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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this observation study is to deliver an education program designed to increase knowledge of colorectal cancer prevention and nutrition education in minorities with Type 2 diabetes. The main questions it aims to answer are: * What factors are associated with colorectal cancer screening among patients with type 2 diabetes? * Will implementing a customized patient-centered, culturally appropriate colorectal cancer education, and nutrition education program reduce the risk for colorectal cancer among patients with type 2 diabetes? * What is the impact of a patient-centered, culturally appropriate colorectal cancer education, and nutrition education intervention program on colorectal cancer screening and dietary indices among patients with type 2 diabetes compared to outcomes with patients who do not receive the intervention (usual care)? Participants randomized to the intervention group will: * receive a customized patient-centered, culturally appropriate education program * participate in eight (8) education sessions * be given booklet with colorectal cancer education and nutrition education to use as a workbook Researchers will compare colorectal cancer knowledge, perceptions, self-care, and social norms scores and dietary indices of the intervention group to the control group immediately and 6-months post intervention to see if the education program increased colorectal cancer knowledge and screenings and changes in dietary habits.

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 data supports the effectiveness of the treatment for colorectal cancer and nutrition education program?

Research shows that nutrition education can help colorectal cancer patients improve their eating habits, such as increasing their intake of fruits, vegetables, and proteins, which can enhance their nutritional status and potentially improve their recovery and overall health during treatment. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment for Type 2 Diabetes and Colorectal Cancer?

Research shows that nutrition education can help colorectal cancer patients improve their eating habits, which may enhance their nutritional status and potentially improve treatment outcomes. This suggests that a nutrition education program could be beneficial for managing colorectal cancer. ^{1 2 3 4 6}

Is the Nutrition Education Program for Type 2 Diabetes and Colorectal Cancer safe for humans?

The research does not provide specific safety data for the Nutrition Education Program, but it suggests that regular physical activity and a diet high in fruits and vegetables are generally safe and may help prevent colorectal cancer. ^{7 8 9 10 11}

Is the Nutrition Education Program for Type 2 Diabetes and Colorectal Cancer safe for humans?

The research does not provide specific safety data for the Nutrition Education Program, but it suggests that regular physical activity and a diet high in fruits and vegetables are generally safe and may help prevent colorectal cancer. ^{7 8 9 10 11}

How does the Nutrition Education Program for Type 2 Diabetes and Colorectal Cancer differ from other treatments?

This treatment is unique because it focuses on providing personalized nutrition education to improve dietary habits, which is not typically emphasized in standard medical treatments for type 2 diabetes and colorectal cancer. It aims to empower patients with knowledge to manage their conditions through diet, which is often overlooked in traditional medical education and practice. ^{12 13 14 15 16}

How does the Nutrition Education Program for Type 2 Diabetes and Colorectal Cancer differ from other treatments?

This treatment is unique because it focuses on providing personalized nutrition education to improve dietary habits, which is not typically emphasized in standard medical treatments for type 2 diabetes and colorectal cancer. It aims to empower patients with knowledge to manage their conditions through diet, which is often overlooked in traditional medical education and practice. ^{12 13 14 15 16}

Research Team

Lucy Kibe, DrPH

Principal Investigator

Charles Drew University of Medicine and Science

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Gender disparities in dietary status and its risk factors in underserved populations. [2012]

2. Korea (South) 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]. [2013]

3. Scotland pubmed.ncbi.nlm.nih.gov

Influence of albumin and physical activity on postoperative recovery in patients with colorectal cancer: An observational study. [2021]

4. Korea (South) 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. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Health services research in colorectal cancer: a quasi-experimental interventional pilot study on in- and outpatient oncology. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Nutritional Adequacy and Diet Quality in Colorectal Cancer Patients Postsurgery: A Pilot Study. [2017]

7. Czech Republic pubmed.ncbi.nlm.nih.gov

[Colorectal cancer and diabetes]. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

The association of glycemic load and carbohydrate intake with colorectal cancer risk in the Multiethnic Cohort Study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Association of dietary insulinemic potential and colorectal cancer risk in men and women. [2023]

11. United States 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. [2017]

12. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of a psycho-educational nutritional program in diabetic patients. [2022]

13. Switzerland 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. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Evaluation of US Veterans Nutrition Education for Diabetes Prevention. [2019]

15. United States pubmed.ncbi.nlm.nih.gov

Translating current dietary guidelines into a culturally tailored nutrition education program for Korean American immigrants with type 2 diabetes. [2022]

16. United States pubmed.ncbi.nlm.nih.gov

Nutrition in medicine: nutrition education for medical students and residents. [2022]