Clinical trial NCT00561977: Cancer Dietary Objectives Study
Official title: Finding a Simple Message to Improve Dietary Quality for Cancer and Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Heart Disease
Keywords: Nutrition
Dietary Quality
Weight loss
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2007-11-21
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Dietary Quality
timeFrame: 6 mos
measure: Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).
timeFrame: 3 months
Secondary outcomes:
measure: Change in Weight From Baseline to 3 Months
timeFrame: 3 months
measure: Change in Weight From Baseline to 6 Months
timeFrame: 6 months
measure: Change in Calories From Baseline to 3 Months
timeFrame: 3 months
measure: Change in Calories From Baseline to 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Barbara C Olendzki, RD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.