not.

Exclusion Criteria

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

Participating in another diet program

I have had colorectal cancer in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education Program

Participants receive a customized patient-centered, culturally appropriate education program, including eight education sessions and a workbook on colorectal cancer and nutrition.

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in colorectal cancer knowledge, perceptions, and dietary indices immediately and 6 months post-intervention.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Intervention Group (IG)

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group (IG) Experimental Treatment 1 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 Control 1 Intervention

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

Who Is Running the Clinical Trial?

Charles Drew University of Medicine and Science

Lead Sponsor

Trials

54

Recruited

8,500+

Published Research Related to This Trial

In a study of 106 colorectal cancer patients, low levels of albumin and reduced physical activity were found to significantly increase the length of hospital stays after surgery, with a median stay of 10 days.

Other factors like anemia, obesity, and lifestyle choices such as fruit and vegetable intake, smoking, and drinking did not significantly affect hospital stay length, highlighting the importance of managing albumin levels and encouraging physical activity for better recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of albumin and physical activity on postoperative recovery in patients with colorectal cancer: An observational study. Yang, SP., Wang, TJ., Huang, CC., et al.[2021]

In a study of 75,219 Norwegian men and women over 12 years, higher levels of leisure-time physical activity were linked to a reduced risk of colorectal cancer in men, suggesting that being active may help lower cancer risk.

Conversely, women with a history of diabetes and elevated blood glucose levels showed an increased risk of colorectal cancer, indicating that insulin resistance may play a role in promoting this type of cancer in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study of colorectal cancer risk and physical activity, diabetes, blood glucose and BMI: exploring the hyperinsulinaemia hypothesis. Nilsen, TI., Vatten, LJ.[2022]

A study involving 46,210 men and 74,191 women over 26 years found that higher dietary insulinemic potential, measured by the empirical dietary index for hyperinsulinemia (EDIH), is associated with a significantly increased risk of colorectal cancer, with a 33% higher risk in men and 22% in women for those in the highest EDIH quintile.

The increased risk was particularly notable for distal colon and rectal cancers in men, and for proximal and distal colon cancers in women, suggesting that dietary factors influencing insulin response may play a role in colorectal cancer development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of dietary insulinemic potential and colorectal cancer risk in men and women. Tabung, FK., Wang, W., Fung, TT., et al.[2023]

A study involving 2079 participants showed that a low-fat, high-fiber diet did not significantly reduce the risk of recurrent colorectal adenomas compared to a standard diet over approximately four years.

Both the intervention and control groups had similar rates of recurrent adenomas, indicating that dietary changes may not be effective in preventing the recurrence of these precursors to colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of effect of a low-fat, high-fiber diet on the recurrence of colorectal adenomas. Polyp Prevention Trial Study Group. Schatzkin, A., Lanza, E., Corle, D., et al.[2017]

A study of 74 colorectal cancer patients revealed that most followed a diet low in carbohydrates and high in protein and fat, leading to several micronutrient deficiencies.

Factors such as male gender, overweight/obesity, smoking, and low educational level were linked to poor dietary quality, indicating that targeted nutritional education could significantly improve health outcomes for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Adequacy and Diet Quality in Colorectal Cancer Patients Postsurgery: A Pilot Study. Alegria-Lertxundi, I., Alvarez, M., Rocandio, AM., et al.[2017]

In a study of 1,844 adults aged 40-74 in a rural area of China, those with a family history of colorectal cancer (CRC) consumed significantly fewer servings of plant-based foods, which may increase their risk of CRC.

Men showed multiple risk factors for lower plant-based food consumption, including family history of CRC, smoking, and alcohol use, while for women, only income was a significant factor, highlighting gender disparities in dietary habits related to CRC risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gender disparities in dietary status and its risk factors in underserved populations. Cai, SR., Zhu, HH., Li, QR., et al.[2012]

A study involving 372 prediabetic veterans showed that those who participated in nutrition education were 29% less likely to develop diabetes compared to those who did not receive this education, indicating its effectiveness in diabetes prevention.

The positive impact of nutrition education on preventing diabetes remained significant even after accounting for factors like body mass index and weight change, highlighting its potential as a key intervention in managing prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of US Veterans Nutrition Education for Diabetes Prevention. Erickson, M., Braun, K., List, R., et al.[2019]

Colorectal cancer patients who received structured in- and outpatient oncology nurse and nutritional counseling showed significant improvements in discharge management across seven areas, enhancing their overall care experience.

Patients in the intervention group reported better coping with treatment side effects and received more nutritional information, leading to improved management of food intolerances and adherence to dietary advice compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health services research in colorectal cancer: a quasi-experimental interventional pilot study on in- and outpatient oncology. Reiter, M., Gerken, M., Lindberg-Scharf, P., et al.[2021]

In a study of 191,004 participants over 8 years, higher glycemic load (GL) diets were associated with a reduced risk of colorectal cancer in women, suggesting a protective effect, particularly from white rice, which was a major contributor to GL.

