Cancer Dietary Objectives Study

Cancer Clinical Trial

— CanDo  

Official title:

Finding a Simple Message to Improve Dietary Quality for Cancer and Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561977
• Other study ID #: IRG 93-033
• Status: Completed
• Phase: N/A
• First received: November 20, 2007
• Last updated: August 2, 2011
• Start date: May 2007
• Est. completion date: February 2009

Study information

• Verified date: August 2011
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

We hypothesize that adding beneficial high fiber foods to the diet will result in better overall dietary quality (measured by the Alternate Healthy Eating Index), which has been shown to be associated with cancer, than either reducing saturated fat, or a combination of high fiber and low saturated fat.

Description:

Summary of Grant:

Several studies have demonstrated that poor dietary quality is associated with obesity and certain cancers, such as gastrointestinal, colorectal, and hormonal cancers. Dietary interventions aimed at improving diet are plagued by poor adherence, possibly due to the complexity of changing multiple diet components. Complex public health messages are associated with worse adherence and reduced capacity to impact health outcomes. If a simple public health recommendation for diet was effective at changing multiple aspects of diet, adherence and impact could be maximized. However, research has yet to test which single dietary message has the greatest impact on overall diet quality, and consequently, potential for cancer and heart disease prevention. Thus far, dietary interventions have tested varying combinations of multiple recommendations; however, a single dietary recommendation may have a synergistic beneficial effect on other areas of diet, precluding the need to make the message overly complex.

The present study compares 3 dietary change conditions that are hypothesized to have high potential for synergistic effects on other unaddressed areas of diet, and consequently overall dietary quality. Patients were randomized to one of three arms:

1. low saturated fat diet (≤7% of total calories);

2. high fiber diet (≥30 grams of total fiber per day);

3. combination arm: low saturated fat and high fiber.

Each participant was instructed to reduce calories by -500 kcal/day from his/her resting metabolic rate (RMR), but total calories was not less than 1200 calories per day.

Additionally, Dr. Ira Ockene, professor of medicine, director of preventive cardiology program, generously offered to pay for blood draws and blood lipids and glucose analysis at each visit to make the study valuable from both cancer and heart disease research perspectives.

Specific aims:

1. Develop intervention materials. Intervention materials that specifically aid participants towards a low saturated fat or high fiber diet, or combination change developed for each condition.

2. Preliminary test of intervention. We will calculate change in diet quality, lipids, body weight, waist circumference, and blood pressure at 3- and 6-months. We hypothesize that the single change conditions will produce more changes than the complex condition and that adding beneficial high fiber foods to the diet will result in improved dietary quality (measured by the Alternative Healthy Eating Index) than reducing saturated fat. Secondary outcomes include calorie intake, micro- and macronutrients at baseline, physical activity, and observe changes at 3- and 6-months.

3. Adherence. We will examine adherence to the treatment protocol so that appropriate adjustments to the intervention can be made, if necessary, to enhance adherence in the larger randomized clinical trial.

4. Data for sample size estimation. We will document means and standard deviations on measures so that sample size can be estimated for the larger randomized clinical trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

1. BMI =25, and =40.

2. >=21 years of age, less than 81 years of age.

3. has primary care physician's approval to participate in all aspects of the study,

4. speaks, reads, and understands English at 6th grade level minimum

5. residing in local area for the duration of the study.

6. available for bi-monthly sessions (6 individual nutrition counseling visits)

Exclusion Criteria:

1. presence of a psychological disorder that will limit his/her ability to participate (such as an eating disorder, uncontrolled bipolar disorder)

2. unwilling to provide informed consent

3. presence of unstable medical disorder (e.g., uncontrolled hypertension, uncontrolled diabetes, etc), or a medical disorder associated with a life expectancy less than 2 years.

4. currently taking any medication known to affect weight or appetite

5. smokes more than 3 cigarettes a day on average

6. Has a dietary restriction that precludes changing to the healthy diet, i.e.; Crohn's disease, ulcerative colitis, renal disease, active diverticulitis, etc.

7. currently following a specific diet plan (low saturated fat/meat, or high fiber)

8. does not have a telephone

9. Pregnant, or planning to become pregnant (participant will be asked this question in telephone screening. If the participant becomes pregnant, they are asked to inform the principal investigator)

10. Has an active drug or alcohol problem within the past year -

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer
• Heart Disease
• Heart Diseases

Intervention

Behavioral:
• High Fiber Diet
high fiber diet (=30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
• low saturated fat diet
low saturated fat diet (=7% of total calories); -500 calories from RMR, not less than 1200 kcal/day.
• Combination diet
combination low saturated fat high fiber diet, with calorie restriction as specified.

Locations

Country	Name	City	State
United States	UMass Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Olendzki BC, Ma Y, Schneider KL, Merriam P, Culver AL, Ockene IS, Pagoto S. A simple dietary message to improve dietary quality: Results from a pilot investigation. Nutrition. 2009 Jul-Aug;25(7-8):736-44. doi: 10.1016/j.nut.2009.01.009. Epub 2009 Apr 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary Quality	Dietary quality was measured by the Alternative Healthy Eating Index (AHEI), a scale of healthy eating that goes from zero to 80 (best score).	6 mos	No
Primary	Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).	The AHEI consists of 8 components (eg, vegetables,trans fat). Each contributed 0-10 points to the total score; a score of 10 indicates that the recommendations were fully met, whereas a score of 0 represents the least healthy dietary behavior. Intermediate intakes were scored proportionately between 0 and 10. All component scores were summed to obtain a total AHEI score ranging from zero(worst) to 80(best).	3 months	No
Secondary	Change in Weight From Baseline to 3 Months		3 months	No
Secondary	Change in Weight From Baseline to 6 Months		6 months	No
Secondary	Change in Calories From Baseline to 3 Months	kilocalories	3 months	No
Secondary	Change in Calories From Baseline to 6 Months	kilocalories	6 months	No