![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
University of Massachusetts American Cancer Society |
---|---|
Information provided by: | University of Massachusetts |
ClinicalTrials.gov Identifier: | NCT00561977 |
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.
Condition | Intervention |
---|---|
Cancer Heart Disease |
Behavioral: High Fiber Diet Behavioral: low saturated fat diet Behavioral: Combination diet |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Finding a Simple Message to Improve Dietary Quality for Cancer and Heart Disease |
Estimated Enrollment: | 36 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2009 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
High Fiber Diet: Active Comparator
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.
|
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: Active Comparator
low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
|
Behavioral: low saturated fat diet
low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal/day.
|
Combination Diet: Active Comparator
Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
|
Behavioral: Combination diet
combination low saturated fat high fiber diet, with calorie restriction as specified.
|
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:
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:
Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barbara C Olendzki, RD, MPH | 508-856-5195 | barbara.olendzki@umassmed.edu |
United States, Massachusetts | |
UMass Medical School | Recruiting |
Worcester, Massachusetts, United States, 01655 | |
Contact: Barbara C Olendzki, RD MPH 508-856-5195 barbara.olendzki@umassmed.edu | |
Principal Investigator: Barbara C Olendzki, RD MPH | |
Sub-Investigator: Yunsheng MA, PhD | |
Sub-Investigator: Ira Ockene, MD | |
Sub-Investigator: Phil Merriam, MSPH | |
Sub-Investigator: Sherry Pagoto, PhD |
Principal Investigator: | Barbara C Olendzki, RD MPH | UMass Medical School |
Responsible Party: | UMass Medical School ( Barbara Olendzki, Nutrition Program Director ) |
Study ID Numbers: | IRG 93-033 |
Study First Received: | November 20, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00561977 |
Health Authority: | United States: Institutional Review Board |
Nutrition Dietary Quality Weight loss |
Body Weight Signs and Symptoms Heart Diseases Weight Loss |
Cardiovascular Diseases |