Conversely, the same protective association was not observed in men, where higher GL was linked to an increased risk in white men, indicating that the relationship between diet and colorectal cancer risk may vary by sex and ethnicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of glycemic load and carbohydrate intake with colorectal cancer risk in the Multiethnic Cohort Study. Howarth, NC., Murphy, SP., Wilkens, LR., et al.[2023]

A 1-week nutritional education program for 83 diabetic patients led to significant long-term changes in dietary habits, with type 1 patients reducing caloric, protein, and fat intake, while type 2 patients showed varied results in carbohydrate and fat consumption.

Two years post-education, 45% of the patients adhered to the European Association Study for Diabetes (EASD) nutritional recommendations, indicating the program's effectiveness in promoting healthier eating behaviors among diabetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a psycho-educational nutritional program in diabetic patients. Schalch, A., Ybarra, J., Adler, D., et al.[2022]

Patients with colorectal cancer showed significant weight loss during treatment, but their muscle mass remained stable, indicating that while they may lose weight, their overall strength could be preserved.

Nutrition education provided by clinical dietitians led to improved dietary habits among patients, with increased consumption of diverse food groups, suggesting that ongoing nutritional support can enhance nutritional status and potentially aid in disease prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Continuous Nutrition Care on Nutritional Status and Dietary Habits of Patients With Colorectal Cancer Receiving Adjuvant Chemotherapy After Surgery. Son, J., Kang, HI., Jung, EY., et al.[2023]

Patients with type 2 diabetes and obesity have a higher risk of developing colorectal carcinoma, but treatment with metformin may reduce this risk, leading to its potential use in prediabetic patients as well.

Preventive measures such as regular physical activity, a healthy diet rich in fruits and vegetables, and colonoscopy are crucial for at-risk groups, particularly those with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Colorectal cancer and diabetes]. Svacina, S.[2013]

Many physicians feel unprepared to provide nutrition counseling due to inadequate training in nutrition science, which is reflected in surveys showing that most U.S. medical schools do not offer sufficient nutrition education.

The Nutrition in Medicine (NIM) project is addressing this gap by providing a free, comprehensive online nutrition curriculum for medical students and a new initiative for practicing physicians, aimed at enhancing their nutrition assessment and intervention skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition in medicine: nutrition education for medical students and residents. Adams, KM., Kohlmeier, M., Powell, M., et al.[2022]

A study involving 179 patients with type 2 diabetes mellitus (T2DM) in Padang, Indonesia, revealed that while 88.8% of patients expressed a need for individual nutrition education, many did not attend due to a lack of recommendations from doctors and personal reluctance.

Despite attending nutrition education sessions, most patients (76.5%) did not see improvements in their blood glucose control, indicating a need for better educational tools and resources, such as booklets, to enhance understanding and management of diabetes nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Individual Nutrition Education Needs among Patients with Type 2 Diabetes at the Public Health Centers in Padang, Indonesia: A Cross-Sectional Study. Puri, IY., Yusof, BM., Zaid, ZA., et al.[2022]

A culturally tailored nutrition education program for Korean American immigrants with type 2 diabetes significantly improved their diabetes-specific nutrition knowledge, as evidenced by a high satisfaction score of 9.7 out of 10.

The program effectively integrated dietary guidelines from both the American Diabetes Association and the Korean Diabetes Association, using culturally relevant materials to enhance understanding and meal planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating current dietary guidelines into a culturally tailored nutrition education program for Korean American immigrants with type 2 diabetes. Song, HJ., Han, HR., Lee, JE., et al.[2022]

An individualized nutritional education program significantly improved calorie and protein intake in colorectal cancer patients undergoing palliative chemotherapy, with p-values of 0.038 and 0.001, respectively.

The program also positively affected the nutritional status, as indicated by a significant change in serum albumin levels (p=0.040), although body weight remained stable in both the experimental and control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of individualized nutritional education programs on the level of nutrient intake and nutritional status of colorectal cancer patients undergoing palliative chemotherapy]. Park, KO., Choi-Kwon, S.[2013]

Citations

1. withpower.com withpower.com/trial/phase-colorectal-neoplasms-4-2023-daa93

Nutrition Education Program for Type 2 Diabetes and ... An individualized nutritional education program significantly improved calorie and protein intake in colorectal cancer patients undergoing palliative ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05765214/impact-of-colorectal-cancer-and-nutrition-education-program-among-minority-patients-with-type-2-diabetes?state=CA&city=Watts

Impact of Colorectal Cancer and Nutrition Education ... A major anticipated outcome is increasing the rate of colorectal cancer screening among diabetic patients at KCHC. Another outcome is improving ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10326129/

A study on the effect of nutrition education based ... In this study, we improved the outcome of postoperative ONS nutrition therapy in colorectal cancer patients by implementing a nutrition ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811815

Type 2 Diabetes and Colorectal Cancer Risk | Oncology In this cohort study of 54 597 adults, a diabetes diagnosis was associated with a 47% increased risk of developing CRC compared with participants without a ...

5. careacross.com careacross.com/clinical-trials/trial/NCT05765214

Impact of Colorectal Cancer and Nutrition Education ... This proposal will assess the impact of a colorectal cancer and nutrition education program among minority patients with type 2 diabetes by carrying out three ...