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

21 Years
80 Years
Not Enrolling
Cancer, Heart Disease

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Trial Information

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

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

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.

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

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 -

Type of Study:


Study Design:

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

Outcome Measure:

Dietary Quality

Outcome Description:

Dietary quality was measured by the Alternative Healthy Eating Index (AHEI), a scale of healthy eating that goes from zero to 80 (best score).

Outcome Time Frame:

6 mos

Safety Issue:


Principal Investigator

Barbara C Olendzki, RD MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMass Medical School


United States: Institutional Review Board

Study ID:

IRG 93-033



Start Date:

May 2007

Completion Date:

February 2009

Related Keywords:

  • Cancer
  • Heart Disease
  • Nutrition
  • Dietary Quality
  • Weight loss
  • Heart Diseases



UMass Medical SchoolWorcester, Massachusetts  01655